NCT03549442: Phase 1 - CART-BCMA +/- huCART19 as Consolidation High Risk MM

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

Official Title: Phase 1 Study of CART-BCMA With or Without huCART19 as Consolidation of Standard First or Second-Line Therapy for High-Risk Multiple Myeloma

First Posted : June 8, 2018

huCART19: National Cancer Institute

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