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Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL

NCT06880913 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-30

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL

Conditions

  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

BIOLOGICAL

Nanobody-Based CD19/CD22 Tandem Dual CAR-T

Phase I: Patients will receive a single infusion of autologous CD19/CD22 dual CAR-T cells at one of three dose levels (0.3 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine (25-30mg/m2\*3d) and cyclophosphamide (250-300mg/m2\*3d) (FC) lymphodepleting chemotherapy. Phase II: Patients will receive autologous CD19/CD22 dual CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.

Sponsors & Collaborators

  • Hebei Senlang Biotechnology Inc., Ltd.

    collaborator INDUSTRY

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiao-jun Huang, MD · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880913 on ClinicalTrials.gov