Supercharged immune cells take on cancer in new trial
NCT ID NCT03535246
First seen Jun 26, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This study tests whether specially engineered immune cells (EIE) can safely fight cancer. Researchers take a patient's own immune cells, modify them to target tumor-related markers, and infuse them back. The trial involves 100 people with various cancers whose tumors show specific antigens. The main goal is to check for side effects and see if the cells shrink tumors.
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 (EIE)
- What this could lead to
- If successful, this could provide a new treatment option for certain cancers by training the immune system to attack tumor cells.
- What could go wrong
- This is an early-phase trial with only 100 participants, so results may not apply to all cancers. 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
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100 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Jul 2026
- 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
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1 year to 80 years
- Sex
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Anyone
- Healthy volunteers
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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, 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\. Previous experience of other cell therapy. 3. Participation in any other cell therapy protocols within one year. 4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug. 5\. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). 6\. Pregnant or lactating females. 7. Unable to comply with the trial related requirement. 8. 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. 9\. Serious active infection requiring i.v. antibiotics at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.
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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.
Contacts and locations
Locations
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Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
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