Clinical trial · Interventional
Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.
An Open Label, Single/Multiple Dose Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Cytokinetics of Autologous Humanized Anti-claudin18.2 Chimeric Antigen Receptor T Cell in Advanced Solid Tumor Subjects
NCT03874897CI-TRIAL-00076589completedPhase 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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-CLDN18.2 T-Cells | Drug | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| PD-1 Monoclonal Antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- CAR-CLDN18.2 T-Cells
- description
- The subjects enrolled will be sequentially assigned to the corresponding dose level.
- interventionNames
- Drug: CAR-CLDN18.2 T-Cells
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- CT041 monotherapy in patients with GI cancers who failed standard chemotherapy
- interventionNames
- Drug: CAR-CLDN18.2 T-Cells
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- CT041 plus anti-PD1 therapy in patients with GI cancers who failed standard chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 to 75 years, male or female; 2. Subjects with pathologically confirmed solid tumors (ie, advanced gastric cancer, esophagogastricgastroesophageal junction cancer, and pancreatic cancer) and have been failed to at least first-one prior line of systemic treatment; 3. Tumor tissue samplessample was positive for claudin 18.2 positive through for claudin18.2 IHC staining;assay(≥2+, and ≥40%); 4. Estimated life expectancy \> 12 weeks; 5. According to the RECIST 1.1, there is at least one measurable or unmeasurable tumor lesionslesion; 6. ECOG physical status score 0 \~ 1, within 24 hours prior to apheresis, and at baseline (prior to pre-treatment); 7. Sufficient venous access for mononuclear cell collection (abbreviation: apheresis) 8. Subjects should have adequate organ functions before screening and pre-treatment (at baseline). 9. Female subjects of childbearing age must undergo a serum pregnancy test at screening and prior to preconditioning and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. The methods that can be used are: bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusion; or approved oral, injection or hormone-imparting contraceptive methods; or barrier contraceptive method: containing spermicidal foam / Gel/film/cream/suppository condom or occlusive cap (diaphragm or cervix/cap); 10. Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy, for example, a condom containing a spermicidal foam/gel/film/paste/suppository, or use a contraceptive method for their spouse (see article 9 of the inclusion criteria). Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last study treatment infusion; 11. Subject participates in this clinical trial and sign Informed Consent Form voluntarily. Exclusion Criteria: 1. Pregnant or lactating women; 2. HIV, Treponema pallidum or HCV serologically positive; 3. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection (HBsAg positive, or HBcAb positive and HBV DNA positive); 4. Subjects have clinically significant thyroid dysfunction determined by investigator (serum thyroid hormone assays TT4, TT3, FT3, FT4, and serum thyroid stimulating hormone TSH) which is not suitable for entering into the study; 5. The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; except hair loss and, hyperpigmentation or other tolerable events determined by investigator or laboratory abnormalities allowed by the protocol; 6. Subjects who are using steroidshave recieved ≥15 mg/day glucocorticoid systemically currently within 7 days prior to apheresis; those using inhaled steroids recently or currently are not excluded; 7. Previously allergic to immunotherapy and related drugs, history of severe allergiespreconditioning drug such as cyclophosphamide, fludarabine, or allergiestocilizumab or allergic to components of CT041CAR-CLDN18.2T injection, allergic to β-lactam antibiotics;the CT041 infusion; 8. Previously received any chimeric antigen receptor-modified T-cells(including CAR-T、TCR-T) . 9. Subjects have untreated or symptomatic brain metastases; 10. Subjects have central or extensivelywith centralcor diffused metastases in lung and .extensiveor diffused metastases in liver;liveror with rapid tumor progression since screening period evaluated by the investigator preconditioning (at baseline); 11. The largest target tumor lesion\>4cm 12. Subjects with unstable or active ulcers and gastrointestinal bleeding currently; 13. Subjects with a history of organ transplantation or awaiting organ transplantation; 14. Subjects requiring anticoagulant therapy; 15. Subjects requiring continuous anti-platelet therapy; 16. Subjects who have undergone major surgery or significant trauma within 4 weeks prior to apheresis, or who are expected to undergo major surgery during the study; 17. There are no other serious diseases that may limit subjects' participation in this trial; 18. The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol; 19. Blood oxygen saturation ≤ 95% before pre-treatmentapheresis or preconditioning (accept finger oxygen detection method); 20. Prior to pretreatmentpreconditioning, subjects developed, including but not limited to, new arrhythmias that could not be controlled with drugs, hypotension requiring pressor agent, bacterial, fungal or viral infections that required intravenous antibiotics. Creatinine clearance rate \<40mL / min; The investigator judges that the subject is not suitable for continuing the trial. Subjects who use antibiotics to prevent infection can continue the trials if judged by the investigator; 21. The subject has a central nervous system disease sign or an abnormal neurological test result with clinical significance; 22. The subject is currently suffered from or have suffered from other incurable malignant tumors within previous 3 years, except in situ cervical cancer or skin basal cell cancer.
