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

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.

Study Overview

• Status: Recruiting
• Conditions: CLDN18.2 Positive Solid Tumors
• Intervention / Treatment: Biological: SUV2208A cell injection; Biological: SUV2208A; Biological: SUV2208A

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 Type: Interventional
• Enrollment (Estimated): 18
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Huan Zhou; Phone Number: +86 13665527160; Email: zhouhuanbest@vip.163.com
• Study Contact Backup: Name: Li Zhang; Phone Number: +86 18655125703; Email: 715011385@qq.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Huan Zhou; Phone Number: +86 13665527160; Email: zhouhuanbest@vip.163.com
      • Contact: Li Zhang; Phone Number: +86 18655125703; Email: 715011385@qq.com
      • Principal Investigator: Huan Zhou, Professor
      • Principal Investigator: Guoping Sun, Cheif Physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUV2208A DL1; Dose level 1	Biological: SUV2208A cell injection; SUV2208A, DL1, 2 times, Day 0 and Day 28, IV
Experimental: SUV2208A DL2; Dose level 2	Biological: SUV2208A; SUV2208A, DL2, 2 times, Day 0 and Day 28, IV; Biological: SUV2208A; SUV2208A, DL3, 2 times, Day 0 and Day 28, IV
Experimental: SUV2208A DL3; Dose level 3	Biological: SUV2208A; SUV2208A, DL2, 2 times, Day 0 and Day 28, IV; Biological: SUV2208A; SUV2208A, DL3, 2 times, Day 0 and Day 28, IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SUV2208A-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No