Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-75 years at consent
Histologically or cytologically confirmed advanced unresectable, metastatic, or recurrent solid malignancy (including recurrent high-grade glioma for CNSspecific pairs) for which standard curative therapy does not exist, is not tolerated, or has failed.
At least one predefined dual-target pair qualifies on central biomarker review. Recommended working thresholds: primary antigen >= 2+ intensity in >= 50% of viable tumor cells (or pair-specific equivalent) AND secondary antigen detectable in >= 25% of viable tumor cells, with acceptable normal-tissue risk after pathology review
At least 1 measurable lesion by RECIST 1.1, or measurable / evaluable disease by RANO for CNS cohorts.
Disqualifiers
No qualifying target pair after central review, or target pair considered unsafe because of unacceptable predicted ontarget / off-tumor risk.
Prior gene-modified cellular therapy directed against the same target pair within 6 months, or persistent clinically significant toxicity from prior cell / gene therapy.
Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection; active tuberculosis; uncontrolled HIV; active hepatitis B or C with detectable / unsafe viral burden.
Need for systemic corticosteroids > 10 mg prednisone equivalent daily or other systemic immunosuppressive therapy within 7 days before lymphodepletion, unless specifically allowed for physiologic replacement or CNS edema management per cohort rules.
Trial design
Treatments tested in this trial
- Autologous dual-target CAR-T cells selected from the predefined target library.
- Fludarabine
- Cyclophosphamide
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov