Immunotherapy for gastrointestinal (GI) cancer
Antigen-specific Engineered Immune Effector Cells (EIE) Against Gastro-Intestinal (GI) Cancer
This trial will test whether infusing a patient's own engineered immune cells (including CAR-modified cells) can safely treat people with advanced GI cancers whose tumors express certain antigens.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 80 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | chemotherapy, chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT03614650 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional trial uses autologous ex vivo–manipulated engineered immune effector (EIE) cells, including chimeric antigen receptor (CAR)–modified cells, delivered by intravenous and/or intratumoral injection. Patients must have histologically confirmed GI malignancies with tumor staining positive for one or more specified tumor-associated antigens and meet specified performance and organ-function criteria. The primary focus in early phases is safety and tolerability of the infused cells, with secondary objectives addressing preliminary anti-tumor activity. Treatment is personalized based on antigen expression and uses cell manufacturing from each patient's own immune cells.
Who should consider this trial
Good fit: Adults with histologically confirmed advanced gastrointestinal cancers whose tumor tests positive for one or more listed tumor-associated antigens, with ECOG performance status 0–2, adequate organ function, life expectancy ≥3 months, and ability to provide informed consent are ideal candidates.
Not a fit: Patients whose tumors do not express the required antigens, who have poor performance status or inadequate organ function, pregnant patients, or those with very limited life expectancy are unlikely to benefit.
Why it matters
Potential benefit: If successful, patients could experience tumor shrinkage or longer survival from a targeted, personalized cellular immunotherapy.
How similar studies have performed: Adoptive T-cell and CAR therapies have shown major success in some blood cancers but remain early and less proven for solid tumors like GI cancers, so this approach builds on promising concepts but is not yet established for GI disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens positive for any one or more of tumor-associated antigens, such as GD2, mesothelin, CEA, P16, MMP, Melan A, MAGE A1, MAGE A3, and MAGE A4. 3\. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV. 7\. Not pregnant, and on appropriate birth control if of childbearing potential. 8. Adequate bone marrow reserve with • absolute neutrophil count (ANC) ≥ 1000/mm3.• Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with• Serum creatinine ≤ 2 x upper limit of normal (ULN).• Serum bilirubin ≤ 2 x ULN.• aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.• Alkaline phosphatase ≤ 5 x ULN.• Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome. Exclusion Criteria: * 1\. The results of immune staining of the patient's tumor-associated antigens are all negative. 2\. Participation in any other cell therapy protocols within one year. 3. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug. 4\. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). 5\. Pregnant or lactating females. 6. Unable to comply with the trial related requirement. 7. Inadequate bone marrow function: * Absolute neutrophil count \< 1.0 x 10e9/L. * Platelet count \< 100 x 10e9/L. * Hb \< 9 g/dL. Inadequate liver and renal function: * Serum (total) bilirubin \> 1.5 x ULN.• AST \& ALT \> 2.5 x ULN (\> 5 x ULN in patients with liver metastases). * Alkaline phosphatase \> 2.5 x ULN (or \> 5 x ULN in case of liver metastases or \> 10 x ULN in case of bone metastases). * Serum creatinine \>2.0 mg/dl (\> 177 μmol/L). * Urine dipstick for protein uria should be \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate \< 1 g of protein/24 hr. 8\. Serious active infection requiring i.v. antibiotics during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: 86-075586725195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.