Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Ovarian Cancer

In brief

This is single center, open-label phase I, non-randomized study which will enroll patients with recurrent advanced ovarian cancer to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells (fhB7H3.CAR-Ts) via using a '3+3+3' dose escalation design. In the dose expansion cohort, six patients will be enrolled to further assess their efficacy with the optimal dosage.

Key facts

Study ID

NCT05211557

Run by

The Affiliated Hospital of Xuzhou Medical University

People needed

15

Starts

2021-11-16

Expected to finish

2026-08-31

Last updated by the study team

2022-01-27

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production
• Written informed consent and authorization for release of personal health information
• Subject has adequate performance status as defined by ECOG score of ≤ 2.
• Expected life expectancy is no less than 12 weeks.
• Subjects must have histologically or cytologically confirmed ovarian cancer. And cancer tissue or ascitic cancer cells are measured positive for B7H3 expression.
• Subjects must have recurrent or refractory disease after or during first-line treatment.
• Defined as:
• Radiographic progression or Continuous Elevation of CA125.
• Subjects must have evaluable disease - defined as:
• Measurable disease with tumor length ≥ 10mm or enlarged lymph nodes ≥ 15mm according to RECIST v1.1 criteria.
• Adequate organ function - defined as:
• 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
• 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.
• Not pregnant with negative serum pregnancy test within 3 days prior to enrollment.
• 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.

You may not qualify if…

• Subject has primary immunodeficiency syndrome or history of severe allergic reaction.
• Subject has active infection with HIV, HTLV, HBV, HCV.
• Subject has severe, uncontrolled intercurrent bacterial, viral or fungal infection.
• 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.
• Subject has active malignancy under treatment other than ovarian cancer.
• Subject has Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention.
• Subject is current using of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent.
• Subject has not recovered from toxicity of previous anti-tumor treatment (CTCAE 5.0).
• Subject is pregnant or breastfeeding.
• Unwilling or unable to provide consent/assent for participation in the study. -

Where it is running

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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