Clinical trial · Interventional
Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC
A Clinical Study of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Patients With Advanced Non-small Cell Lung Cancer
NCT03525782CI-TRIAL-00032965unknownPhase 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)
The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasm Malignant | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T Cells | Biological | — | UNRESOLVED |
| CAR-T combining PD-1 Knockout | Combination Product | — | UNRESOLVED |
| PD-1 knockout | Biological | — | UNRESOLVED |
| PD-1 mAb | Drug | — | UNRESOLVED |
| Sham control | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- CAR-T
- description
- Anti-MUC1 CAR-T cells will be prepared ex vivo and infused back to the patients.
- interventionNames
- Biological: CAR-T Cells
- type
- EXPERIMENTAL
- label
- CAR-T combining PD-1 knockout
- description
- Anti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo and infused back to the patients.
- interventionNames
- Biological: CAR-T Cells
- Combination Product: CAR-T combining PD-1 Knockout
- Biological: PD-1 knockout
- type
- EXPERIMENTAL
- label
- PD-1 knockout
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC). * Eastern cooperative oncology group (ECOG) performance status of 0-1 or karnofsky performance status (KPS) score is higher than 60. * Patients have a life expectancy \> 12 weeks. * Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis. * Negative pregnancy test for females of child-bearing potentials. * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration. * Signed informed consent form. Exclusion Criteria: * Number of T cells is less than 10% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times. * Patients with symptomatic central nervous system (CNS) involvement. * Pregnant or nursing women. * Known HIV infection. * Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders. * History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin. * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previously treatment with any gene therapy products. * The existence of unstable or active ulcers or gastrointestinal bleeding. Patients with portal vein vascular invasion or extrahepatic, are excluded from this study. * Patients with a history of organ transplantation or are waiting for organ transplantation.
References
Publications (1)
- DERIVEDBarr T, Ma S, Li Z, Yu J. Recent advances and remaining challenges in lung cancer therapy. Chin Med J (Engl). 2024 Mar 5;137(5):533-546. doi: 10.1097/CM9.0000000000002991. Epub 2024 Feb 7. PMID 38321811