CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Sponsor
Ruijin Hospital
Study ID
NCT06567366
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • CAR T-cell therapy — BIOLOGICAL
    Participants will receive CAR T-cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR T-cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).
  • Glofitamab — DRUG
    Glofitamab is given intravenously at a dose of 2.5mg over 4 hours on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg over 2 hours on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg over 2 hours on Day 1 of Cycles 2-6 (as relevant).
  • Obinutuzumab — DRUG
    Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Study Details

The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.

Key Dates

Start date
Sep 30, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: CAR T-cell therapy in combination with Glofitamab
    After undergoing leukapheresis, participants will receive treatment in the following procedure. Bridging Phase: All participants will receive two cycles of Glofitamab treatment. On Day 1 of Cycle 1, patients will receive 1000 mg of Obinutuzumab as pretreatment. CAR-T Treatment Phase: Participants will receive lymphodepletion therapy with the FLU/CY regimen on Day -5 through Day -3. Participants will receive the CAR T-cell infusion on Day 0. Consolidation Phase: Treatment based on the response assessment at Day 28 after CAR T-cell infusion: participants who attained complete response (CR) at Day 28 will not receive additional Glofitamab treatment, while those attained partial response (PR), stable disease (SD), or progressive disease (PD) will receive additional four cycles of Glofitamab.

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: Up to 2 years ]

Central Contacts

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