CD19 CAR-T versus donor lymphocyte infusion for clearing MRD after allogeneic stem cell transplant in Ph-negative B-ALL
Official title: CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial
Run by Peking University People's Hospital · NCT07441291 · Data updated 2026-11-12
This trial tests whether a single infusion of autologous CD19 CAR-T cells or chemotherapy plus donor lymphocyte infusion better clears minimal residual disease in patients aged 3–79 with Ph-negative B‑cell ALL after allogeneic stem cell transplant.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 79 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, chimeric antigen receptor, cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, China) |
| Status | Recruiting |
| Started | November 30, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2028 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07441291 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 3 to <80 years with Ph-negative B-ALL who are MRD-positive (≥0.1% CD19+ abnormal B cells) after allogeneic HSCT, have ECOG 0–2, adequate organ function, and no active infection or uncontrolled GVHD.
✕Probably not a fit
Patients with active infections, uncontrolled graft‑versus‑host disease, central nervous system disorders, autoimmune disease, other active malignancies, or overt hematologic/extramedullary relapse are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, randomized phase 3 trial enrolling 70 patients with Ph-negative B-ALL who are MRD-positive (≥0.1% CD19+ abnormal B cells) after allogeneic HSCT and have ECOG 0–2 and adequate organ function. Participants are randomized 1:1 to receive either autologous CD19 CAR-T cells (1.0×10^6/kg) after cyclophosphamide+fludarabine lymphodepletion or conventional chemotherapy combined with donor lymphocyte infusion (DLI). The primary endpoint is MRD negativity at 3 months, with planned secondary endpoints including 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD‑free relapse‑free survival, and duration of severe hematologic toxicity. Follow-up is conducted up to one year after last treatment, and crossover to the alternative treatment is permitted for patients with persistent MRD at 3 months in the absence of relapse.
Why it matters
Potential benefit: If successful, the CAR-T approach could increase MRD clearance after transplant and lower relapse risk, potentially improving disease-free and overall survival.
How similar studies have gone: CD19 CAR-T therapies have produced high remission rates in relapsed or refractory B-ALL, but randomized comparisons versus chemotherapy plus DLI specifically for post‑HSCT MRD are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 3-\<80 years * ECOG performance status 0-2 * post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry) * no hematological/extramedullary relapse * adequate organ function * negative pregnancy test (for fertile females) Exclusion Criteria: * active infections * uncontrolled graft-versus-host disease (GVHD) * history of central nervous system disorders * autoimmune diseases * other active malignancies
Where it's running
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Peking University People's Hospital
Beijing, China, China Recruiting
Study contacts
- Study coordinator: Jing Liu, Doctor
- Email: greenimp@163.com
- Phone: 8610-88326900
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.