Clinical trial · Interventional
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
NCT07680257CI-TRIAL-00116649recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLDN18.2 Positive Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SUV2208A | Biological | — | UNRESOLVED |
| SUV2208A cell injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SUV2208A DL1
- description
- Dose level 1
- interventionNames
- Biological: SUV2208A cell injection
- type
- EXPERIMENTAL
- label
- SUV2208A DL2
- description
- Dose level 2
- interventionNames
- Biological: SUV2208A
- type
- EXPERIMENTAL
- label
- SUV2208A DL3
- description
- Dose level 3
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.