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RecruitingLast updated: 5 February 2024

This phase I/II trial is trying to understand how safe and tolerable a targeted therapy drug (epcoritamab) is when combined with standard of care treatments, including chemotherapy, steroids and other targeted therapy drugs, in people with B-cell Non-Hodgkin LymphomaA 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

Clinical summary

Summary

This is a non-randomised trial with five experimental arms. Each arm has 2 parts: Part 1 (dose escalation) and Part 2 (expansion). Within each arm, participants can only participate in one part. Experimental Arm 1 is investigating epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Experimental Arm 2 is investigating epcoritamab + rituximab and lenalidomide (R2) in people with relapsed/refractory (R/R) follicular lymphoma (FL). Experimental Arm 3 is investigating epcoritamab + rituximab and bendamustine (BR) in people with previously untreated FL. Experimental Arm 4 is investigating epcoritamab + rituximab, cisplatin, cytarabine, and dexamethasone (R-DHAX/C) in people with R/R DLBCL eligible for autologous stem cell transplant (ASCT). Experimental Arm 5 is investigating epcoritamab + gemcitabine and oxaliplatin (GemOx) in people with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity.

Conditions

This trial is treating patients with B-cell non-Hodgkin lymphoma and Follicular lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Genmab

Scientific Title

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

Eligibility

Inclusion

  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

Exclusion

  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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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