Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

October 28, 2025

Primary Completion Date

November 1, 2030

Study Completion Date

October 1, 2034

Conditions
Hematologic MalignanciesHematologic Neoplasms
Interventions
BIOLOGICAL

mCD19-CAR-CD28-CD3-zeta.(anti-CD19 CAR) retroviral vector-transduced allogeneic peripheral blood lymphocytes (PBL)

CAR-T cell infusion given at four escalating dose levels (DL1: 3 x 10\^4 cells/kg, DL2: 1 x 10\^5 cells/kg, DL3: 3 x 10\^5 cells/kg, DL4: 1 x 10\^6 cells/kg) with a dose de-escalation dose (DL-1: 1 x 10\^4 cells/kg), if needed.

DRUG

Fludarabine

Pre-transplant: 30 mg/m\^2 IV infusion over 30-60 minutes once daily for 5 days from day -6 through day -2

DRUG

Cyclophosphamide

"Pre-transplant: 14.5 mg/kg/day IV daily for 2 days pre-transplant on day -6 and day -5.~Post-transplant: 25 mg/kg/day on day +3 and day +4."

DRUG

Mycophenolate Mofetil

15 mg/kg orally or IV three times daily (max 1000 mg/dose) starting on day +5, continued through day +35 post-transplant.

DRUG

Sirolimus

Loading dose of 6 mg orally given on day +5, then maintenance dose starting at 2 mg orally daily on day +6 with dose adjustments to maintain a trough of 5-12 ng/ml, continued through day +60 post-transplant.

DEVICE

CD19 Flow Cytometry Assay

Assay used to determine CD19+ status

DEVICE

CD19 Immunohistochemical Assay

Assay used to determine CD19+ status

RADIATION

Total Body Irradiation

400 centigray (cGy) to be delivered in 2 fractions as 200 cGy per fraction twice a day on Day -1 pre-transplant.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH