Advanced UnresectablePhase 1/2SELECT-2CARNCT07523529
Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
A Phase 1/2 study testing Autologous dual-target CAR-T cells selected from the predefined target library., Fludarabine and Cyclophosphamide in people with Advanced Unresectable and Metastatic, run by Beijing Biotech at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Unresectable, Metastatic
- What is being tested?
- Autologous dual-target CAR-T cells selected from the predefined target library., Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 17 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: 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.
Read the 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
- Being tested
- Autologous dual-target CAR-T cells selected from the predefined target library., Fludarabine, Cyclophosphamide
- Keywords
- antigen co-expression, B7-H3, bi-specific CAR-T, biomarkerguided, CD133, CD44, CD56, CD70, CLDN18.2, dual-target CAR-T, EGFR, EGFRvIII, GD2, gastric cancer, glioblastoma, GPC3, HER2, hepatocellular carcinoma, IL13Ralpha2, Mesothelin
- Medical subject headings
- Neoplasm Metastasis, Stomach Neoplasms, Glioblastoma, Carcinoma, Hepatocellular, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dual-target CAR-T cells selected from the predefined target library.Biological
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.
FludarabineDrug
Also called lymphodepletion
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.
CyclophosphamideDrug
Also called lymphodepletion
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.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker-guided dual-target CAR-T therapy | Experimental | 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. Receives: Biological: Autologous dual-target CAR-T cells selected from the predefined target library.; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Measured: 28 Days
Incidence and severity of treatment-emergent adverse events
Measured: 12 Months
Secondary outcomes (3)
Objective response rate (ORR) by RECIST 1.1 or RANO
Measured: 24 Months
Disease control rate (DCR)
Measured: 24 Months
Duration of response (DoR)
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Mar 2026
- Primary completion14 Apr 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced UnresectableStudies of the same condition, open and under way.
- More trials run by Beijing BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group biomarker-guided master protocol. Every participant follows the same treatment strategy: screen for target-pair eligibility, assign the highest-ranked dual-target construct from the predefined library, administer standard lymphodepletion, then infuse the selected CAR-T product. Pair-specific dose escalation and expansion occur as subcohorts within the master protocol, but the overall study remains one non-randomized treatment strategy.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523529
- Sponsor's protocol ID
- EB-SELECT2CAR-002
- Acronym
- SELECT-2CAR
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07523529
- Acronym / sponsor ID
- SELECT-2CAR / EB-SELECT2CAR-002
- Conditions
- Advanced Unresectable, Metastatic
- Keywords
- antigen co-expression, B7-H3, bi-specific CAR-T, biomarkerguided, CD133, CD44, CD56, CD70
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group biomarker-guided master protocol. Every participant follows the same treatment strategy: screen for target-pair eligibility, assign the highest-ranked dual-target construct from the predefined library, administer standard lymphodepletion, then infuse the selected CAR-T product. Pair-specific dose escalation and expansion occur as subcohorts within the master protocol, but the overall study remains one non-randomized treatment strategy.
| Arm | Type | Receives |
|---|---|---|
| Biomarker-guided dual-target CAR-T therapy | Experimental | Biological: Autologous dual-target CAR-T cells selected from the predefined target library., Drug: Fludarabine, Drug: CyclophosphamideParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Biomarker-guided dual-target CAR-T therapy |
| FludarabineAlso: lymphodepletionchemotherapy 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 | Biomarker-guided dual-target CAR-T therapy |
| CyclophosphamideAlso: lymphodepletionCyclophosphamide 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. | Drug | Biomarker-guided dual-target CAR-T therapy |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: 28 Days
Incidence and severity of treatment-emergent adverse events
Time frame: 12 Months
3 secondary outcomes
Objective response rate (ORR) by RECIST 1.1 or RANO
Time frame: 24 Months
Disease control rate (DCR)
Time frame: 24 Months
Duration of response (DoR)
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Related trials for Advanced Unresectable
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
RecruitingPhase 2
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous dual-target CAR-T cells selected from the predefined target library., Fludarabine and Cyclophosphamide in people with Advanced Unresectable and Metastatic, run by Beijing Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shan S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLTs) (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.