GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies

• ClinicalTrials.gov Identifier: NCT04824794
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: May 17, 2024
• Sponsor: Genmab
• Information provided by (Responsible Party): Genmab

Tracking Information

• First Submitted Date: March 9, 2021
• First Posted Date: April 1, 2021
• Last Update Posted Date: May 17, 2024
• Actual Study Start Date: March 9, 2021
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2024)

• 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) version 5.0.
• 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) ]
• 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.
• 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.

Original Primary Outcome Measures (submitted: March 29, 2021)

• Escalation: Dose limiting toxicities (DLTs) [ Time Frame: DLTs will be assessed during the first cycle (21 days) in each cohort ]
  Incidence of DLTs
• Escalation: Adverse events [ Time Frame: AEs are collected throughout study until the end of the safety follow-up period (30 days after last dose). ]
  To assess the safety and tolerability of GEN3014 throughout the treatment period of patients participating in the trial

Current Secondary Outcome Measures (submitted: January 12, 2024)

• Dose Escalation: Maximum (peak) Plasma Concentration (Cmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Dose Escalation: Time to Reach Cmax (Tmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Dose Escalation: Pre-dose (trough) Concentrations (Ctrough) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
• Dose Escalation: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last) [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Dose Escalation: Area Under the Concentration Time Curve From Zero to 168 hours (AUC0-168 h) [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Dose Escalation: Accumulation Ratio in Cmax (RA, Cmax) [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Dose Escalation: Accumulation Ratio in AUC (RA, AUC) [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Dose Escalation: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014 [ Time Frame: From first dose until treatment discontinuation (Up to 8 years) ]
• 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.
• 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.
• 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 time 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.
• 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.
• 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 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.
• 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.
• 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.
• 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 time 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.
• 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.
• 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.
• 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.
• Expansion Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) per CTCAE Version 5.0 [ Time Frame: From first dose until the end of the safety follow-up period (30 days after last dose) ]
• 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) ]
• Expansion Part A: Maximum (peak) Plasma Concentration (Cmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Expansion Part A: Time to Reach Cmax (Tmax) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Expansion Part A: Pre-dose (trough) Concentrations (Ctrough) of GEN3014 [ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]
• 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 up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• 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 up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Expansion Part A: Accumulation Ratio in Cmax (RA, Cmax) [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Expansion Part A: Accumulation Ratio in AUC (RA, AUC) [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Expansion Part A: Accumulation Ratio in Ctrough (RA,Ctrough) [ Time Frame: Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years) ]
• Expansion Part B: Ctrough Levels of GEN3014 IV or Daratumumab SC on Cycle 3 Day 1 [ Time Frame: Cycle 3 Day 1 ]
• Expansion Part B: Very Good Partial Response (VGPR), or better of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
• Expansion Part B: Complete Response (CR) or better of GEN3014 IV vs Daratumumab SC [ Time Frame: Up to 8 years ]
• 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 time of disease progression or death (due to any cause), whichever comes first based on IMWG criteria for MM participants.
• 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.
• 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.
• 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.
• 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.
• Expansion Part B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) per CTCAE Version 5.0 [ Time Frame: From first dose until the end of the safety follow-up period (30 days after last dose) ]
• Expansion Part B: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014, Anti-daratumumab Antibodies and Anti-recombinant Human Hyaluronidase PH20 (rHuPH20) [ Time Frame: From first dose until treatment discontinuation (Up to 8 years) ]

Original Secondary Outcome Measures (submitted: March 29, 2021)

