Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

Recruiting now · Phase 1/Phase 2

Conditions studied: Cancer

In brief

The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).

Key facts

Study ID

NCT03535246

Run by

Shenzhen Geno-Immune Medical Institute

People needed

100

Starts

2025-07-01

Expected to finish

2029-12-31

Last updated by the study team

2026-06-22

Who can join

Age: 1 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Not pregnant, and on appropriate birth control if of childbearing potential.
• 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.

You may not qualify if…

• 1. The results of immune staining of the patient's tumor-associated antigens are all negative.
• 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.
• Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
• 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.
• 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.

Where it is running

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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