Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
SELECT-2CAR
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
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2026
CompletedFirst Submitted
Initial submission to the registry
April 5, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 17, 2028
April 13, 2026
April 1, 2026
1.1 years
April 5, 2026
April 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicities (DLTs)
28 Days
Incidence and severity of treatment-emergent adverse events
12 Months
Secondary Outcomes (3)
Objective response rate (ORR) by RECIST 1.1 or RANO
24 Months
Disease control rate (DCR)
24 Months
Duration of response (DoR)
24 Months
Study Arms (1)
Biomarker-guided dual-target CAR-T therapy
EXPERIMENTALParticipants undergo central antigen-pair screening and receive the bestmatched autologous dual-target CAR-T construct from the predefined library after lymphodepletion with fludarabine / cyclophosphamide. A second infusion may be permitted in selected participants if product is available, the assigned dose level remains safe, and retreatment criteria are met.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- ECOG performance status 0-1 (CNS cohort may allow Karnofsky \>= 70 or ECOG 0-2 if justified).
- Adequate organ function: ANC \>= 1.0 x 10\^9/L, platelets \>= 75 x 10\^9/L, hemoglobin \>= 8 g/dL, creatinine clearance \>= 50 mL/min, AST / ALT \<= 3 x ULN (\<= 5 x ULN if liver involvement), total bilirubin \<= 1.5 x ULN unless Gilbert syndrome, LVEF \>= 45%, oxygen saturation \>= 92% on room air.
- Recovered to Grade \<= 1 from acute toxicities of prior anticancer therapy (except alopecia, stable endocrinopathies, or other protocol-allowed residual toxicities).
- Adequate venous access and ability to undergo leukapheresis; successful manufacture of a release-qualified autologous dual-target CAR-T product.
- Life expectancy \>= 12 weeks.
- Negative pregnancy test for persons of childbearing potential and agreement to use highly effective contraception per protocol.
- Ability to understand and sign informed consent and comply with study follow-up, including long-term gene-modified cell monitoring.
You may not qualify if:
- 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.
- Active autoimmune disease requiring systemic immunosuppression within the past 2 years, except protocol-allowed stable conditions.
- Clinically significant cardiovascular disease (for example uncontrolled arrhythmia, recent myocardial infarction, unstable angina, decompensated heart failure), severe pulmonary compromise, or other major comorbidity making cell therapy unsafe.
- Active symptomatic CNS hemorrhage, uncontrolled seizures, or uncontrolled intracranial hypertension; leptomeningeal disease requiring urgent intervention unless explicitly allowed in a CNS-specific cohort.
- Pregnancy or breastfeeding.
- Concurrent second malignancy requiring active systemic treatment, except certain low-risk or definitively treated cancers allowed by protocol.
- Any condition that, in the investigator's judgment, would interfere with safe participation, product manufacture, infusion, or interpretation of results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Biotechlead
Study Sites (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Not masked because construct selection, manufacturing release, doseescalation decisions, and acute cell-therapy toxicity monitoring require investigator awareness.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2026
First Posted
April 13, 2026
Study Start
March 2, 2026
Primary Completion (Estimated)
April 14, 2027
Study Completion (Estimated)
March 17, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04