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Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies

NCT07523555 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-13

No results posted yet for this study

Summary

Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response.

Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.

Conditions

  • Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
  • Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
  • Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
  • Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm
  • BPDCN; Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
  • T-lymphoblastic Lymphoma
  • Peripheral T-cell Lymphoma

Interventions

BIOLOGICAL

Autologous CD19/CD22 dual-target CAR-T module

Biological: Autologous CD19/CD22 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.

BIOLOGICAL

Autologous CD19/CD20 dual-target CAR-T module

Biological: Autologous CD19/CD20 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.

BIOLOGICAL

Autologous BCMA/CD19 dual-target CAR-T module

Biological: Autologous BCMA/CD19 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.

BIOLOGICAL

Autologous BCMA/CD38 dual-target CAR-T module

Biological: Autologous BCMA/CD38 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.

BIOLOGICAL

Autologous BCMA/GPRC5D dual-target CAR-T

Biological: Autologous BCMA/GPRC5D dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide

BIOLOGICAL

Autologous CD33/CD123 dual-target CAR-T module

Biological: Autologous CD33/CD123 dual-target CAR-T module (simultaneous or planned sequential paired infusion, module-specific) after lymphodepletion.

BIOLOGICAL

Autologous CD33/CLL1 dual-target CAR-T module

Biological: Autologous CD33/CLL1 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.

BIOLOGICAL

Autologous CD5/CD7 dual-target CAR-T module

Biological: Autologous CD5/CD7 dual-target CAR-T module (including sequential paired infusion if needed for manufacturing/safety) after lymphodepletion.

Sponsors & Collaborators

  • Beijing Biotech

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2027-03-14
Completion
2028-02-17

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 NCT07523555 on ClinicalTrials.gov