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Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04663347
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : April 3, 2024
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Genmab

Tracking Information
First Submitted Date  ICMJE October 27, 2020
First Posted Date  ICMJE December 11, 2020
Last Update Posted Date April 3, 2024
Actual Study Start Date  ICMJE November 3, 2020
Estimated Primary Completion Date March 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2023)
  • Part 1: Number of Participants With Dose limiting Toxicities (DLTs) [ Time Frame: During the first cycle (Cycle length= 28 days) in each cohort ]
    DLT events are defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
  • Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of trial medication to the maximum of 60 days after last dose of epcoritamab or initiation of subsequent anti-lymphoma therapy. ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
  • Part 2 (Except Arm 7): Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]
    ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • Dose Escalation Phase - Number of dose-limiting toxicities (DLTs) [ Time Frame: DLTs are evaluated during the first cycle (28 days) in each cohort ]
    To evaluate the safety of epcoritamab in combination with other agents
  • Dose Escalation Phase - Number of Adverse Events [ Time Frame: From first dose up to safety follow-up (60 days after last trial treatment) ]
    To evaluate the safety of epcoritamab in combination with other agents
  • Expansion Part - Preliminary anti-tumor activity [ Time Frame: Up to approximately 3 years after the last subject's first treatment ]
    To evaluate the overall response rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2023)
  • Part 1 and 2: Clearance (CL) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Volume of Distribution (Vd) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Plasma Trough (Pre-dose) Concentrations (Ctrough) of Epcoritamab [ Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) ]
  • Part 1 and 2: Number of Immune Cell Populations [ Time Frame: Up to 2 years ]
    Immune cell populations in peripheral blood and tumor biopsies will be assessed.
  • Part 1 and 2: Percentage of Immune Cell Populations [ Time Frame: Up to 2 years ]
    Immune cell populations in peripheral blood and tumor biopsies will be assessed.
  • Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3 [ Time Frame: Up to Cycle 3 (cycle length = 21 days for Arms 1, 4, 8 and 10; cycle length = 28 days for Arms 2, 3, 5, 6 and 9; cycle length = 28 days (Cycle 1) and 56 days (Cycles 2, 3) for Arm 7) ]
    Change in cytokine levels in peripheral blood samples will be assessed.
  • Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years) [ Time Frame: Up to 2 years ]
    Change in circulating tumor DNA levels will be assessed.
  • Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab [ Time Frame: Up to 3 years ]
  • Part 1: ORR [ Time Frame: Up to 3 years ]
    ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.
  • Part 1 and 2: Duration of Response (DOR) [ Time Frame: Up to 3 years ]
    DOR: the time from the first documentation of objective tumor response (CR or PR) to the date of first PD or death based on Lugano criteria.
  • Part 1 and 2: Time to Response (TTR) [ Time Frame: Up to 3 years ]
    TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR).
  • Part 1 and 2: Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
    PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause based on Lugano criteria.
  • Part 1 and 2: Overall Survival (OS) [ Time Frame: Up to 3 years ]
    OS is defined as the time from the date of first dose, to the date of death due to any cause.
  • Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT) [ Time Frame: Up to 3 years ]
    TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy.
  • Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity [ Time Frame: Up to 3 years ]
    It is defined as the percentage of participants with at least 1 MRD negative result.
  • Part 1 and 2: Duration of minimal residual disease (MRD) negativity [ Time Frame: Up to 3 years ]
  • Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity [ Time Frame: Up to 3 years ]
  • Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10 [ Time Frame: Up to 3 years ]
  • Part 2 (Arm 7): Percentage of Participants With CR [ Time Frame: Week 24, Week 48, and Week 96 ]
    It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration.
  • Part 1 and 2: Time to Complete Response (TTCR) [ Time Frame: Up to 3 years ]
    TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment.
  • Part 1 and 2: Duration of Complete Response (DoCR) [ Time Frame: Up to 3 years ]
    DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs first based on Lugano criteria.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluate PK parameter - Clearance
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluate PK parameter - Volume of distribution
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluate PK parameter - AUC0-last (Area under the concentration-time curve (AUC) from time zero to last quantifiable sample)
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluate PK parameter - Area under the concentration-time curve (AUC) from time zero to infinity
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluate PK parameter - Cmax (maximum (peak) plasma drug concentration)
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluatePK parameter - Tmax (time to reach maximum (peak) plasma concentration)
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluate PK parameters - Predose values
  • Pharmacokinetics concentration of epcoritamab [ Time Frame: From start of treatment throughout all treatment cycles (each cycle is 28 days) until LPLV, approximately 3 years ]
    To evaluate PK parameters - t½ (elimination half-life)
  • Incidence of anti-drug antibodies (ADAs) to Epcoritamab [ Time Frame: From start of treatment until end of treatment, approximately 24 months ]
    To evaluate immunogenicity
  • Duration of response (DOR) [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Time to response (TTR) [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Progressive-free survival (PFS) [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Overall survival (OS) [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Time to next anti-lymphoma therapy (TTNT) [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Rate of minimal residual disease (MRD) negativity [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Duration of minimal residual disease (MRD) negativity [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Safety run-in only: preliminary anti-tumor activity as measured by the overall response rate [ Time Frame: Approximately 3 years after the last subject's first treatment ]
    To evaluate the preliminary anti-tumor activity of epcoritamab in combination with other agents
  • Expansion only: Monitor number and severity of AEs [ Time Frame: Up to safety follow-up (up to 60days after last dose) ]
    To evaluate the safety and tolerability of epcoritamab in combination with other agents
  • Expansion only: Monitor number and severity of changes in laboratory values [ Time Frame: Up to safety follow-up (up to 60days after last dose) ]
    To evaluate the safety and tolerability of epcoritamab in combination with other agents
  • Expansion only: Monitor number of dose interruptions and delays [ Time Frame: Up to safety follow-up (up to 60days after last dose) ]
    To evaluate the safety and tolerability of epcoritamab in combination with other agents
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Official Title  ICMJE A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Brief Summary

A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL).

The trial consists of 10 different treatment arms. Arm 9 (follicular lymphoma (FL)) is still open for enrolment of new patients, while the other arms have closed their recruitment.
Detailed Description

All participants in the trial will receive epcoritamab, as monotherapy or in combination. The following regimens will be investigated:

  • Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated diffuse large B-cell lymphoma (DLBCL)
  • Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) FL
  • Arm 3: epcoritamab + rituximab and bendamustine (BR) in participants with previously untreated FL
  • Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in participants with R/R DLBCL eligible for autologous stem cell transplant (ASCT)
  • Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity
  • Arm 6: epcoritamab + R2 in participants with previously untreated FL
  • Arm 7: epcoritamab maintenance in participants with FL who achieve a complete response (CR) or a partial response (PR) with SOC treatment
  • Arm 8: epcoritamab + reduced dose of R-CHOP (R mini-CHOP) in participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline
  • Arm 9: epcoritamab + lenalidomide for second-line treatment in participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy
  • Arm 10: epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in participants with R/R DLBCL eligible for ASCT

The trial consists of two parts: Part 1 ('Dose Escalation') and Part 2 ('Dose Expansion'). The primary objective of Part 1 is safety, and it includes Arm 1-5 and Arm 10. Part 2 includes all 10 arms (Arm 1-10) and the primary goal of all arms, except Arm 7, is preliminary efficacy. For Arm 7, the primary goal is safety. Patients in Arm 1-5 and Arm 10 can only participate in either Part 1 or Part 2. Dose Limiting Toxicities (DLTs) will be assessed in Part 1 and for a selected number of patients in Arm 8 during a 28-day period ('safety-run phase'). The arms are conducted in parallel.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
Intervention  ICMJE
  • Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
    21-day cycles
    Other Name: R-CHOP
  • Drug: rituximab and lenalidomide
    28-day cycles
    Other Name: R2
  • Drug: rituximab and bendamustine
    28-day cycles
    Other Name: BR
  • Drug: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
    21-day cycles
    Other Name: R-DHAX/C
  • Drug: gemcitabine and oxaliplatin
    28-day cycles
    Other Name: GemOx
  • Biological: Epcoritamab
    Every week in cycle 1-4, every 3 weeks in cycle 5 and 6, followed by every 4 weeks in cycle 7 for a total of 1 year.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
  • Drug: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
    21-day cycles
    Other Name: R mini-CHOP
  • Drug: Lenalidomide
    28-day cycles
  • Drug: rituximab, ifosfamide, carboplatin, and etoposide phosphate
    21-day cycles
    Other Name: R-ICE
  • Biological: Epcoritamab
    Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
  • Biological: Epcoritamab
    Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
  • Biological: Epcoritamab
    Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
  • Biological: Epcoritamab
    Every week in cycle 1 and then every 8 weeks for a total of 2 years.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
  • Biological: Epcoritamab
    Every week in cycles 1 and 2, then every 3 weeks in cycles 3 to 6 and then every 4 weeks for cycles 7 and 8.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
  • Biological: Epcoritamab
    Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
  • Biological: Epcoritamab
    Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression.
    Other Names:
    • GEN3013
    • DuoBody®-CD3xCD20
    • EPKINLY™
Study Arms  ICMJE
  • Experimental: Arm 1 - Epcoritamab + R-CHOP
    In participants with previously untreated DLBCL.
    Interventions:
    • Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
    • Biological: Epcoritamab
  • Experimental: Arm 2 - Epcoritamab + R2
    In participants with R/R FL.
    Interventions:
    • Drug: rituximab and lenalidomide
    • Biological: Epcoritamab
  • Experimental: Arm 3 - Epcoritamab + BR
    In participants with previously untreated FL.
    Interventions:
    • Drug: rituximab and bendamustine
    • Biological: Epcoritamab
  • Experimental: Arm 4 - Epcoritamab + R-DHAX/C
