Study on Epcoritamab vs. Observation for B-cell Lymphoma Patients Not Fully Responding After CAR-T Therapy

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06238648

Provider View

This clinical trial is comparing the effects of a new drug, epcoritamab, to standard observation in patients with B-cell lymphoma who haven't fully responded to previous CAR-T therapy. Epcoritamab is designed to help the immune system target and destroy cancer cells.

Patient Parameters

Program Overview

This study is testing whether epcoritamab, a new type of drug, can help patients with B-cell lymphoma achieve complete remission after they have not fully responded to CAR-T therapy. Epcoritamab works by connecting cancer cells to immune cells, helping the immune system attack the cancer. The trial will compare the effectiveness of epcoritamab to simply observing the patients without additional treatment.

Description

The main goal of this study is to see if epcoritamab can help more patients achieve a complete response, meaning no signs of cancer, compared to just observing them. Researchers will also look at how long patients live without the cancer getting worse, how long they live overall, and how long any response to treatment lasts. They will also check how quickly patients respond to the treatment and how safe and tolerable epcoritamab is.

Patients in the study will be randomly assigned to one of two groups. One group will receive epcoritamab injections under the skin on a specific schedule over 12 cycles, each lasting 28 days. They will also have regular scans and blood tests to monitor their progress. The other group will be observed according to standard care, with similar scans and tests.

After finishing the study treatment, patients will have follow-up visits every 90 days for the first year and then every 180 days for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Diagnosed with certain types of B-cell lymphoma, confirmed by recent lab tests.
  • Previously treated with specific CAR-T therapies and showing partial response.
  • Have measurable disease.
  • Good overall health with a performance status score of 0, 1, or 2.
  • Adequate blood cell counts and organ function based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Willing to provide consent and participate in follow-up visits.
  • Agree to provide tissue and blood samples for research purposes.

Exclusion Criteria

  • Have large tumors (7.5 cm or larger) after CAR-T therapy.
  • Have progressive, stable, or complete response disease after CAR-T therapy.
  • Pregnant or nursing women, or those not using contraception.
  • Previously treated with certain antibodies or therapies recently.
  • Have ongoing or severe side effects from CAR-T therapy.
  • Have certain brain or nervous system conditions.
  • Have serious health issues that could interfere with the study.
  • Have active infections or other cancers needing treatment recently.
  • Have significant heart problems or other serious health conditions.

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