Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

PHASE1TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

August 4, 2017

Primary Completion Date

October 10, 2019

Study Completion Date

October 10, 2019

Conditions
Hematopoietic/Lymphoid CancerAcute Myeloid Leukemia
Interventions
PROCEDURE

Leukapheresis

After enrollment, steady state leukapheresis performed to collect apheresis material. The goal is to achieve a target total nucleated cell (TNC) yield of at least 5 x 10\^9 (expected range 5 x 10\^8 - 5 x 10\^10), for up to two days.

DRUG

Fludarabine

25 mg/m2 administered by vein on Days -5 to -3.

DRUG

Cyclophosphamide

900 mg/m2 administered by vein on Day -3.

BIOLOGICAL

CD33-CAR-T Cell Infusion

CD33-CAR-T cell infusion administered by vein on Day 0. First group of participants receive the lowest dose level. Each new group will receive a higher dose than the one before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of T-cells is found. Starting dose level is \> 1.5 x 105/kg but ≤ 4.5 x 105/kg.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Intrexon Corporation

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER