Study of CD19-directed Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 14, 2024

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2028

Conditions
Acute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia, RefractoryPediatric ALL
Interventions
BIOLOGICAL

CD19-CAR(Mem) T-cells

Allogeneic CD19-CAR.CD45RA-negative T-cells Intravenous infusion

DRUG

Cyclophosphamide

Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.

DRUG

Fludarabine

Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.

DRUG

Mesna

Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide.

DEVICE

CliniMACS

A CliniMACS device is used to select donor T-cells for manufacturing of the memory CAR T-cell product.

PROCEDURE

Leukapheresis

Leukapheresis is performed to collect the T cells that are needed to generate the CD19-CAR.CD45RA-negative T-cells product for the clinic study.

Trial Locations (1)

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER