Addition of Nivolumab to Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive DLBCL at Lymphodepletion

Sponsor
Tel-Aviv Sourasky Medical Center
Study ID
NCT05385263
Phase
PHASE2
Status
Unknown

Conditions

  • B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Nivolumab Injection [Opdivo] — DRUG
    Nivolumab ( 3mg/kg IV) on day +5. If CAR-T expansion\<100 cells/microL on day +7 one additional dose of nivolumab (3mg/kg IV) will be given on day +19

Study Details

Progression of DLBCL is the major obstacle for the success of chimeric antigen receptor-T cell (CAR-T) with approximately 60% of the patients relapsing in the first year, and 40% within 3 months, after infusion. While patient with DLBCL in Partial Response/Complete Response at lymphodepletion have a 1-year Progression Free Survival (PFS) of 60-80%, those with Stable Disease/Progressive Disease at time of lymphodepletion have a dismal PFS of 20-30%. Trials showed that better expansion of CAR-T cells, even in patients with a progressive disease, may overcome this grave prognosis and may result in better PFS

Key Dates

Start date
May 11, 2022
Status verified
Apr 2022
Primary completion
Apr 30, 2024
Completion
Oct 31, 2024

Study Design

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

Arms

  • Experimental: NIVOLUMAB
    All patients enrolled will be given nivolumab ( 3mg/kg IV) on day +5 Patients with CAR-T expansion\<100 cells/microL on day +7 will be given 1 additional dose of nivolumab (3mg/kg IV) on day +19 (two weeks after first dose of nivolumab).

Primary Outcome Measure

Overall response at 1 months after CAR-T infusion [ Time Frame: One month post CAR-T infusion ]

Central Contacts

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