CLDN18.2 Positive Solid TumorsEarly Phase 1NCT07680257
An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors
A Early Phase 1 study testing SUV2208A cell injection and SUV2208A in people with CLDN18.2 Positive Solid Tumors, run by Celest Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CLDN18.2 Positive Solid Tumors
- What is being tested?
- SUV2208A cell injection and SUV2208A
- 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
- 27 Dec 2025to 31 Dec 2028
- 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
- Willing to sign the Informed Consent Form (ICF) and comply with predefined visits and related procedures;
- Age 18 to 75, male or female;
- Cytology or histology confirmed advanced malignant solid tumors, with moderate to high expression of CLDN18.2;
- Locally advanced or metastatic solid tumors that are failed of, or refractory to, or contraindicated for standard of care;
- ECOG PS 0-1;
- The life expectency ≥ 3 months;
- Has sufficient organ and bone marrow function.
Who cannot join
- Have active central nervous system metastases or infiltration;
- Has previously received a bone marrow or organ transplant (including, but not limited to, a liver transplant) or is awaiting a transplant;
- History of or concurrent other malignancies (cured cervical carcinoma in situ with no recurrence within at least 2 years prior to screening, non-invasive basal cell or squamous cell carcinoma of the skin, locally advanced prostate cancer treated with radical surgery, or post-radical surgery ductal carcinoma in situ may be eligible for the study).
- Infectious disease;
- Adverse events caused by prior anti-tumor therapy that have not resolved to grade 1 or baseline, except for alopecia, grade 2 peripheral neuropathy, and stable hypothyroidism with hormone replacement therapy;
- Have received live attenuated vaccine within one month before screening, or plan to receive live attenuated vaccine during the study;
- Have major surgery (except liver space-occupying biopsy) within one month before screening, or have planned major surgery during the study.
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
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, 230022
Huan Zhou, +86 13665527160, zhouhuanbest@vip.163.com
Li Zhang, +86 18655125703, 715011385@qq.com
About this study
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
Read the detailed description
This study is an open, single/multiple infusion, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of CAR-CLDN18.2 T cell therapy, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with positive claudin 18.2 expression and failed to standard systemic treatment.
- Conditions
- CLDN18.2 Positive Solid Tumors
- Being tested
- SUV2208A cell injection, SUV2208A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUV2208A cell injectionBiological
SUV2208A, DL1, 2 times, Day 0 and Day 28, IV
SUV2208ABiological
SUV2208A, DL2, 2 times, Day 0 and Day 28, IV
SUV2208ABiological
SUV2208A, DL3, 2 times, Day 0 and Day 28, IV
| Study group | Role | What they receive |
|---|---|---|
| SUV2208A DL1 | Experimental | Dose level 1 Receives: Biological: SUV2208A cell injection |
| SUV2208A DL2 | Experimental | Dose level 2 Receives: Biological: SUV2208A |
| SUV2208A DL3 | Experimental | Dose level 3 Receives: Biological: SUV2208A |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
DLT incidence within 24 days after infusion of SUV2208A.
Measured: within 24 days from Day 0
AE/SAE
The incidence, severity, and corelaton of adverse events (AE) and serious adverse events (SAE).
Measured: within 2 years from Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start27 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLDN18.2 Positive 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The escalation scheme combines an accelerated titration phase (Dose level 1) followed by the conventional "3+3" design (Dose level 2, Dose level 3).
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celest Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680257
- Sponsor's protocol ID
- SUV2208A-01
- Status last verified
- Jan 2026
- First submitted
- 22 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07680257
- Acronym / sponsor ID
- SUV2208A-01
- Conditions
- CLDN18.2 Positive Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Celest Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Study start
- 27 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jul 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.
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
Detailed description
This study is an open, single/multiple infusion, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of CAR-CLDN18.2 T cell therapy, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with positive claudin 18.2 expression and failed to standard systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The escalation scheme combines an accelerated titration phase (Dose level 1) followed by the conventional "3+3" design (Dose level 2, Dose level 3).
| Arm | Type | Receives |
|---|---|---|
| SUV2208A DL1 | Experimental | Biological: SUV2208A cell injectionDose level 1 |
| SUV2208A DL2 | Experimental | Biological: SUV2208ADose level 2 |
| SUV2208A DL3 | Experimental | Biological: SUV2208ADose level 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to sign the Informed Consent Form (ICF) and comply with predefined visits and related procedures;
- Age 18 to 75, male or female;
- Cytology or histology confirmed advanced malignant solid tumors, with moderate to high expression of CLDN18.2;
- Locally advanced or metastatic solid tumors that are failed of, or refractory to, or contraindicated for standard of care;
- ECOG PS 0-1;
Key exclusion criteria (7 listed)
- Have active central nervous system metastases or infiltration;
- Has previously received a bone marrow or organ transplant (including, but not limited to, a liver transplant) or is awaiting a transplant;
- History of or concurrent other malignancies (cured cervical carcinoma in situ with no recurrence within at least 2 years prior to screening, non-invasive basal cell or squamous cell carcinoma of the skin, locally advanced prostate cancer treated with radical surgery, or post-radical surgery ductal carcinoma in situ may be eligible for the study).
- Infectious disease;
- Adverse events caused by prior anti-tumor therapy that have not resolved to grade 1 or baseline, except for alopecia, grade 2 peripheral neuropathy, and stable hypothyroidism with hormone replacement 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 |
|---|---|---|
| SUV2208A cell injectionSUV2208A, DL1, 2 times, Day 0 and Day 28, IV | Biological | SUV2208A DL1 |
| SUV2208ASUV2208A, DL2, 2 times, Day 0 and Day 28, IV | Biological | SUV2208A DL2 |
| SUV2208ASUV2208A, DL3, 2 times, Day 0 and Day 28, IV | Biological | SUV2208A DL3 |
Primary outcome
DLT
Time frame: within 24 days from Day 0
DLT incidence within 24 days after infusion of SUV2208A.
AE/SAE
Time frame: within 2 years from Day 0
The incidence, severity, and corelaton of adverse events (AE) and serious adverse events (SAE).
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 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for CLDN18.2 Positive Solid Tumors
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Advanced Solid Tumors (Such as Gastric Cancer), Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction)
RecruitingPhase 1
SG1906 for CLDN18.2-Positive Solid Tumors
Locally Advanced Unresectable or Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase I/II Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors
Claudin 18.2, Solid Tumor Malignancies
RecruitingPhase 2
IBI343 in Combination Therapy for Advanced Malignant Solid Tumors
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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 SUV2208A cell injection and SUV2208A in people with CLDN18.2 Positive Solid Tumors, run by Celest Therapeutics (Shanghai) 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 7 inclusion and 7 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 2 Jul 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 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 Huan Zhou (+86 13665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: within 24 days from Day 0). 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 2 Jul 2026.