CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT

NCT07441291 | Recruiting Phase 3

• 1 other identifier: CD19 CAR-T vs DLI for MRD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT). Patients (aged 3-\<80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI. The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity. The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.

Conditions

B ALL; Allogenetic Hematopoietic Stem Cell Transplantation; MRD-positive

Keywords

CD19 CAR-T; Donor Lymphocyte Infusion (DLI); Ph-negative B-ALL; Minimal Residual Disease (MRD); Hematopoietic Stem Cell Transplantation (HSCT)

Outcome Measures

Primary Outcomes (1)

• 3-month MRD negativity rate

  MRD negativity rate of MFC

  3-month

Secondary Outcomes (7)

• 1-year MRD negativity rate

  1-year

• relapse rate

  1-year

• OS

  1-year

• DFS

  1-year

• GVHD incidence

  1-year

Study Arms (2)

CAR-T group

EXPERIMENTAL

Autologous CD19 CAR-T (1.0×10⁶/kg, single IV infusion) after cyclophosphamide + fludarabine lymphodepletion (no bridging chemo).

Biological: CAR-T

Control group

ACTIVE COMPARATOR

Chemotherapy + DLI

Biological: DLI

Interventions

CAR-T BIOLOGICAL

Autologous CD19 CAR-T cells (1.0×10⁶/kg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg/m²/d ×3d) + fludarabine (30mg/m²/d ×3d); no bridging chemotherapy allowed.

CAR-T group

DLI BIOLOGICAL

Chemotherapy combined with DLI

Control group

Eligibility Criteria

• Age: 3 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• active infections
• uncontrolled graft-versus-host disease (GVHD)
• history of central nervous system disorders
• autoimmune diseases
• other active malignancies

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China, 100044, China

RECRUITING

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Liu, Doctor

CONTACT

8610-88326900; greenimp@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Model Details: Patients were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI. The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity. The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 27, 2026
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)