Health Trials

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

ConditionsRelapsed/Refractory B-cell Acute Lymphoblastic LeukemiaRelapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLLRelapsed/Refractory Multiple Myeloma or Plasma Cell LeukemiaRelapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic NeoplasmBPDCN; Relapsed/Refractory T-cell Acute Lymphoblastic LeukemiaT-lymphoblastic LymphomaPeripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech

About this trial

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.

Eligibility criteria

Qualifiers

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/BPDCN; or T-ALL/T-LBL/peripheral T-cell lymphoma.

Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investigator.

Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.

Disqualifiers

- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.

Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the final protocol.

Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved >= Grade 3 toxicity from prior anticancer therapy

Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.

Trial design

Treatments tested in this trial

  • 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
  • Autologous CD33/CLL1 dual-target CAR-T module
  • Autologous CD5/CD7 dual-target CAR-T module

Treatment groups

96 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov