Genetically Modified T Cells Against Ovarian Cancer

NCT03184753 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-17002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).

Conditions

Ovarian Cancer

Keywords

Autologous; IgT; Ovarian Cancer; CART

Outcome Measures

Primary Outcomes (1)

• percentage of adverse effects after OC-IgT cells injection

  To assess the safety of autologous OC-IgT 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 OC-IgT generation

  up to one month

• Ability of OC-IgT cells to induce anti-ovarian cancer reaction

  after 1 month from OC-IgT cells infusion until 12 months after infusion

• Ability of OC-IgT cells for anti-ovarian cancer reaction

  after 1 month from OC-IgT cell infusion until 24 months after infusion

Study Arms (1)

Single arm

EXPERIMENTAL

OC-IgT cells to treat ovarian cancer.

Biological: OC-IgT cells

Interventions

OC-IgT cells BIOLOGICAL

Autologous human OC-IgT cells.

Single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written, informed consent obtained prior to any study-specific procedures.
• Female patients ≥ 20 years.
• Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2.
• Life expectancy ≥ 3 months.
• Able to comply with the protocol.
• Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.
• Complete remission after salvage treatment for first recurrence.
• 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.
• 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:

• Patients with:
• Non-epithelial ovarian cancer.
• Ovarian tumors with low malignant potential (i.e. borderline tumors).
• Synchronous primary endometrial carcinoma and ovarian cancer. 2.Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
• Previous experience of gene-engineered T cell therapy 4.Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
• 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.Inadequate bone marrow function:
• ·Absolute neutrophil count \< 1.0 x 109/L.
• Platelet count \< 100 x 109/L.
• Hb \< 9 g/dL. 8. 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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Lung-Ji Chang, PhD

  Shenzhen Geno-Immune Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86 0755-86573763; c@szgimi.org

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: June 4, 2017
• First Posted: June 14, 2017
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)