Clinical trial · Interventional
Study Evaluating the Efficacy and Safety With CAR-T for Stomach Cancer
Single-arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Stomach Cancer
- 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)
This single-arm, multicenter Phase 2 trial will treat the patients who have relapsed or refractory stomach cancer with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR) that will bind to tumor cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumor cells.The trial will also study the safety of treatment with CAR-T, how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.
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 |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EPCAM-targeted CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-arm
- description
- Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:0days,the first day,the second day,28 days,29 days Duration:total five times
- interventionNames
- Biological: EPCAM-targeted CAR-T cells
Primary outcomes (1)
- measure
- Disease control rates
- timeFrame
- 0 to 180 days
Secondary outcomes (1)
- measure
- Duration of remission
- timeFrame
- 0 to 180 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. According to UICC or gastric cancer diagnosis and treatment guideline of diagnosis for patients with gastric cancer, first-line and second-line chemotherapy of advanced gastric cancer, and through flow cytometry or immune tissues (cell) chemistry, confirm the tumor cells positive expression of relevant molecular targets; 2. Age \<=75 years old, both male and female; 3. Is expected to survive more than 3 months; 4. Physical condition is good: 0-2 score ECOG score; 5. The lymphocyte count must \> =0.4\*10\^9/L at the time of collection of peripheral blood; 6. Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection; 7. Non pregnancy and lactation; 8. History of severe allergic reactions without biological products; 9. Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form; 10. At least one measurable lesion. Exclusion Criteria: 1. Pregnant or lactating women; 2. Organ failure, such as heart: Class III and IV; liver: to Chlid grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; 3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; 4. Long term use of immunosuppressive drugs or people with severe autoimmune diseases; 5. Any other chronic disease patients who have been treated with immune agents or hormone therapy; 6. A serious infectious disease with severe, uncontrollable, wound healing 7. Allergy to the interleukin and interferon cytokine; 8. Coagulation abnormalities and severe thrombosis; 9. Patients who have participated in other clinical trials or other clinical trials in the past 30 days 10. The Investigator believe the patients should not participate in this experiment.
References
Publications (0)
Data not yet available