Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors (SELECT-2CAR)

April 5, 2026 updated by: Beijing Biotech

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biomarker-guided dual-target CAR-T therapy
Participants 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.
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.
Other Names:
  • lymphodepletion
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.
Other Names:
  • lymphodepletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities (DLTs)
Time Frame: 28 Days
28 Days
Incidence and severity of treatment-emergent adverse events
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) by RECIST 1.1 or RANO
Time Frame: 24 Months
24 Months
Disease control rate (DCR)
Time Frame: 24 Months
24 Months
Duration of response (DoR)
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

April 14, 2027

Study Completion (Estimated)

March 17, 2028

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EB-SELECT2CAR-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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