Personalized cell therapy takes on GI cancers
NCT ID NCT03614650
First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This study tests a new treatment for gastrointestinal cancer using a patient's own immune cells, which are engineered in a lab to target cancer. About 100 participants will receive these cells to see if they are safe and can shrink tumors. The trial is currently recruiting and combines early safety testing with initial effectiveness checks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered immune cells
- What this could lead to
- If successful, this could point toward a new treatment option for gastrointestinal cancers using the patient's own immune cells.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with only 100 participants, so results may not apply broadly. Side effects from the cell therapy are possible and are being closely monitored.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2027
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 year to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can colorectal surgery patients go home in two days?
- Can a personal navigator help young cancer patients through treatment?
- Can a smartwatch predict which cancer patients return to hospital?
- Two-Drug combo aims to stall advanced breast cancer
- Blood thinner flush could boost tumor biopsy success
- Could a frailty score predict which older cancer patients survive intensive care?