Clinical trial · Interventional
Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies
Autologous Immunotherapy With Multi-target Gene-modified CAR-T/TCR-T Cell for Malignancies
NCT03638206CI-TRIAL-00042180unknownPhase 1 / Phase 2ClinicalTrials.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)
This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophagus Cancer | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Hepatoma | Hepatocellular Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Mesothelioma | Malignant Mesothelioma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cell immunotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T cell immunotherapy
- description
- Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.
- interventionNames
- Biological: CAR-T cell immunotherapy
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
- timeFrame
- 60 months
- description
- Safety evaluation
Secondary outcomes (2)
- measure
- Clinical response
- timeFrame
- 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. If patients had receive immunotherapy, they should reach PR/NR, or recurrency. 2. Patients must be willing to sign an informed consent. 3. age: 4 to 70 years 4. Estimated survival of ≥ 12 weeks, but ≤ 2 years 5. Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A\*0201 is required at the same time . 6. Subjects with solid tumor must have measureable disease 7. Routine blood test:hemoglobin\>=90 g/L; platelet\>=50×10\^9/L. 8. Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min 9. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded) 10. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%. 11. ECOG score ≤2 12. Adequate venous access for apheresis, and no other contraindications for leukapheresis 13. Women of child-bearing age must have evidence of negative pregnancy test. 14. Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol. Exclusion Criteria: 1. ECOG \>= 3 2. Patients with history of T cell tumors 3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions 4. Acute or chronic GVHD after allogeneic hematopoiesis 5. steroid hormoneswere used before and after blood collection and infusion 6. HIV infection or active hepatitis B or hepatitis C infection 7. Uncontrolled active infection 8. Enrolled to other clinical study in the last 4 weeks. 9. Subjects with systemic auto-immune disease or immunodeficiency. 10. Subjects with CNS diseases. 11. Other patients that researchers considered unsuitable for inclusion
References
Publications (0)
Data not yet available
No reference posted for this study.