NCT03549442: Phase 1 - CART-BCMA +/- huCART19 as Consolidation High Risk MM
- Active, not recruiting
- Dec 27, 2018
- 1 min read
Updated: May 26, 2022
RRMM
Phase A: 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 A Expansion: To occur once safety is demonstrated in Phase A.
Phase B: 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-dose infusions after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.
Phase C: 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.
ClinicalTrials.gov Identifier: NCT03549442
First Posted : June 8, 2018
autologous anti-CD19 CAR TCR-zeta/4-1BB-transduced T lymphocytes huCART19
anti-CD19 CAR-T cells huCART19
anti-CD19 Humanized scFv TCRz-41BB-CAR lentiviral vector-transduced autologous T lymphocytes
autologous anti-CD19 CAR-CD3zeta-4-1BB-expressing T cells huCART19
CTL119
CTL119 cells
huCART19 cells
huCART19 T lymphocytes
autologous anti-BCMA-CAR-TCRz/4-1BB-expressing T lymphocytes CART-BCMA
autologous BCMA 4-1BBz CAR T cells CART-BCMA
autologous BCMA-specific CAR-TCRz/4-1BB-expressing T lymphocytes CART-BCMA
CART-BCMA cells
CART-BCMA
Location
United States, Pennsylvania
