Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)

PHASE1RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

July 18, 2023

Primary Completion Date

July 17, 2026

Study Completion Date

March 29, 2040

Conditions
Leukemia, B-Cell
Interventions
GENETIC

Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy

"Three dose levels will be evaluated with the opportunity to dose de-escalate (dose level -1) for toxicity.~DL-1: 3x10\^6 cells/m2~DL1: 1×10\^7 cells/m2~DL2: 3×10\^7 cells/m2~DL3: 1×10\^8 cells/m2~Lymphodepletion chemotherapy consisting of Fludarabine 30 mg/m2 IV once daily x 4 doses; and Cyclophosphamide 500mg/m2 IV once daily x 2 doses (starting with the first dose of fludarabine)must be completed greater than or equal to 48 hours prior to infusion of CAR-T cells."

Trial Locations (1)

77030

RECRUITING

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Texas Children's Cancer Center

OTHER

lead

Baylor College of Medicine

OTHER