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Also known as JCAR017 (lisocabtagene maraleucel) single-dose schedule
JCAR017 single-dose schedule · 1 trial · 5 indications
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Lugano criteria
| Arm | Type | Description |
|---|---|---|
| JCAR017 1-dose schedule | EXPERIMENTAL | Each cycle of JCAR017 (lisocabtagene maraleucel) will be administered as 1 intravenous (IV) injection |
| JCAR017 2-dose schedule (no longer accruing) | EXPERIMENTAL | Each cycle of JCAR017 (lisocabtagene maraleucel) will be administered as 2 intravenous (IV) injections |
| Name | Type | Description |
|---|---|---|
| JCAR017 (lisocabtagene maraleucel) single-dose schedule | BIOLOGICAL | Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection. |
| JCAR017 (lisocabtagene maraleucel) 2-dose schedule | BIOLOGICAL | Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon product availability, participants will receive study treatment consisting of lymphodepleting chemotherapy followed by two IV doses of JCAR017. |
Inclusion Criteria: 1. Age ≥18 years 2. Relapsed or refractory B-cell NHL, including 1. DLBCL cohort (no longer enrolling): DLBCL, not otherwise specified (NOS; includes transformed DLBCL from indolent histology \[tDLBCL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement...
JCAR017 single-dose schedule is being studied in non-Hodgkin lymphoma, including diffuse large B cell lymphoma, follicular lymphoma, mantle-cell lymphoma, and primary mediastinal B-cell lymphoma. It is a CAR-T therapy developed by Bristol-Myers Squibb. The single-dose schedule refers to administering the therapy as one dose rather than a divided dosing regimen.
JCAR017 single-dose schedule is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical program evaluating this CAR-T therapy in B-cell non-Hodgkin lymphoma.
JCAR017 single-dose schedule is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 trial, TRANSCEND-NHL-001, has been completed. The program enrolled 387 participants and evaluated the safety and pharmacokinetics of the therapy in B-cell non-Hodgkin lymphoma.
JCAR017 single-dose schedule was evaluated in the Phase 1 TRANSCEND-NHL-001 trial, registered as NCT02631044. The trial studied the safety and pharmacokinetics of JCAR017 in B-cell non-Hodgkin lymphoma, including diffuse large B cell lymphoma, follicular lymphoma, mantle-cell lymphoma, and primary mediastinal B-cell lymphoma. It enrolled 387 participants in the United States and has been completed.
Yes, JCAR017 single-dose schedule is also known as JCAR017 (lisocabtagene maraleucel) single-dose schedule. Lisocabtagene maraleucel is the international nonproprietary name for the CAR-T therapy referred to as JCAR017. The single-dose schedule designation distinguishes this dosing approach from other schedules studied for the same therapy.