References
Publications (6)
- DERIVEDLi J, Liu L, Tao M, Han Z, Ma M, Jiang L, Liu C, Liu D, Zhang P, Zhang M, Xue R, Gong J, Zhang X, Shen L, Qi C. Impact of concomitant medications on efficacy of CLDN18.2-specific CAR-T cell therapy in advanced gastric cancer. Br J Cancer. 2026 Feb;134(3):439-446. doi: 10.1038/s41416-025-03289-7. Epub 2025 Nov 29. PMID 41318814
- DERIVEDLi J, Tao M, Liu L, Liu C, Ma M, Liu D, Zhang P, Zhang M, Xue R, Gong J, Zhang C, Zhang X, Shen L, Qi C. Peripheral blood neutrophils contribute to Claudin18.2-specific CAR-T cell treatment resistance in advanced gastric cancer. Br J Cancer. 2025 Jun;132(12):1167-1176. doi: 10.1038/s41416-025-03015-3. Epub 2025 Apr 17. PMID 40246985
- DERIVEDQi C, Liu C, Gong J, Liu D, Wang X, Zhang P, Qin Y, Ge S, Zhang M, Peng Z, Zhou J, Lu Z, Lu M, Cao Y, Yuan J, Wang Y, Wang Z, Xue R, Peng X, Wang Y, Yuan D, Li J, Zhang X, Shen L. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results. Nat Med. 2024 Aug;30(8):2224-2234. doi: 10.1038/s41591-024-03037-z. Epub 2024 Jun 3. PMID 38830992
- DERIVEDQi C, Zhang P, Liu C, Zhang J, Zhou J, Yuan J, Liu D, Zhang M, Gong J, Wang X, Li J, Zhang X, Li N, Peng X, Liu Z, Yuan D, Baffa R, Wang Y, Shen L. Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials. J Clin Oncol. 2024 Jul 20;42(21):2565-2577. doi: 10.1200/JCO.23.02314. Epub 2024 May 24. PMID 38788174
- DERIVEDQi C, Xie T, Zhou J, Wang X, Gong J, Zhang X, Li J, Yuan J, Liu C, Shen L. CT041 CAR T cell therapy for Claudin18.2-positive metastatic pancreatic cancer. J Hematol Oncol. 2023 Sep 9;16(1):102. doi: 10.1186/s13045-023-01491-9. PMID 37689733
- DERIVEDQi C, Gong J, Li J, Liu D, Qin Y, Ge S, Zhang M, Peng Z, Zhou J, Cao Y, Zhang X, Lu Z, Lu M, Yuan J, Wang Z, Wang Y, Peng X, Gao H, Liu Z, Wang H, Yuan D, Xiao J, Ma H, Wang W, Li Z, Shen L. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial interim results. Nat Med. 2022 Jun;28(6):1189-1198. doi: 10.1038/s41591-022-01800-8. Epub 2022 May 9.