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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors (NCT07523529) is a Phase 1 / Phase 2 interventional studying Advanced Unresectable and Metastatic, sponsored by Beijing Biotech. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Unresectable, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 72 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Unresectable subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18-75 years at consent - diagnosed by tissue sample (biopsy-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. - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1 (CNS cohort may allow Karnofsky \>= 70 or ECOG 0-2 if justified). - your organs (liver, kidneys, etc.) are working well enough based on blood tests: 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 willing to sign a consent form and comply with study follow-up, including long-term gene-modified cell monitoring. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University Shenzhen Hospital
Shenzhen, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07523529), the sponsor (Beijing Biotech), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07523529 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07523529?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07523529?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07523529. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07523529. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.