Glofitamab Combined With CAR-T Therapy in R/R DLBCL

Sponsor
Ruijin Hospital
Study ID
NCT07326371
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.
  • Obinutuzumab — DRUG
    Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
  • Axicabtagene Ciloleucel — DRUG
    Axicabtagene Ciloleucel IV infusion will be administered as per the schedule specified in the respective arm.
  • Relmacabtagene autoleucel (relma-cel) — DRUG
    Relmacabtagene autoleucel IV infusion will be administered as per the schedule specified in the respective arm.

Study Details

This study is a single-center, open-label, prospective study aimed at evaluating the efficacy and safety of Glofitamab combined with CAR-T therapy in patients with high-risk relapsed/refractory large B-cell lymphoma.

Key Dates

Start date
Mar 31, 2026
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Mar 31, 2029

Study Design

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

Arms

  • Experimental: Glofit_CART
    After undergoing leukapheresis, patients will receive treatment in three phases: the bridging phase, the CAR-T treatment phase, and the consolidation phase. Bridging Phase: All patients will receive two cycles of Glofitamab treatment. On Day 1 of Cycle 1, patients will receive 1000 mg of Obinutuzumab as pretreatment. After the completion of Cycle 2, patients will undergo an assessment. CAR-T Treatment Phase: Participants will receive lymphodepletion therapy with the FLU/CY regimen from Day -5 to Day -3. On Day 0, patients will receive the CAR-T cell infusion. Consolidation Phase: Based on the efficacy assessment on Day 28, the subsequent treatment plan will be determined: Patients achieving complete response (CR) will not receive additional Glofitamab treatment. Patients with partial response (PR), stable disease (SD), or progressive disease (PD) will continue to receive Glofitamab treatment for four additional cycles.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: Baseline up to the end of treatment (EOT) (approximately 4 months) ]

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