Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BCMA CART+ huCART19 · 1 trial · 1 indication
The occurrence of adverse events that are possibly, probably or definitely related to CAR T cells.
| Arm | Type | Description |
|---|---|---|
| Phase A | EXPERIMENTAL | Safety Run-in to test the safety of CART-BCMA + huCART19 as split-dose infusions after lymphodepleting chemotherapy with cyclophosphamide + fludarabine in patients who have relapsed/refractory myeloma after two prior regimens but who are responding to their current therapy. |
| Phase B | EXPERIMENTAL | Randomization Phase in which patients responding to first or second-line therapy will receive either CART-BCMA alone (Cohort 1) or CART-BCMA + huCART19 (Cohort 2) as split-doses after lymphodepleting chemotherapy with cyclophosphamide + fludarabine. |
| Phase C | EXPERIMENTAL | Single-dose infusion phase to test the safety of single-dose infusion of CART-BCMA alone (Cohort 1) and CART-BCMA + huCART19 (Cohort 2) as single-dose infusions after lymphodepleting chemotherapy with cyclophosphamide + fludarabine in patients responding to first- or second-line therapy. |
| Phase A Expansion | EXPERIMENTAL | Once safety of CART-BCMA/huCART19 combination therapy is established in Phase A, an expansion of Phase A will occur in which the Phase A target population (patients with relapsed/refractory multiple myeloma responding to a standard salvage therapy regimen) will receive both CART-BCMA and huCART19. Enrollment into the Phase A Expansion may occur concurrently with Phase B once opened. |
| Name | Type | Description |
|---|---|---|
| BCMA CART + huCART19 | BIOLOGICAL | The target dose for CART-BCMA and huCART19 will be 5x10\^8 CAR-expressing cell for each product. Split dose infusions will consist of a 10% dose (of one or both products) on the first infusion day, 30% dose (of one or both products) on the second infusion day, or 60% dose (of one or both products) on the third infusion day. Infusion days may be spread over 7 calendar days due to scheduling constraints or to allow observation of suspected early cytokine release syndrome or other toxicity. Infusions will begin 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy with cyclophosphamide + fludarabine. |
| CART BCMA or CART BCMA + huCART19 | BIOLOGICAL | The target dose for CART-BCMA and huCART19 will be 5x10\^8 CAR-expressing cell for each product. Cohort 1 refers to the group of subjects assigned to receive CART-BCMA alone; Cohort 2 refers to the group of subjects assigned to receive CART-BCMA + huCART19. Split dose infusions will consist of a 10% dose (of one or both products) on the first infusion day, 30% dose (of one or both products) on the second infusion day, or 60% dose (of one or both products) on the third infusion day. Infusion days may be spread over 7 calendar days due to scheduling constraints or to allow observation of suspected early cytokine release syndrome or other toxicity. Infusions will begin 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy with cyclophosphamide + fludarabine. |
| Single-dose infusion of CART BCMA or CART BCMA + huCART19 | BIOLOGICAL | The target dose for CART-BCMA and huCART19 will be 5x10\^8 CAR-expressing cell for each product. Cohort 1 refers to the group of subjects assigned to receive single dose infusions of CART-BCMA alone; Cohort 2 refers to the group of subjects assigned to receive single dose infusions of CART-BCMA + huCART19. Infusions will begin 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy with cyclophosphamide + fludarabine. |
Inclusion Criteria: 1. Subjects must have a diagnosis of multiple myeloma according to IMWG 2014 criteria106 with any of the following high-risk features. Subjects in the Phase A Expansion are not required to have any high-risk features. 1. Beta-2-microglobulin ≥ 5.5 mg/L and LDH greater than u...
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BCMA CART+ huCART19 is an investigational combination therapy being studied for the treatment of multiple myeloma. It combines two chimeric antigen receptor T-cell therapies, BCMA CART and huCART19, and is being evaluated in patients with high-risk multiple myeloma. The therapy is currently in Phase 1 clinical development.
BCMA CART+ huCART19 is being developed by Novartis AG, a global healthcare company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy in patients with multiple myeloma.
BCMA CART+ huCART19 is currently in Phase 1 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The therapy is being studied in an active clinical trial for high-risk multiple myeloma, and its safety and effectiveness are still being evaluated.
BCMA CART+ huCART19 is being studied in a Phase 1 clinical trial with the identifier NCT03549442. The trial is titled "Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma" and is active but not recruiting participants. The study is enrolling 40 patients in the United States and is open to adults aged 18 years and older.
Yes, BCMA CART+ huCART19 is the same as BCMA CART + huCART19. The two names refer to the identical combination therapy, which pairs a BCMA-targeted CAR T-cell therapy with a CD19-targeted huCART19 therapy. This naming variation is used interchangeably in clinical trial documentation and research contexts.