RecruitingPhase 2NCT06996132

Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma

A Phase 2 Clinical Study of CD20×CD3 Bispecific Antibody-Based Salvage Therapy Followed by CAR-T With or Without ASCT in R/R Aggressive B-Cell Lymphoma

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

25 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Aggressive B-cell Lymphoma

Summary

This study consists of two sequential treatment phases. In the first phase, patients with r/r aggressive B-NHL receive two cycles of glofitamab ± investigator-selected agents. In the second phase, patients eligible for CAR-T monotherapy undergo FC lymphodepletion followed by CAR-T infusion (2-4×10⁶/kg), while those eligible for CAR-T+ASCT receive conditioning chemotherapy with PBSC reinfusion on day 0 and CAR-T administration (2-4×10⁶/kg) on day +3 (±1). Patients demonstrating Deauville 4-5 or ctDNA positivity at day 28 post-CAR-T infusion subsequently receive four cycles of glofitamab consolidation therapy.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment strategy for people with aggressive B-cell lymphoma (a type of blood cancer) that has come back or stopped responding to prior treatment. It combines bispecific antibodies (drugs that engage the immune system against cancer cells) followed by CAR-T cell therapy (a personalized immune cell treatment), with or without a stem cell transplant. **You may be eligible if...** - You are 18 to 65 years old with relapsed or refractory diffuse large B-cell lymphoma or related aggressive B-cell lymphoma - Your cancer has not responded to, or came back after, at least two prior treatment regimens - Your blood counts and organ function are adequate - Your heart is pumping well (ejection fraction within normal range) **You may NOT be eligible if...** - You have lymphoma primarily in the brain (CNS lymphoma) - You have had a prior bone marrow or stem cell transplant - You have active hepatitis B or C, HIV, or are pregnant or breastfeeding - You have another active cancer (other than certain skin cancers cured more than 5 years ago) 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

DRUGGlofitamab

Glofitamab is administered as monotherapy or in combination with investigator-selected agents (including but not limited to chemotherapy, ADCs, BTK inhibitors, etc.) for 2 cycles.

DRUGChimeric Antigen Receptor T Cells (CAR-T)

After two cycles of glofitamab-based salvage therapy, single-target or dual-target CAR-T cells directed against CD19, CD20, and/or CD22 are infused following lymphodepleting (fludarabine + cyclophosphamide) or myeloablative conditioning, at a dose of 2-4 × 10⁶/kg.

Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

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NCT06996132