Using fully human B7H3 CAR-T cells to treat recurrent ovarian cancer
A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of Fully Human B7H3 CAR-T in Treating Patients With Recurrent Malignant Ovarian Cancer
This study is testing a new type of CAR-T cell therapy made from fully human cells to see if it can help people with recurrent ovarian cancer that has the B7H3 marker.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University Academic / other |
| Drugs / interventions | prednisone, CAR-T, Rituximab, chimeric antigen receptor, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Xuzhou, Jiangsu) |
| Trial ID | NCT05211557 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of fully human B7H3 CAR-T cells in patients with recurrent malignant ovarian cancer. It employs a single-center, open-label, phase I/II design with a dose escalation approach to determine the optimal dosage. Patients will undergo lymphodepletion chemotherapy before receiving the CAR-T cell infusion, and their response will be monitored through regular follow-ups and assessments of tumor markers. The study aims to provide a novel treatment option for patients with B7H3-positive ovarian cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with recurrent or refractory ovarian cancer who have confirmed B7H3 expression in their tumor tissue.
Not a fit: Patients without B7H3 expression in their tumors or those with non-recurrent ovarian cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent ovarian cancer that is resistant to standard therapies.
How similar studies have performed: While CAR-T therapies have shown promise in other cancers, this specific approach targeting B7H3 in ovarian cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production
2. Written informed consent and authorization for release of personal health information
3. Subject has adequate performance status as defined by ECOG score of ≤ 2.
4. Expected life expectancy is no less than 12 weeks.
5. Subjects must have histologically or cytologically confirmed ovarian cancer. And cancer tissue or ascitic cancer cells are measured positive for B7H3 expression.
6. Subjects must have recurrent or refractory disease after or during first-line treatment.
Defined as:
Radiographic progression or Continuous Elevation of CA125.
7. Subjects must have evaluable disease - defined as:
Measurable disease with tumor length ≥ 10mm or enlarged lymph nodes ≥ 15mm according to RECIST v1.1 criteria.
8. Adequate organ function - defined as:
1. Blood routine:
white blood cell count ≥ 3 × 10\^9 / L; neutrophil count ≥ 1.5 × 10\^9 / L; hemoglobin ≥ 9g/dL; platelet count ≥ 80 × 10\^9 / L; INR\< 1.5 × ULN; PT, APTT\< 1.5 × ULN
2. The liver, kidney, lung and cardiopulmonary function:
Urea and serum creatinine ≤ 1.5 × ULN; Left ventricular ejection fraction ≥ 40%; Baseline oxygen saturation ≥ 95%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN.
9. Not pregnant with negative serum pregnancy test within 3 days prior to enrollment.
10. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of highly effective methods of contraception from the time of informed consent until 8 weeks after study treatment discontinuation.
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Exclusion Criteria:
1. Subject has primary immunodeficiency syndrome or history of severe allergic reaction.
2. Subject has active infection with HIV, HTLV, HBV, HCV.
3. Subject has severe, uncontrolled intercurrent bacterial, viral or fungal infection.
4. Subject has a history of gastrointestinal perforation, clinical and/or radiographic evidence of bowel obstruction, or intra-abdominal abscess within 3 months prior to starting treatment.
5. Subject has active malignancy under treatment other than ovarian cancer.
6. Subject has Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention.
7. Subject is current using of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent.
8. Subject has not recovered from toxicity of previous anti-tumor treatment (CTCAE 5.0).
9. Subject is pregnant or breastfeeding.
10. Unwilling or unable to provide consent/assent for participation in the study. -
Where this trial is running
Xuzhou, Jiangsu
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Longzhen Zhang, M.D., Ph.D. — The Affiliated Hospital of Xuzhou Medical University
- Study coordinator: Liantao Li, M.D., Ph.D.
- Email: liliantao@xzhmu.edu.cn
- Phone: +86-516-85582530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.