GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies

• ClinicalTrials.gov Identifier: NCT04824794
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: October 5, 2023
• Sponsor: Genmab
• Information provided by (Responsible Party): Genmab

Study Description

Brief Summary:

The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed or refractory multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts:

1. The Dose Escalation will test increasing doses of GEN3014 to find a safe dose level to be tested in the other two parts.
2. Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation Part.
3. Expansion Part B will compare intravenous (IV) GEN3014 with the approved multiple myeloma drug, subcutaneous (SC) daratumumab. Participants in the US will not participate Expansion Part B.

Participants will receive either investigational GEN3014 or daratumumab; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma (MM); Diffuse Large B Cell Lymphoma (DLBCL); Acute Myeloid Leukemia (AML)	Biological: GEN3014; Drug: Daratumumab	Phase 1; Phase 2

Detailed Description:

This trial will be conducted in 3 parts: Dose Escalation (phase 1), Expansion Parts, A and B (phase 2).

All participants in the Dose Escalation, GEN3014 will be evaluated in RRMM and R/R AML, will receive GEN3014, administered at various dose levels in 28-day cycles. Dose Limiting Toxicities (DLTs) will be assessed during the first treatment cycle and the Maximum Tolerated Dose (MTD) and/or Recommended phase 2 dose (RP2D) will be determined.

Expansion Part A, GEN3014 will be further evaluated in 4 cohorts: anti-CD38 mAb-naive RRMM, anti-CD38 mAb-refractory RRMM, R/R DLBCL, and R/R AML at the RP2D identified from the Dose Escalation per protocol. Expansion Part B, GEN3014 IV will be compared to daratumumab SC, head-to-head (H2H) to evaluate whether GEN3014 may be more potent in anti-CD38 mAb-naïve RRMM participants.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Dose escalation part is sequential while the expansion Part A cohorts are parallel. Expansion Part B is sequential to Expansion Part A RRMM cohort. In Expansion Part B, participants with RRMM are randomized (1:1) to treatment.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
• Actual Study Start Date: March 9, 2021
• Estimated Primary Completion Date: October 2024
• Estimated Study Completion Date: February 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: GEN3014; Experimental: GEN3014 Participants in Dose Escalation phase with; Relapsed or refractory myeloid myeloma (RRMM); R/R acute myeloid leukemia (AML) Participants in Expansion Part A with; RRMM (anti-CD38 mAb-naïve); RRMM (anti-CD38 mAb-refractory); R/R diffuse large B-cell lymphoma (DLBCL); R/R AML Participants in Expansion Part B with • RRMM (anti-CD38 mAb-naïve)	Biological: GEN3014; GEN3014 is administered by intravenous (IV) infusion.; Other Name: HexaBody®-CD38
Active Comparator: Daratumumab; Participants in Expansion Part B with - RRMM (anti-CD38 mAb-naïve)	Drug: Daratumumab; Daratumumab is administered by subcutaneous (SC) injections.; Other Name: DARZALEX FASPRO®

Outcome Measures

Primary Outcome Measures :

1. Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days during the first cycle ]
   To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
2. Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose until the end of the safety follow-up period (30 days after last dose) ]
3. Expansion Part A: Objective Response Rate (ORR) of GEN3014 [ Time Frame: Up to 8 years ]
   ORR is defined as the percentage of participants with a partial response (PR), or better based on International Myeloma Working Group (IMWG) criteria for MM participants, based on Lugano criteria for DLBCL participants, and based on International Working Group (IWG) response criteria for AML participants.
4. Expansion Part B: Objective Response Rate (ORR) of GEN3014 IV vs Daratumumab SC in Anti-CD38 mAb-naive RRMM Participants [ Time Frame: Up to 8 years ]
   ORR is defined as the percentage of participants with a PR, or better based on IMWG criteria.

