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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06996132
Phase
PHASE2
Status
Recruiting
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Conditions

  • Relapsed or Refractory Aggressive B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    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.
  • Chimeric Antigen Receptor T Cells (CAR-T) — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 9, 2025
Status verified
May 2025
Primary completion
May 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab-based therapy followed by CAR-T ± ASCT
    Subjects will receive two cycles of glofitamab-based therapy, followed by either CAR-T cell therapy alone or in combination with ASCT.

Primary Outcome Measure

complete response rate after CAR-T±ASCT [ Time Frame: From CAR-T±ASCT administration until 1 year post-treatment ]

Central Contacts