Study on Glofitamab for Treating Mantle Cell Lymphoma After CAR-T Cell Therapy
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07003295
This clinical trial is testing the safety and effectiveness of the drug glofitamab, along with obinutuzumab, in patients with mantle cell lymphoma that has returned or not responded after CAR-T cell therapy. The study aims to see if these drugs can help the immune system fight cancer cells.
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Program Overview
This phase II study is exploring how well the drugs glofitamab and obinutuzumab work in treating patients with mantle cell lymphoma that has come back or not responded after previous treatments, including CAR-T cell therapy. Glofitamab is a special type of antibody that can attach to two different proteins on immune and cancer cells, potentially helping the immune system destroy cancer cells. Obinutuzumab is another antibody that may stop cancer cells from growing and spreading. The study will assess if these drugs are safe and effective for patients with relapsed or refractory mantle cell lymphoma.
Description
The main goal of this study is to find out how many patients with relapsed or refractory mantle cell lymphoma respond to the drug glofitamab after having CAR-T cell therapy. Researchers will also look at how many patients have a complete response, how long patients live without the disease getting worse, and overall survival rates over 24 months. They will monitor for serious side effects like cytokine release syndrome and neurological issues. The study will also explore how the drugs interact with cancer DNA in the blood and how they affect the immune system's response to cancer.
Participants will receive obinutuzumab through an IV on the first day or first two days of the first cycle, and glofitamab through an IV on specific days of each cycle. Each cycle lasts 21 days, and treatment can continue for up to 12 cycles unless the disease progresses or side effects become too severe. Patients will also have blood samples taken and undergo PET/CT scans throughout the study. After finishing the treatment, patients will have follow-up visits every three months for up to two years.
Eligibility Criteria
Inclusion Criteria
- Must have mantle cell lymphoma that has returned or not responded after previous treatments.
- Must have been treated with CAR-T cell therapy and not responded to or tolerated BTK inhibitors.
- Must have at least one measurable tumor.
- Must be 18 years or older.
- Must have a good performance status and meet specific blood count and organ function criteria.
- HIV-positive patients must have an undetectable viral load.
- Patients with a history of hepatitis B or C must have undetectable viral loads.
- Patients with treated brain metastases are eligible if stable.
- Must agree to use effective contraception during and after the study.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have unresolved side effects from previous cancer treatments.
- Cannot be taking other experimental drugs.
- Cannot have allergies to similar drugs.
- Pregnant or breastfeeding women cannot participate.
- Cannot have active infections or require treatment for infections within 14 days before the study.
- Cannot be on high-dose steroids or other immunosuppressive drugs.
- Cannot have certain viral infections or a history of specific immune system disorders.
- Cannot have had major surgery or received live vaccines recently.
- Cannot have certain heart conditions or a history of severe neurological disorders.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| JHU Sidney Kimmel Comprehensive Cancer Center LAO | 21231 | Baltimore | Maryland |
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