NCT07523529

Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors

A Phase 1/2, Open-Label, Biomarker-Guided Master Protocol Evaluating Autologous Dual-Target CAR-T Cells Selected From a Predefined Target Library in Adults With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Beijing Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase 1/2 master protocol evaluating autologous dual-target CAR-T cell therapy in adults with advanced solid cancers. After central biomarker screening, each participant is assigned the best-matched dual-target construct from a predefined target-pair library. The trial is designed to test whether biomarkerguided dual targeting can improve tumor control, reduce antigenescape risk, and preserve safety in solid tumors.

Detailed description

Participants undergo central pathology review and antigen profiling on fresh or archived tumor tissue. If one or more predefined dual-target pairs qualify, a target-selection committee ranks candidate pairs using (1) co-expression level, (2) tumor-normal differential, (3) diseasespecific biologic rationale, and (4) product / manufacturing feasibility. All enrolled participants receive lymphodepletion with fludarabine and cyclophosphamide followed by one infusion of the assigned autologous dual-target CAR-T product. Each newly activated target-pair cohort begins with dose escalation (modified 3+3 lead-in) and, if acceptable, proceeds to dose expansion at the recommended Phase 2 dose / schedule (RP2D / RP2S). Optional repeat infusion is allowed for selected participants with retained eligibility, available product, and no prohibitive toxicity. Disease response is assessed by RECIST 1.1 for non-CNS disease and by RANO for CNS cohorts. Participants are followed for disease outcomes for 24 months and for long-term genemodified cell safety for up to 15 years, consistent with local genetherapy follow-up expectations. Because the solid-tumor target landscape continues to evolve, this example uses a broad predefined target library rather than claiming to be a permanently exhaustive list of every future target.

Conditions

• Advanced Unresectable
• Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	Autologous dual-target CAR-T cells selected from the predefined target library.	Autologous dual-target CAR-T cells are patient-derived T cells engineered to recognize two tumor-associated antigens selected from a predefined target library. In clinical trials, they are administered to enhance tumor targeting and reduce antigen escape, with evaluation of safety, tolerability, and preliminary anti-tumor activity.
DRUG	Fludarabine	chemotherapy preconditioning regimen used before cell therapy to reduce the patient's existing lymphocytes and create space for infused cells. In clinical trials, it is given prior to CAR-T infusion to enhance cell expansion, persistence, and overall treatment efficacy.
DRUG	Cyclophosphamide	Cyclophosphamide lymphodepletion is a chemotherapy preconditioning regimen administered prior to cell therapy to suppress existing immune cells and improve the environment for infused cells. In clinical trials, it is given before CAR-T infusion to support cell expansion, persistence, and enhance therapeutic effectiveness.

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-04-14
• Completion: 2028-03-17
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China