• Active, not recruiting

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

Updated: May 26

RRMM


huCART19

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


CART-BCMA: National Cancer Institute

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

 

Cyclophosphamide : National Cancer Institute

Cyclophosphamide : MedlinePlus Drug Information


Fludarabine : National Cancer Institute

Fludarabine : MedlinePlus Drug Information


 

Location

United States, Pennsylvania


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