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

NCT07680257 | Recruiting Early Phase 1

• 1 other identifier: SUV2208A-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CLDN18.2 Positive Solid Tumors

Outcome Measures

Primary Outcomes (2)

• DLT

  DLT incidence within 24 days after infusion of SUV2208A.

  within 24 days from Day 0

• AE/SAE

  The incidence, severity, and corelaton of adverse events (AE) and serious adverse events (SAE).

  within 2 years from Day 0

Study Arms (3)

SUV2208A DL1

EXPERIMENTAL

Dose level 1

Biological: SUV2208A cell injection

SUV2208A DL2

EXPERIMENTAL

Dose level 2

Biological: SUV2208A

SUV2208A DL3

EXPERIMENTAL

Dose level 3

Biological: SUV2208A

Interventions

SUV2208A cell injection BIOLOGICAL

SUV2208A, DL1, 2 times, Day 0 and Day 28, IV

SUV2208A DL1

SUV2208A BIOLOGICAL

SUV2208A, DL2, 2 times, Day 0 and Day 28, IV

SUV2208A DL2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celest Therapeutics (Shanghai) Co., Ltd.: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

Central Study Contacts

Huan Zhou

CONTACT

+86 13665527160; zhouhuanbest@vip.163.com

Li Zhang

CONTACT

+86 18655125703; 715011385@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The escalation scheme combines an accelerated titration phase (Dose level 1) followed by the conventional "3+3" design (Dose level 2, Dose level 3).

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 2, 2026
• Study Start: December 27, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)