Clinical trial · Interventional
Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer
Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) in the Treatment of Chinese Patients With Advanced Gastric Cancer
NCT06432075CI-TRIAL-00077517not yet recruitingEarly 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)
The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) in the treatment of Chinese patients with advanced gastric cancer.
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 Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoantigen Reactive T Cells(NRTs) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoantigen Reactive T Cells
- description
- Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory;nab-paclitaxel 100-200mg/m2/D will be i.v. for 7 days before cell infusion; Cyclophosphamide 300mg/m2/D will be i.v. for 2 and 3 days before cell infusion; NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4 doses;Interleukin-2 (IL-2) will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 1000,000 international unit per day.All Patients will receive a total of 4 cycles of treatment.
- interventionNames
- Biological: Neoantigen Reactive T Cells(NRTs)
Primary outcomes (1)
- measure
- Number of participants with Adverse Events
- timeFrame
- up to 6 months
- description
- using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily join the study and sign the informed consent; 2. Age: 18-75 years old, male or female; 3. Subjects with advanced gastric cancer who had received systematic standard treatment before enrollment and had no effective treatment at present. (Note: The effective treatment means refer to the latest version of the "Gastric Cancer Diagnosis and Treatment Guide" issued by China's "Chinese Clinical Oncology Society".) ; 4. Have at least one measurable lesion according to imRECIST evaluation criteria; 5. Expected survival ≥5 months (starting from the collection of tissue samples for sequencing); 6. The Eastern Cancer Consortium (ECOG) score was 0 or 1 or 2; 7. The following hematological indicators should be met: neutrophil count ≥ 1.5×109/L; Hemoglobin ≥ 10.0 g/dL; Platelet count ≥ 50×109/L; 8. The following biochemical indicators should be met: total bilirubin ≤2.0× upper limit of normal value (ULN); AST and ALT ≤2.0×ULN; Serum creatinine ≤1.5×ULN. 9. Before lymphocyte clearance preadministration: 1) any chemotherapy, small molecule targeted drugs and other antitumor therapy received have passed the 3-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo and other events as determined by the investigator to be tolerated); 2) If surgical treatment is performed within 3 weeks, toxicity has returned to grade 1 or lower; 3) The immunotoxicity of major organs has returned to grade 1 or lower after receiving any antibody drug treatment, and the washout period of PD-1 antibodies has reached 6 weeks, and CTLA-4 antibodies and other antibodies have passed the washout period of 4 weeks. Exclusion Criteria: 1. Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis; 2. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or what the investigator considers Other diseases not included in the group; 3. Patients with a history of bone marrow or organ transplantation; Patients with coagulation dysfunction; 4. Patients with immune deficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs; 5. Central nervous system (CNS) metastatic and/or cancerous meningitis; 6. People who may be allergic to immunotherapy; 7. Drug abuse, clinical or psychological or social factors that affect informed consent or the conduct of the study; 8. Pregnant and lactating women; 9. Participating in other clinical trials; 10. An uncertainty that the investigator believes has an impact on the subject's safety or compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.