RecruitingPhase 2NCT04889716

CAR-T Followed by Bispecific Antibodies

Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transformed Follicular Lymphomas


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

42 participants

Start Date

Nov 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The research study is being conducted to test the safety and effectiveness of the experimental drug mosunetuzumab (Cohort 1) or obinutuzumab and glofitamab (Cohort 2) when given after CAR (genetically modified) T cells. The study is for patients who have already received a CAR T-cell infusion. Some patients who join the study will receive mosunetuzumab, other patients later in the study may receive a different experimental drug (glofitamab, in combination with obinutuzumab).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding bispecific antibody drugs (drugs that help the immune system attack cancer from two directions at once) after CAR-T cell therapy can improve outcomes for patients with certain types of aggressive B-cell lymphoma that have come back or stopped responding to treatment. **You may be eligible if...** - You have relapsed or treatment-resistant large B-cell lymphoma (including transformed follicular lymphoma) - You have already received CAR-T cell therapy at least 30 days ago - Your cancer still shows measurable disease on imaging after CAR-T - You have a life expectancy of at least 12 weeks and adequate organ function **You may NOT be eligible if...** - You had serious toxicity from CAR-T therapy (severe immune reaction or neurological side effects) - You have a history of autoimmune disease (like lupus, rheumatoid arthritis, or multiple sclerosis) - You are pregnant, breastfeeding, or planning to become pregnant - You have had a solid organ transplant - You have an active serious infection or significant heart or lung disease - You have a history of progressive multifocal leukoencephalopathy (a serious brain infection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmosunetuzumab

1 mg IV on Cycle 1 Day 1; 2 mg IV Cycle 1 Day 8; 60 mg IV Cycle 1 Day 15; 60 mg IV on Cycle 2 Day 1 and then 30 mg IV every 21 days beginning Cycle 2 Day 1 through Cycle 17.

DRUGglofitamab

2.5 mg IV Cycle 1 Day 8; 10 mg IV Cycle 1 Day 15 then 30 mg every 21 days beginning Cycle 2 Day 1 through Cycle 12

DRUGobinutuzumab

1000 mg IV on Cycle 1 Day 1.


Locations(2)

University of Nebraska Medical Center

Omaha, Nebraska, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT04889716


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