Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia

NANot yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

January 30, 2028

Study Completion Date

September 30, 2028

Conditions
Acute LeukemiaAcute Leukemia RefractoryAcute Myeloid Leukemia (AML)ALL (Acute B-Lymphoblastic Leukemia)Acute Leukemia in Relapse
Interventions
BIOLOGICAL

TCRαβ+/CD45RA+depleted haploidentical hematopoietic stem cell transplantation (haplo-HSCT)

Approximately 28 days post-CAR-T therapy, a hematologic assessment will be performed. Eligible patients meeting the inclusion criteria will subsequently undergo TCRαβ+/CD45RA+depleted haploidentical hematopoietic stem cell transplantation (haplo-HSCT).Collect peripheral blood stem cells (PBSC) from the haplo-donor.Split the graft into two fractions at a 9:1 ratio, 90% fraction: subject to TCRαβ+ T-cell depletion, 10% fraction: subject to CD45RA+ T-cell depletion. Primary graft (TCRαβ+depleted and partial CD45RA+ depleted): Freshly infused into the recipient. Residual CD45RA-depleted lymphocytes: Cryopreserved for prophylactic donor lymphocyte infusion (DLI) as needed.

Trial Locations (1)

200025

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
collaborator

Miltenyi Biotec B.V. & Co. KG

INDUSTRY

lead

Ruijin Hospital

OTHER

NCT07087847 - Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia | Biotech Hunter | Biotech Hunter