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

Who is this study for? Patients with Ovarian Cancer
What treatments are being studied? fhB7H3.CAR-Ts
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

⁃ \-

Locations
Other Locations
China
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Contact Information
Primary
Liantao Li, M.D., Ph.D.
liliantao@xzhmu.edu.cn
+86-516-85582530
Backup
Xin Ding, M.D., Ph.D.
dingxin81@163.com
+86-516-83355832
Time Frame
Start Date: 2021-11-16
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 15
Treatments
Experimental: fhB7H3.CAR-T cells
In phase I study, 9 enrolled patients diagnosed with advanced ovarian cancer will receive one-time infusion of fhB7H3.CAR-Ts at the doses of 1×10\^6/kg, 3×10\^6/kg and 5×10\^6/kg, 3 patients for each dose. To further confirm the therapeutic efficacy, in phase II study, 6 enrolled patients will receive an optimal dose (balancing effectiveness and toxicity) of fhB7H3.CAR-Ts. Prior to receiving the infusions, patients will undergo lymphodepletion with fludarabine and cyclophosphamide.
Related Therapeutic Areas
Sponsors
Collaborators: Xuzhou Medical University, IIT MediTech (Jiangsu) Co. Ltd
Leads: The Affiliated Hospital of Xuzhou Medical University

This content was sourced from clinicaltrials.gov