Secondary Outcome Measures :

1. Dose Escalation: Maximum (peak) Plasma Concentration (Cmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
2. Dose Escalation: Time to Reach Cmax (Tmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
3. Dose Escalation: Pre-dose (trough) Concentrations (Cthrough) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
4. Dose Escalation: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
5. Dose Escalation: Area Under the Concentration Time Curve From Zero to 168 hours (AUC0-168 h) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
6. Dose Escalation: Accumulation Ratio in Cmax (RA, Cmax) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
7. Dose Escalation: Accumulation Ratio in AUC (RA, AUC) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
8. Dose Escalation: Number of NK-cells and Other Leukocytes Subsets [ Time Frame: Predose and postdose at multiple timepoints of each Cycle up to Cycle 6 and thereafter only in even Cycles (Cycle length=28 days) ]
   NK-cells and other leukocytes absolute counts in blood and tumor samples will be assessed.
9. Dose Escalation: Percentage of NK-cells and Other Leukocytes Subsets [ Time Frame: Predose and postdose at multiple timepoints of each Cycle up to Cycle 6 and thereafter only in even Cycles (Cycle length=28 days) ]
   NK-cells and other leukocytes percentage in blood and tumor samples will be assessed.
10. Dose Escalation: Change From Baseline in Cytokine levels up to Cycle 1 [ Time Frame: Cycle 1 (cycle length = 28 days) ]
    Change in cytokine levels in blood samples will be assessed.
11. Dose Escalation: Change From Baseline in CH50 and C2 level up to Cycle 1 [ Time Frame: Cycle 1 (cycle length = 28 days) ]
    Change in CH50 and C2 levels in blood samples will be assessed.
12. Dose Escalation: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014 [ Time Frame: From first dose until treatment discontinuation (Up to 8 years) ]
13. Dose Escalation: Objective Response Rate (ORR) of GEN3014 [ Time Frame: Up to 8 years ]
    ORR is defined as the percentage of participants with a PR or better based on IMWG criteria for MM participants, and based on IWG response criteria for AML participants.
14. Dose Escalation: Clinical Benefit Rate (CBR) of GEN3014 [ Time Frame: Up to 8 years ]
    CBR was determined by the investigator according to the IMWG response criteria for MM participants.
15. Dose Escalation: Duration of Response (DOR) of GEN3014 [ Time Frame: Up to 8 years ]
    DOR is defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever comes first based on IMWG criteria for MM participants and based on IWG response criteria for AML participants.
16. Dose Escalation: Time-to-response (TTR) of GEN3014 [ Time Frame: Up to 8 years ]
    TTR is defined as the time from date of first dose to time of response (PR or better) based on IMWG criteria for MM participants and based on IWG response criteria for AML participants.
17. Dose Escalation: Progression-free survival (PFS) of GEN3014 [ Time Frame: Up to 8 years ]
    PFS is defined as the time from the date of the first dose, or date of randomization to the date of progression or death (due to any cause), whichever comes first based on IMWG criteria for MM participants and based on IWG response criteria for AML participants.
18. Dose Escalation: Overall Survival (OS) of GEN3014 [ Time Frame: Up to 8 years ]
    OS is defined as the time from the date of first dose to the date of death due to any cause.
19. Expansion Part A: Clinical Benefit Rate (CBR) of GEN3014 [ Time Frame: Up to 8 years ]
    CBR was determined by the investigator according to the IMWG response criteria for MM participants.
20. Expansion Part A: Duration of Response (DOR) of GEN3014 [ Time Frame: Up to 8 years ]
    DOR is defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever comes first based on IMWG criteria for MM participants, based on Lugano criteria for DLBCL participants, and based on IWG response criteria for AML participants.
21. Expansion Part A: Time-to-response (TTR) of GEN3014 [ Time Frame: Up to 8 years ]
    TTR is defined as the time from date of first dose to time of response (PR or better) for MM participants, based on Lugano criteria for DLBCL participants, and based on IWG response criteria for AML participants.
22. Expansion Part A: Progression-free survival (PFS) of GEN3014 [ Time Frame: Up to 8 years ]
    PFS is defined as the time from the date of the first dose to the date of progression or death (due to any cause), whichever comes first based on IMWG criteria for MM participants, based on Lugano criteria for DLBCL participants, and based on IWG response criteria for AML participants.
23. Expansion Part A: Overall Survival (OS) of GEN3014 [ Time Frame: Up to 8 years ]
    OS is defined as the time from the date of first dose to the date of death due to any cause.
24. Expansion Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) per CTCAE v5.0 [ Time Frame: From first dose until the end of the safety follow-up period (30 days after last dose) ]
25. Expansion Part A: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014 [ Time Frame: From first dose until treatment discontinuation (Up to 8 years) ]
26. Expansion Part A: Maximum (peak) Plasma Concentration (Cmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
27. Expansion Part A: Time to Reach Cmax (Tmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
28. Expansion Part A: Pre-dose (trough) Concentrations (Cthrough) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
29. Expansion Part A: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
30. Expansion Part A: Area Under the Concentration Time Curve From Zero to 168 hours (AUC0-168 h) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
31. Expansion Part A: Accumulation Ratio in Cmax (RA, Cmax) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
32. Expansion Part A: Accumulation Ratio in AUC (RA, AUC) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
33. Expansion Part A: Accumulation Ratio in Cthrough (RA,Cthrough) [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
34. Expansion Part A: Number of NK-cells and Other Leukocytes Subsets [ Time Frame: Predose and postdose at multiple timepoints of each Cycle up to Cycle 6 and thereafter only in even Cycles (Cycle length=28 days) ]
    NK-cells and other leukocytes absolute counts in blood and tumor samples will be assessed.
35. Expansion Part A: Percentage of NK-cells and Other Leukocytes Subsets [ Time Frame: Predose and postdose at multiple timepoints of each Cycle up to Cycle 6 and thereafter only in even Cycles (Cycle length=28 days) ]
    NK-cells and other leukocytes percentage in blood and tumor samples will be assessed.
36. Expansion Part A: Change From Baseline in Cytokine levels up to Cycle 1 [ Time Frame: Cycle 1 (cycle length = 28 days) ]
    Change in cytokine levels in blood samples will be assessed.
37. Expansion Part A: Change From Baseline in CH50 and C2 level up to Cycle 1 [ Time Frame: Cycle 1 (cycle length = 28 days) ]
    Change in CH50 and C2 levels in blood samples will be assessed.
38. Expansion Part B: Ctrough levels of GEN3014 IV or Daratumumab SC on Cycle 3 Day 1 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
39. Expansion Part B: Very Good Partial Response (VGPR), or better of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
40. Expansion Part B: Complete Response (CR) or better of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
41. Expansion Part B: Duration of Response (DOR) of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
    DOR is defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever comes first based on IMWG criteria for MM participants.
42. Expansion Part B: Time-to-response (TTR) of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
    TTR is defined as the time from date of randomization, to time of response (PR or better) based on IMWG criteria for MM participants.
43. Expansion Part B: Progression-free Survival (PFS) of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
    PFS is defined as the time from date of randomization to the date of progression or death (due to any cause), whichever comes first based on IMWG criteria for MM participants.
44. Expansion Part B: Overall Survival (OS) of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
    OS is defined as the time from date of randomization to the date of death due to any cause.
45. Expansion Part B: Time to Next Therapy (TTNT) [ Time Frame: Up to 8 years ]
    Time to next therapy (TTNT) for participants in the Expansion Part B is defined as the time from date of randomization to the start of subsequent anti-cancer therapy.
46. Expansion Part B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) per CTCAE v5.0 [ Time Frame: From first dose until the end of the safety follow-up period (30 days after last dose) ]
47. Expansion Part B: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014, Anti-daratumumab antibodies and Anti- rHuPH20 [ Time Frame: From first dose until treatment discontinuation (Up to 8 years) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria

• Must have fresh bone marrow samples collected at Screening.
• Dose Escalation phase, Expansion part A (for MM and AML) and Expansion part B- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2. Expansion part A (for DLBCL): ECOG PS 0 or 1.
• Expansion part A - Has acceptable laboratory test results during the Screening period.
• A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3014 or daratumumab SC administration.
• A woman of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) at Screening and additionally, for Expansion Part B, within 72 hours of the first dose of study treatment prior to dosing.
• A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC.
• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control and all men must not donate sperm during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC.

Specific for RRMM:

• Must have documented multiple myeloma as defined by the criteria below and have evidence of disease progression on the most recent prior treatment regimen based on IMWG criteria:

  • Prior documentation of monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy-proven plasmacytoma and,

  • Measurable disease at baseline as defined by any of the following:

    • Immunoglobulin (Ig) G, IgA, IgD, or IgM myeloma: Serum M-protein level ≥0.5 g/dL (≥5 g/L) or urine M protein level ≥200 mg/24 hours or,
    • Light chain myeloma: Serum Ig free light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.

Note: Participants with RRMM must have exhausted standard therapies, at the investigator's discretion.

• For anti-CD38 mAb-naive RRMM Cohort: Participant received at least 3 prior lines of therapy including a PI and an IMiD in any order, or is double refractory to a PI and an IMiD; or participant received ≥ 2 prior lines of therapy if 1 of those lines included a combination of PI and IMiD. Note: Participants should not have received any anti-CD38 antibody.
• Anti-CD38 mAb-naive RRMM subjects will be enrolled from ex-US countries
• Dose Escalation phase - For anti-CD38 mAb-treated RRMM Cohort: Participant has received at least 2 prior lines of therapy and must have discontinued daratumumab or isatuximab for at least 4 weeks prior to the first dose of GEN3014. Note: Participants should not have received any other anti-CD38 antibody except daratumumab or isatuximab.

Specific for R/R AML:

• Relapsed or refractory AML, both de novo or secondary; must have failed all conventional therapy. Acute promyelocytic leukemia (APL) is excluded from this trial.
• Participant with relapsed AML who received at least 2 prior therapies for AML with the exception of hydroxyurea.
• Participant with refractory AML who received at least 1 prior line of therapy for AML with the exception of hydroxyurea.
• Participant's life expectancy at Screening is judged to be at least 3 months.

Specific for DLBCL:

• Expansion phase: Relapsed or refractory DLBCL, both de novo or histologically transformed. Participants with R/R DLBCL must have exhausted standard therapies, at the investigator's discretion.
• Expansion phase: Received at least 2 prior lines of systemic therapy, with 1 being a CD20-containing chemoimmunotherapy.
• Expansion phase: Have at least 1 measurable site of disease as per Lugano criteria.
• Expansion phase: Must have available archival or fresh tumor tissue or both to submit to a central laboratory for CD38 assay.

Key Exclusion Criteria

• Prior treatment with any CD38-directed therapies (eg, daratumumab, isatuximab, CD38 CAR-T, bispecific Ab) in anti-CD38 mAb-naive RRMM Cohort. Note: Prior daratumumab or isatuximab exposure is allowed for anti-CD38 mAb-treated RRMM participants in the Dose Escalation and anti-CD38 mAb-refractory RRMM Cohort in the Expansion Part A.
• Treatment with an anti-cancer agent, chemotherapy, radiation therapy, or major surgery within 2 weeks prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B).
• Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B).
• Cumulative dose of corticosteroids more than the equivalent of ≥140 mg of prednisone within 2-week period before the first dose of study treatment (Dose Escalation and Expansion Part A) or maximum cumulative dose of dexamethasone 160 mg within 28 days of randomization (Expansion Part B).
• Has clinically significant cardiac disease.
• Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
• Primary central nervous system (CNS) tumor or known CNS involvement at Screening.
• Has known history/positive serology for hepatitis B.
• Known medical history or ongoing hepatitis C infection that has not been cured.
• Known history of seropositivity of human immunodeficiency virus (HIV) (Dose Escalation and Expansion Part A) or to be positive for HIV with details in the protocol (Expansion Part B).
• Currently receiving any other investigational agents.
• A woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of study treatment.
• A man who plans to father a child while enrolled in this trial or within 12 months after the last dose of study treatment.

Specific Exclusion Criteria for RRMM:

• Prior allogeneic hematopoietic stem cell transplant (HSCT).
• Autologous HSCT within 3 months of the first dose of GEN3014.

Specific Exclusion Criteria for R/R AML:

• <5% blasts in blood or bone marrow at Screening.
• Prior autologous HSCT.
• Allogenic HSCT within 3 months of the first dose of GEN3014.
• Active graft-versus-host-disease requiring immunosuppressive treatment. Any immunosuppressive medication (eg, calcineurin inhibitors) must be stopped ≥4 weeks prior to the first dose of GEN3014.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Contacts