    In participants with R/R DLBCL eligible for ASCT.
    Interventions:
    • Drug: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
    • Biological: Epcoritamab
  • Experimental: Arm 5 - Epcoritamab + GemOx
    In participants with R/R DLBCL ineligible ASCT.
    Interventions:
    • Drug: gemcitabine and oxaliplatin
    • Biological: Epcoritamab
  • Experimental: Arm 6 - Epcoritamab + R2
    In participants with previously untreated FL.
    Interventions:
    • Drug: rituximab and lenalidomide
    • Biological: Epcoritamab
  • Experimental: Arm 7 - Epcoritamab maintenance
    In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
    Intervention: Biological: Epcoritamab
  • Experimental: Arm 8 - Epcoritamab + R mini-CHOP
    In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
    Interventions:
    • Drug: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
    • Biological: Epcoritamab
  • Experimental: Arm 9 - Epcoritamab + Lenalidomide
    In participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
    Interventions:
    • Drug: Lenalidomide
    • Biological: Epcoritamab
  • Experimental: Arm 10 - Epcoritamab + R-ICE
    In participants with R/R DLBCL eligible for ASCT.
    Interventions:
    • Drug: rituximab, ifosfamide, carboplatin, and etoposide phosphate
    • Biological: Epcoritamab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2023)		 662
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2020)		 130
Estimated Study Completion Date  ICMJE March 31, 2029
Estimated Primary Completion Date March 31, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

  1. Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI)
  2. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
  3. Acceptable organ function at screening
  4. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
  5. If of childbearing potential subject must practicing a highly effective method of birth control
  6. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control

Arm 1:

  • Newly Diagnosed Documented diffuse large B-cell lymphoma (DLBCL)
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B

Arm 2: R/R FL

Arm 3: Newly diagnosed, previously untreated FL grade 1-3A

Arm 4:

  • Documented DLBCL and eligible for HDT-ASCT
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B

Arm 5:

  • Relapsed or refractory documented DLBCL and ineligible for HDT-ASCT
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B

Arm 6: Newly diagnosed, previously untreated FL grade 1-3A

Arm 7:

  • FL Grade 1-3A
  • If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.

Arm 8:

  • DLBCL, NOS
  • T-cell/histiocyte rich DLBCL
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B

Arm 9:

  • R/R FL
  • Progressed within 24 months of initiating first-line treatment

Arm 10:

  • Documented DLBCL and eligible for HDT-ASCT
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B

Key Exclusion Criteria

  1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
  2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
  3. Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
  4. Clinically significant cardiovascular disease
  5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  6. CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
  7. Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
  8. Known history of seropositivity of human immunodeficiency virus (HIV)
  9. Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
  10. Neuropathy > grade 1
  11. Receiving immunostimulatory agent
  12. Prior allogeneic HSCT
  13. Current seizure disorder requiring anti-epileptic therapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Genmab A/S Trial Information +45 70202728 clinicaltrials@genmab.com
Listed Location Countries  ICMJE Australia,   Belgium,   Czechia,   Denmark,   Finland,   France,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04663347
Other Study ID Numbers  ICMJE GCT3013-02
2020-000845-15 ( EudraCT Number )
NL74222.056.20 ( Registry Identifier: CCMO )
283235 ( Other Identifier: IRAS ID; UK Research Summaries Database )
2023-504805-35-00 ( Registry Identifier: EU CTIS )
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  ICMJE
Plan to Share IPD: No
Current Responsible Party Genmab
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Genmab
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE AbbVie
Investigators  ICMJE Not Provided
PRS Account Genmab
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP