Claudin18.2 Positive Advanced Solid TumorsEarly Phase 1NCT07266311
CAR-T for Claudin18.2 Positive Solid Tumors
A Early Phase 1 study testing claudin18.2 CAR-T in people with Claudin18.2 Positive Advanced Solid Tumors, run by Chengdu Ucello Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Claudin18.2 Positive Advanced Solid Tumors
- What is being tested?
- claudin18.2 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 31 Dec 2037
- Phase
- Early Phase 1
- 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
- Aged 18 to 75 years at the time of signing the the informed consent form (ICF).
- Pathologically confirmed advanced solid tumor and patients have failed at least 2 prior lines of systemic therapy; or patients with advanced pancreatic cancer who have failed at least 1 prior line of systemic therapy.
- Tumor tissue testing meets the requirement: Positive for Claudin 18.2 (CLDN18.2) by immunohistochemistry (IHC) staining.
- Estimated life expectancy ≥ 12 weeks from the time of screening.
- Presence of measurable tumor lesions in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 at screening, within 24 hours prior to apheresis, and at baseline.
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- Has adequate venous access to allow successful collection of peripheral blood mononuclear cells (PBMCs).
- Meets the specified laboratory test criteria at screening and pre-treatment (see Appendix for detailed parameters). For abnormal laboratory results that do not meet the criteria, a retest is permitted within 1 week; if the retest still fails to meet the criteria, the patient is deemed ineligible for screening.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening and pre-treatment. They must agree to use a highly effective and reliable contraceptive method for 1 year after the last study treatment.
- Male patients who are sexually active with women of childbearing potential must agree to use barrier contraception (unless they have undergone vasectomy) during the study and for 1 year after the last study treatment.
- Voluntarily agrees to participate in the clinical trial, has been fully informed of the study details, signs the ICF, and is willing to comply with and capable of completing all study procedures.
Who cannot join
- Pregnant or lactating women.
- Serologically positive for human immunodeficiency virus (HIV), Treponema pallidum, or hepatitis C virus (HCV); or positive for Epstein-Barr virus (EBV)-DNA, cytomegalovirus (CMV)-DNA, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid.
- Presence of any uncontrolled active infection, including but not limited to active tuberculosis and active hepatitis B virus (HBV) infection (defined as HBsAg positive with detectable HBV-DNA).
- Persistent toxicities from prior anti-tumor therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1, except for tolerable events such as alopecia as determined by the investigator.
- Known history of active autoimmune diseases (including but not limited to psoriasis, rheumatoid arthritis) or other conditions requiring long-term immunosuppressive therapy.
- History of hypersensitivity to immunotherapeutic agents or related drugs, history of severe allergies, or hypersensitivity to any component of CAR-T injection.
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- Presence of brain metastases or symptoms related to brain metastases.
- Patients at high risk of bleeding or perforation (e.g., active gastrointestinal ulcer, recent gastrointestinal bleeding within 3 months).
- Patients requiring anticoagulant therapy.
- Patients requiring continuous antiplatelet therapy.
- History of organ transplantation or awaiting organ transplantation.
- History of major surgery or significant trauma within 4 weeks prior to apheresis, or planned major surgery during the study period.
- Presence of other serious pre-existing medical conditions that may limit the patient's participation in the study (e.g., severe cardiac, hepatic, or renal dysfunction).
- Assessed by the investigator as unable or unwilling to comply with the study protocol requirements.
- Presence of clinically significant central nervous system (CNS) disease signs or abnormally significant neurological test results.
- Current diagnosis or history of other incurable malignant tumors within the past 3 years, except for in situ cervical cancer or basal cell carcinoma of the skin (which are considered cured after appropriate treatment).
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
The General Hospital of Western Theater Command
Chengdu, Sichuan
17311079545
About this study
Official title: Clinical Study on the Safety and Efficacy of CAR T-cell Therapy for Claudin18.2 Positive Advanced Solid Malignant Tumors
The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product.
The main questions it aims to answer are:
Read more
- What CAR-T-related adverse events (AEs) occur within 3 months after the autologous CAR-T cell infusion?
- What is the Objective Response Rate (ORR), Progression-free survival (PFS), duration of response (DOR), and overall survival (OS)?
Participants will:
- Undergo leukapheresis for collection of autologous T cells for CAR-T cell manufacturing.
- May receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) for 3 consecutive days if clinically needed.
- If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1.
- Receive autologous CAR-T cells infusion on Day 0.
- Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.
- Visit the clinic at Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
- Being tested
- claudin18.2 CAR-T
- Keywords
- claudin18.2, CAR-T, CAR T-cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
claudin18.2 CAR-TDrug
injection of CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells treatment | Experimental | Not described Receives: Drug: claudin18.2 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of CAR-T-related adverse events
Measured: up to 3 months after CAR-T injection
Secondary outcomes (4)
objective response rate (ORR)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Measured: up to 18 months
Progression-free survival (PFS)
Measured: up to 18 months
Duration of response (DOR)
Measured: up to 18 months
Overall Survival (OS)
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Claudin18.2 Positive Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Ucello Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The General Hospital of Western Theater Command
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266311
- Sponsor's protocol ID
- CAR-T_CLDN18.2
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of CAR T-cell Therapy for Claudin18.2 Positive Advanced Solid Malignant Tumors
- ClinicalTrials.gov ID
- NCT07266311
- Acronym / sponsor ID
- CAR-T_CLDN18.2
- Keywords
- claudin18.2, CAR-T, CAR T-cell therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chengdu Ucello Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The General Hospital of Western Theater Command
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 5 Dec 2025 (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.
The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product.
The main questions it aims to answer are:
- What CAR-T-related adverse events (AEs) occur within 3 months after the autologous CAR-T cell infusion?
- What is the Objective Response Rate (ORR), Progression-free survival (PFS), duration of response (DOR), and overall survival (OS)?
Participants will:
- Undergo leukapheresis for collection of autologous T cells for CAR-T cell manufacturing.
- May receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) for 3 consecutive days if clinically needed.
- If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1.
- Receive autologous CAR-T cells infusion on Day 0.
- Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.
- Visit the clinic at Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T cells treatment | Experimental | Drug: claudin18.2 CAR-T |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 to 75 years at the time of signing the the informed consent form (ICF).
- Pathologically confirmed advanced solid tumor and patients have failed at least 2 prior lines of systemic therapy; or patients with advanced pancreatic cancer who have failed at least 1 prior line of systemic therapy.
- Tumor tissue testing meets the requirement: Positive for Claudin 18.2 (CLDN18.2) by immunohistochemistry (IHC) staining.
- Estimated life expectancy ≥ 12 weeks from the time of screening.
- Presence of measurable tumor lesions in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Key exclusion criteria (16 listed)
- Pregnant or lactating women.
- Serologically positive for human immunodeficiency virus (HIV), Treponema pallidum, or hepatitis C virus (HCV); or positive for Epstein-Barr virus (EBV)-DNA, cytomegalovirus (CMV)-DNA, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid.
- Presence of any uncontrolled active infection, including but not limited to active tuberculosis and active hepatitis B virus (HBV) infection (defined as HBsAg positive with detectable HBV-DNA).
- Persistent toxicities from prior anti-tumor therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1, except for tolerable events such as alopecia as determined by the investigator.
- Known history of active autoimmune diseases (including but not limited to psoriasis, rheumatoid arthritis) or other conditions requiring long-term immunosuppressive therapy.
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 |
|---|---|---|
| claudin18.2 CAR-Tinjection of CAR T cells | Drug | CAR-T cells treatment |
Primary outcome
the incidence rate of CAR-T-related adverse events
Time frame: up to 3 months after CAR-T injection
4 secondary outcomes
objective response rate (ORR)
Time frame: up to 18 months
Progression-free survival (PFS)
Time frame: up to 18 months
Duration of response (DOR)
Time frame: up to 18 months
Overall Survival (OS)
Time frame: up to 18 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 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing claudin18.2 CAR-T in people with Claudin18.2 Positive Advanced Solid Tumors, run by Chengdu Ucello Biotechnology Co., Ltd. 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 16 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: opening soon, as of the sponsor's last update on 5 Dec 2025. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Hai Yi, M.D. & Ph.D. (+8613699418229, yihaimail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rate of CAR-T-related adverse events (time frame: up to 3 months after CAR-T injection). 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 5 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.