Clinical trial · Interventional
CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor
A Clinical Study of CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for Patients With EGFR Positive Advanced Solid Tumors
- 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, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies (CTLA-4 and PD-1) and chimeric antigen receptor targeting epidermal growth factor receptor (EGFR-CAR) in adult patients with EGFR positive, advanced recurrent or refractory malignant solid tumors.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CTLA-4/PD-1 expressing EGFR-CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CTLA-4/PD-1 expressing EGFR-CAR-T
- description
- This study have only one arm that is anti-CTLA-4/PD-1 expressing EGFR-CAR-T group. All patients with advanced solid tumor will take part in the screening, who matching all the conditions will be chosen for the treatment using CTLA-4 and PD-1 antibodies expressing EGFR-targeted CAR-T cells. New CAR-T cells are cultured from PBMC and returned to the patients by venous transfusion.
- interventionNames
- Biological: anti-CTLA-4/PD-1 expressing EGFR-CAR-T
Primary outcomes (1)
- measure
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 2 years
- description
- Determine treatment-related adverse events of the immunotherapy with common toxicity criteria for adverse effects (CTCAE) version 4.0.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with relapsed or refractory advanced solid malignancies (diagnosed by histology or cytology detection). 2. Progressive disease and no response after at least second-line therapy. 3. Gender unlimited, age from 18 years to 80 years. 4. Life expectancy ≥3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Adequate venous access for peripheral blood mononuclear cell (PBMC) apheresis, and no other contraindications. 7. Immunohistochemistry (IHC) score of EGFR on tumor tissue ≥1+. 8. Adequate hepatic function, renal function and bone marrow function (withhin 7 days before enrollment): white blood cell (WBC) ≥3.0×10\^9/L; platelet ≥100×10\^9/L; hemoglobin ≥90 g/L; lymphocyte ≥0.7×10\^9/L; total bilirubin ≤2 times the upper limit of the normal value; alanine aminotransferase and aspartate transaminase(ALT and AST) ≤2.5 times the upper limit of the normal value; serum creatinine ≤1.5 times the upper limit of the normal value. 9. There is no other treatments (chemotherapy, radiotherapy, etc.) within four weeks before enrollment. 10. There is at least one measurable tumor lesion. 11. Patients have adequate ability to understand, sign informed consents and take part in the clinical research voluntarily. 12. Female patients in child bearing period must have evidence of negative pregnancy test, and agree to take effective contraceptive measures until 4 months after cells infusion. Exclusion Criteria: 1. Patients with two or more kinds of tumors. 2. Patients with active viral or bacterial infection, and have failed to be controlled by anti-infective treatment. 3. Patients with seropositive reponse of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection. 4. Patients with active rheumatic diseases, organ transplantation and other diseases affecting the immune system seriously. 5. Patients with severe heart and lung dysfunction. 6. Patients with severe chronic diseases of kidney, liver and other important organs. 7. Patients with any other serious illnesse that the investigators consider it will may affect the patient's treatments, follow-up or assessment, including any uncontrolled clinically significant neurological or psychiatric disorders, immunoregulatory diseases, metabolic diseases, infectious diseases and so on. 8. Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment. 9. Patients who need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases. 10. Patients who need long-term use of glucocorticoid. 11. Women patients in gestation period or suckling period.
References
Publications (1)
- DERIVEDZhang Y, Zhang Z, Ding Y, Fang Y, Wang P, Chu W, Jin Z, Yang X, Wang J, Lou J, Qian Q. Phase I clinical trial of EGFR-specific CAR-T cells generated by the piggyBac transposon system in advanced relapsed/refractory non-small cell lung cancer patients. J Cancer Res Clin Oncol. 2021 Dec;147(12):3725-3734. doi: 10.1007/s00432-021-03613-7. Epub 2021 May 25. PMID 34032893