Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

March 22, 2012

Primary Completion Date

December 12, 2025

Study Completion Date

August 12, 2040

Conditions
Acute Lymphoblastic LeukemiaImmune System DiseasesImmunoproliferative Disorders
Interventions
BIOLOGICAL

iC9-CAR19 cells

Three dose levels are being evaluated: dose level -1 (1 x 10\^5), dose level 1 (5 x 10\^5), and dose level 2 ( 1x 10\^6)

DRUG

Rimiducid

Subjects with CRS and ICAN will assign one of two dose levels (DL)s of rimiducid with the standard treatment: 0.05 mg/kg or 0.1 mg/kg for subjects with CRS and 0.01mg/kg or 0.1mg/kg for subjects with ICAN. Subjects will first be enrolled on DL 1 and then enrolled on DL 2, and 0.4mg/kg rimiducid will be given to subjects who did not respond to the initial dose.

DRUG

Cyclophosphamide

900 mg/m\^2 IV over 1 hour on day 4 of lymphodepleting chemotherapy.

DRUG

Fludarabine

25 mg/m\^2/day IV over 30 minutes administered for 3 consecutive days.

Trial Locations (1)

27599

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bellicum Pharmaceuticals

INDUSTRY

collaborator

The Leukemia and Lymphoma Society

OTHER

lead

UNC Lineberger Comprehensive Cancer Center

OTHER