Donor stem cell transplant after CAR-T therapy for acute leukemia
Tests a donor stem cell transplant after CAR-T in adults with acute leukemia.
Plain-language title generated from the registry record
Registry title: Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose leukemia came back or did not respond to treatment. They must have had CAR-T therapy and have no matched donor.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Leukemia that came back or did not respond to treatment. After CAR-T therapy, complete remission, no leukemia cells found in the bone marrow (MRD-negative), and no relapse outside the bone marrow.
- Earlier treatment
- Must have had CAR-T therapy. No matched sibling or unrelated donor found by HLA typing.
Main reasons for not taking part
- Any absolute reason against stem cell transplantation
- Severe other illness with major organ damage
- Poor liver, kidney or heart function
Read by machine on 12 November 2026.
Where in China
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaContact: Dr. Jiang, PhD, Medical DegreeNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07087847
- Record updated
- 28 July 2025
- Original description
CAR-T therapy has evolved as a pivotal treatment for relapsed/refractory (R/R) leukemia, demonstrating improved remission rates and manageable adverse events. However, over 50% of patients achieving complete remission (CR) experience relapse within one year (1-year cumulative incidence rate, CIR) due to antigen escape, CAR-T functional exhaustion, premature cell depletion, and immunosuppressive microenvironments. Novel strategies are urgently needed to sustain durable responses.Read full original descriptionShow less
Prospective, Single-Center, Single-Arm Clinical Study of Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia
CAR-T therapy has evolved as a pivotal treatment for relapsed/refractory (R/R) leukemia, demonstrating improved remission rates and manageable adverse events. However, over 50% of patients achieving complete remission (CR) experience relapse within one year (1-year cumulative incidence rate, CIR) due to antigen escape, CAR-T functional exhaustion, premature cell depletion, and immunosuppressive microenvironments. Novel strategies are urgently needed to sustain durable responses.
Bridging CAR-T therapy with TCRαβ+ and CD45RA+ cell-depleted haploidentical hematopoietic stem cell transplantation (HSCT) offers dual benefits: Graft-versus-leukemia (GvL) effects mediated by donor-derived NK cells and γδT cells target non-CAR-dependent antigens, mitigating immune evasion. Rapid hematopoietic reconstitution reduces prolonged cytopenia-related complications from prior therapies. This protocol further incorporates prophylactic CD45RO+ memory T-cell (Tm) infusion to: Minimize graft-versus-host disease (GVHD) risks compared to conventional donor lymphocyte infusion (DLI). Enhance adoptive immunity against infections/relapse via transferred donor memory immunity. We design this prospective, single-center, single-arm trial to evaluate the efficacy/safety of this approach using the CliniMACS® system for ex vivo TCRαβ+/CD45RA+ depletion in R/R leukemia patients post-CAR-T.
Inclusion: 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: Presence of any absolute contraindication to hematopoietic stem cell transplantation; Severe Comorbidities with Major Organ Dysfunction.