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

Launched by RUIJIN HOSPITAL · Jul 24, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment approach for people with hard-to-treat or returning acute leukemia, a type of blood cancer. After receiving a special type of therapy called CAR-T, which helps the immune system target cancer cells, many patients still face the risk of the cancer coming back within a year. This trial combines CAR-T therapy with a type of stem cell transplant from a partially matched donor, where certain immune cells are removed to reduce side effects. Additionally, it includes a preventive infusion of memory T cells—these are immune cells that "remember" infections and cancer—to help protect against relapse and infections while lowering the risk of complications like graft-versus-host disease, a condition where transplanted cells attack the body.

People who might be eligible for this trial are those with relapsed or refractory acute leukemia who have no fully matched donor available for transplant. Eligible participants should have responded well enough to prior CAR-T therapy, with no active disease detected in their bone marrow or other parts of the body, and have good overall organ health. If accepted into the study, participants can expect to undergo the combined treatment involving stem cell transplant and memory T-cell infusion, with close monitoring to evaluate the safety and effectiveness of this new approach. This trial aims to find better ways to keep leukemia in remission and improve long-term outcomes for patients with difficult-to-treat blood cancers.

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosis: Patients with refractory or relapsed (R/R) leukemia.
• • Donor Availability: No matched sibling or unrelated donor identified through HLA typing.
• • Disease Status Post-CAR-T: including achieved complete remission (CR), minimal residual disease (MRD)-negative in bone marrow and no extramedullary relapse.
• • Normal Organ Function (meeting the following criteria): including liver function: ALT/AST ≤10×ULN (upper limit of normal), total bilirubin (TBIL) ≤5×ULN, renal function: BUN and serum creatinine (Cr) ≤1.25×ULN and cardiac function: No evidence of cardiac insufficiency (confirmed by ECG and echocardiography).
• • Informed Consent: a signed informed consent form (ICF) is obtained
• Exclusion Criteria:
• • Presence of any absolute contraindication to hematopoietic stem cell transplantation.
• • Severe Comorbidities with Major Organ Dysfunction