Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

NCT03535246 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-18001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cancer

Keywords

immunotherapy; T cell; Cancer; Gene therapy

Outcome Measures

Primary Outcomes (1)

• percentage of adverse effects after EIE cell injection

  To assess the safety of autologous EIE cells in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.

  up to one month

Secondary Outcomes (3)

• Rate of successful EIE generation

  up to one month

• Ability of EIE cells to induce anti-cancer reaction

  after 1 month from EIE cells infusion until 12 months after infusion

• Ability of EIE cells for anti-cancer reaction

  after 1 month from EIE cells infusion until 24 months after infusion

Study Arms (1)

Single arm

EXPERIMENTAL

EIE cells to treat cancer.

Biological: Engineered Immune Cells

Interventions

Engineered Immune Cells BIOLOGICAL

Engineered immune effector cells (EIE)

Single arm

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:

• \. 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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (3)

QiFu Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510415, China

RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-075586725195; c@szgimi.org

Yichun Cai, MD

CONTACT

86-13802830754

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 24, 2018
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)