Clinical trial · Interventional
EGFR CART Cells for Patients With Metastatic Colorectal Cancer
Phase I/II Study of EGFR CART Cells for Patients With Metastatic Colorectal Cancer.
NCT03152435CI-TRIAL-00029093unknownPhase 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 clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR 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 |
|---|---|---|---|
| EGFR-positive Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR CART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-tumor response of CART-EGFR
- interventionNames
- Biological: EGFR CART
Primary outcomes (1)
- measure
- Occurrence of study related adverse events as assessed by CTCAE v4.0
- timeFrame
- 24 weeks
Secondary outcomes (2)
- measure
- Anti-tumor responses to EGFR CART cells in vivo.
- timeFrame
- 24 weeks
- measure
- Determine duration of in vivo survival of EGFR CART .
- timeFrame
- 1 year
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 ≥ 4.0×109/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.