Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)
Overview
- Phase
- Phase 1
- Intervention
- OC-IgT cells
- Conditions
- Ovarian Cancer
- Sponsor
- Shenzhen Geno-Immune Medical Institute
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- percentage of adverse effects after OC-IgT cells injection
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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).
Detailed Description
Ovarian cancer (OC) is a cancer that forms in or on an ovary. The majority of OC arises from the epithelium (outer lining) of the ovary. In 2015 OC was found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for OC consists of surgery, chemotherapy, radiotherapy and sometimes, novel immunotherapies. The best treatment options depend on many factors, including the type of OC, its stage and grade, as well as the general health of the patient. Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. Novel chimeric antigen receptor gene modified T cell (CART) based immunotherapy has demonstrated great successes in B cell malignancies. Here, the study aim is to evaluate the safety and efficacy of genetically engineered OC-specific and immune modulatory T cells in patients. The primary study objectives are to evaluate the safety of the investigational product, autologous OC-IgT cells, to subjects by IV and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous OC-IgT cells in vitro, and (2) to determine the anti-OC efficacy of the OC-IgT cells.
Investigators
Lung-Ji Chang
Principal Investigator
Shenzhen Geno-Immune Medical Institute
Eligibility Criteria
Inclusion Criteria
- •Written, informed consent obtained prior to any study-specific procedures.
- •Female patients ≥ 20 years.
- •Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or
- •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/mm
- •·Platelets ≥100,000/mm
Exclusion Criteria
- •1.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.
- •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.Inadequate bone marrow function:
- •·Absolute neutrophil count \< 1.0 x 109/L.
- •Platelet count \< 100 x 109/L.
- •Hb \< 9 g/dL.
Arms & Interventions
Single arm
OC-IgT cells to treat ovarian cancer.
Intervention: OC-IgT cells
Outcomes
Primary Outcomes
percentage of adverse effects after OC-IgT cells injection
Time Frame: up to one month
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.
Secondary Outcomes
- 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)