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

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

Trial Details

NCT ID

NCT07523555

Phase

PHASE1 / PHASE2

Sponsor

Beijing Biotech

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Autologous CD19/CD22 dual-target CAR-T module
Autologous CD19/CD20 dual-target CAR-T module
Autologous BCMA/CD19 dual-target CAR-T module
Autologous BCMA/CD38 dual-target CAR-T module
Autologous BCMA/GPRC5D dual-target CAR-T
Autologous CD33/CD123 dual-target CAR-T module

Locations (sample)

Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

Age 18 to 75 years at the time of consent.
Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk MDS/BPD…
Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investiga…
Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety re…

For full eligibility, visit ClinicalTrials.gov.

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