Actively Recruiting
Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2022-01-27
15
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor
X
Xuzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Autologous peripheral blood mononuclear cells are suitable for T-cell production
- Written informed consent and permission to release personal health information
- ECOG performance status of 2 or less
- Expected life expectancy of at least 12 weeks
- Histologically or cytologically confirmed ovarian cancer with positive B7H3 expression in tumor tissue or ascitic cancer cells
- Recurrent or refractory disease after or during first-line treatment, defined by radiographic progression or continuous elevation of CA125
- Measurable disease with tumor length at least 10 mm or lymph nodes enlarged at least 15 mm according to RECIST v1.1
- Adequate organ function including specified blood counts, liver, kidney, lung, and heart functions
- Negative serum pregnancy test within 3 days prior to enrollment
- Female subjects of childbearing potential willing to abstain from heterosexual activity or use two forms of contraception from consent until 8 weeks after treatment ends
You will not qualify if you...
- Primary immunodeficiency syndrome or history of severe allergic reaction
- Active infection with HIV, HTLV, HBV, or HCV
- Severe, uncontrolled bacterial, viral, or fungal infection
- History of gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 3 months before treatment
- Active malignancy under treatment other than ovarian cancer
- Grade 3 or higher cardiac dysfunction or symptomatic arrhythmia needing intervention
- Current use of systemic corticosteroids at doses of 10 mg prednisone daily or equivalent
- Not recovered from toxicity of previous anti-tumor treatment (CTCAE 5.0)
- Pregnant or breastfeeding
- Unable or unwilling to provide consent for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Actively Recruiting
Research Team
L
Liantao Li, M.D., Ph.D.
CONTACT
X
Xin Ding, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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