Contact: Genmab Trial Information; +45 70202728; clinicaltrials@genmab.com

Locations

United States, Georgia

Winship Cancer Institute; Active, not recruiting

Atlanta, Georgia, United States, 30322

United States, New Jersey

John Theurer Cancer Center; Active, not recruiting

Hackensack, New Jersey, United States, 07601

United States, North Carolina

Levine Cancer Institute; Active, not recruiting

Charlotte, North Carolina, United States, 28150

United States, Ohio

University Hospitals Cleveland Medical Center; Recruiting

Cleveland, Ohio, United States, 44106

United States, Wisconsin

Medical college of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Australia

The Alfred Hospital; Recruiting

Melbourne, Australia

Royal Prince Alfred Hospital; Recruiting

Sydney, Australia

Czechia

Fakultni Nemocnice Brno; Active, not recruiting

Brno, Czechia

Vseobecna fakultni nemocnice; Active, not recruiting

Nové Město, Czechia

Fakultni Nemocnice Hradec Kralove FNHK; Recruiting

Nový Hradec Králové, Czechia

Fakultni Nemocnice Olomouc (FNOL); Active, not recruiting

Olomouc, Czechia

FNO - Fakultni nemocnice Ostrava; Active, not recruiting

Poruba, Czechia

Denmark

Aalborg Universitet; Recruiting

Aalborg, Denmark

Vejle Hospital; Recruiting

Vejle, Denmark

France

CHRU de Lille; Active, not recruiting

Lille, France

CHRU de Nantes; Active, not recruiting

Nantes, France

Georgia

ARENSIA Exploratory Medicine LLC; Recruiting

Tbilisi, Georgia

Greece

National & Kapodistrian University of Athens; Active, not recruiting

Athens, Greece

University of Athens NKUA; Active, not recruiting

Athens, Greece

University General Hospital of Patras; Active, not recruiting

Río, Greece

Ahepa University General hospital; Active, not recruiting

Thessaloníki, Greece

Hungary

Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet; Not yet recruiting

Budapest, Hungary

Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika; Not yet recruiting

Budapest, Hungary

SzSzB Megyei Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz; Not yet recruiting

Nyíregyháza, Hungary

Korea, Republic of

Chonnam National University Hwasun Hospital; Recruiting

Gwangju, Korea, Republic of

Pusan National University Hospital PNUH; Recruiting

Pusan, Korea, Republic of

Gachon University Gil Medical Center; Active, not recruiting

Seongnam, Korea, Republic of

Samsung Medical Center; Recruiting

Seoul, Korea, Republic of

Seoul National University Hospital; Not yet recruiting

Seoul, Korea, Republic of

Moldova, Republic of

Institute of Oncology, ARENSIA Exploratory Medicine; Recruiting

Chisinau, Moldova, Republic of

Netherlands

Maastricht UMC; Active, not recruiting

Maastricht, Netherlands

Erasmus MC; Recruiting

Rotterdam, Netherlands

UMC Utrecht; Active, not recruiting

Utrecht, Netherlands

Poland

University Centrum Kliniczne; Recruiting

Gdańsk, Poland

Pratia Onkologia Katowice; Recruiting

Katowice, Poland

Pratia MCM; Recruiting

Kraków, Poland

Wroclaw Medical University; Not yet recruiting

Wrocław, Poland

Spain

University of Navarra; Recruiting

Pamplona, Spain

University Hospital of Salamanca; Recruiting

Salamanca, Spain

Sweden

Karolinska Institute; Recruiting

Huddinge, Sweden

Universitetssjukhuset i Lund; Recruiting

Lund, Sweden

Ukraine

Arensia Exploratory Medicine; Recruiting

Kyiv, Ukraine

Sponsors and Collaborators

Genmab

Investigators

• Study Director: Study Official; Genmab

More Information

• Responsible Party: Genmab
• ClinicalTrials.gov Identifier: NCT04824794
• Other Study ID Numbers: GCT3014-01; 2020-003781-40 ( EudraCT Number ); NL75422.056.21 ( Registry Identifier: The Netherlands CCMO )
• First Posted: April 1, 2021
• Last Update Posted: October 5, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Genmab:

Hexabody®; Anti-CD38; monoclonal antibody

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Myeloid, Acute; Lymphoma, Large B-Cell, Diffuse; Hematologic Neoplasms; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Leukemia; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphatic Diseases; Neoplasms by Site; Daratumumab; Antineoplastic Agents