• Escalation: To establish the pharmacokinetic profile (PK) profile of GEN3014 [ Time Frame: Assed throughout trial until the end of the safety follow-up period (30 days after last dose)] ]
  Maximum concentration of GEN3014 (Cmax) after dosing
• Escalation: To establish the PK profile of GEN3014 [ Time Frame: Assed throughout trial until the end of the safety follow-up period (30 days after last dose)] ]
  Time after dosing at which the maximum drug concentration was observed (Tmax)
• Escalation: To establish the PK profile of GEN3014 [ Time Frame: Assed throughout trial until the end of the safety follow-up period (30 days after last dose)] ]
  Time after dosing at which the lowest drug concentration is observed before the next dose is administered (C_Trough)
• Escalation: To establish the PK profile of GEN3014 [ Time Frame: Assed throughout trial until the end of the safety follow-up period (30 days after last dose)] ]
  Area-under-the-concentration-time curve from zero to last quantifiable sample(AUC_0-C last)
• Escalation: To establish the PK profile of GEN3014 [ Time Frame: Assed throughout trial until the end of the safety follow-up period (30 days after last dose)] ]
  Area-under-the-concentration-time curve from zero to 168 h (AUC_0-168 h)
• Escalation: To establish the PK profile of GEN3014 [ Time Frame: Assed throughout trial until the end of the safety follow-up period (30 days after last dose)] ]
  Accumulation ratios in Cmax (R_A, Cmax)
• Escalation: To establish the PK profile of GEN3014 [ Time Frame: Assed throughout trial until the end of the safety follow-up period (30 days after last dose)] ]
  Accumulation ratios in area-under-the-concentration-time curve (R_A, AUC)
• Escalation: Evaluate immunogenicity of GEN3014 [ Time Frame: ADA are collected throughout trial until the end of the safety follow-up period (30 days after last dose) ]
  Anti-drug antibody response (ADA)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies
• Official Title: An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

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 subcutaneous (SC) daratumumab in ex-US countries.

Participants will receive either 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.

Detailed Description

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

In the dose escalation phase GEN314 will be evaluated in RRMM and relapsed and refractory acute myeloid leukemia (R/R AML). The participants 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.

In Expansion Part A, GEN3014 will be further evaluated in 4 cohorts: anti-CD38 monoclonal antibody (mAb)-naive RRMM, anti-CD38 mAb-refractory RRMM, relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), and R/R AML at the RP2D identified from the Dose Escalation per protocol. In 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 Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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

Condition

• Relapsed or Refractory Multiple Myeloma (RRMM)
• Diffuse Large B Cell Lymphoma (DLBCL)
• Acute Myeloid Leukemia (AML)

Intervention

• Biological: GEN3014
  GEN3014 is administered by IV infusion.
  Other Name: HexaBody®-CD38
• Drug: Daratumumab
  Daratumumab is administered by SC injections.
  Other Name: DARZALEX FASPRO®

Study Arms

• 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)

  Intervention: Biological: GEN3014
• Active Comparator: Daratumumab

  Participants in Expansion Part B with

  - RRMM (anti-CD38 mAb-naïve)

  Intervention: Drug: Daratumumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 9, 2023): 252
• Original Estimated Enrollment (submitted: March 29, 2021): 152
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria

• Must have fresh bone marrow samples collected at Screening for RRMM, R/R AML, and R/R DLBCL with suspected bone marrow involvement.
• 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.
• 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 proteasome inhibitor (PI) and an immunomodulatory imide drug (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 participants 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. Note: Relapse is defined by BM blasts ≥5% in patients who have been in CR previously, or reappearance of blasts in the blood, or development of extramedullary AML. Refractory is defined as not being able to achieve a CR after the initial therapy.
• 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 chimeric antigen receptor T cell (CAR-T), bispecific antibody (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.
• White blood cell (WBC) counts ≥50,000/microliter (μL) in peripheral blood that cannot be controlled by hydroxyurea prior to the first dose of GEN3014.
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Bosnia and Herzegovina, Czechia, Denmark, France, Georgia, Greece, Hungary, Korea, Republic of, Malaysia, Moldova, Republic of, Netherlands, New Zealand, North Macedonia, Poland, Spain, Sweden, Ukraine, United States

Administrative Information

• NCT Number: NCT04824794
• Other Study ID Numbers: GCT3014-01; 2020-003781-40 ( EudraCT Number ); NL75422.056.21 ( Registry Identifier: The Netherlands CCMO ); 2023-507086-26-00 ( EU Trial (CTIS) Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Genmab
• Original Responsible Party: Same as current
• Current Study Sponsor: Genmab
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Study Official; Genmab

• PRS Account: Genmab
• Verification Date: May 2024