NCT03184753 Genetically Modified T Cells Against Ovarian Cancer
| NCT ID | NCT03184753 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-05-01 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: 1. Written, informed consent obtained prior to any study-specific procedures. 2. Female patients ≥ 20 years. 3. 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. * Complete remission after salvage treatment for first recurrence. 7. Not pregnant, and on appropriate birth control if of childbearing potential. 8. 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 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. 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. 9\. 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.
Contact & Investigator
Lung-Ji Chang, PhD
PRINCIPAL INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Frequently Asked Questions
Who can join the NCT03184753 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03184753 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03184753 currently recruiting?
Yes, NCT03184753 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT03184753 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT03184753 clinical trial?
NCT03184753 is sponsored by Shenzhen Geno-Immune Medical Institute. The principal investigator is Lung-Ji Chang, PhD at Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 100 participants.
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