Clinical trial · Interventional
EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
Phase I/II Study of EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
NCT03542799CI-TRIAL-00033141EGFRCARTunknownPhase 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)
This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients with colorectal 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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR IL12 CART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3
- description
- anti-tumor response of EGFR IL12 CART
- interventionNames
- Biological: EGFR IL12 CART
Primary outcomes (1)
- measure
- Safety: Occurrence of study related adverse events
- timeFrame
- 24 weeks
- description
- Occurrence of study related adverse events as assessed by CTCAE v4.0
Secondary outcomes (2)
- measure
- Effectiveness: Changes of tumor markers
- timeFrame
- 24 weeks
- description
- Changes of tumor markers CA-199, AFP and CEA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be 18 years to 70 years; 2. Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer; 3. Patients must have a KPS of \>80, expected survival \> 3 months; 4. Patients must have at least one measurable lesions; 5. Recently did not use glucocorticoid; 6. Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L); AST ≤2.5ULN,ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN, 7. Patients must have a good heart function (LVEF\>50%) ; 8. Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment; 9. Patients must be willing to sign an informed consent. Exclusion Criteria: 1. Patients with other cancer history; 2. Patients allergic to cetuximab; 3. Patients with severe bronchitis, bronchial asthma, or severs pneumonia; 4. Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ; 5. Patients with acute and chronic GVHD (graft versus host disease) 6. Patients with severe autoimmune diseases; 7. Previously treatment with T cell inhibitors (cyclophosphamide, FK506); 8. Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive; 9. Patients who are participating or participated any other clinical research in the past 1 months; 10. Pregnant and/or lactating women will be excluded; -
References
Publications (0)
Data not yet available
No reference posted for this study.