RecruitingPhase 1Phase 2NCT03535246

Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

Tumor Associated Antigen-specific Engineered Immune Effector Cells (EIE) Against Cancer

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

100 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer

Summary

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

Eligibility

Min Age: 1 YearMax Age: 80 Years

Inclusion Criteria11

\. 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.

Exclusion Criteria12

\. 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.