Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian (NCT04670068) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian
United States4 participantsStarted 2021-01-27
Plain-language summary
This is single center, open-label phase 1 dose escalation trial that uses modified 3+3 design to identify a recommended phase 2 dose (RP2D) of CAR.B7-H3 T cell product. An expansion cohort will enroll additional subjects at the RP2D for a total enrollment of up to 21 subjects on the protocol.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or their legally authorized representative; subject was given a copy of the informed consent form.
✓. Older than 18 years at the time of consent.
✓. Subject has adequate performance status as defined by ECOG score of ≤ 2.
✓. Subjects must have histologically or cytologically confirmed epithelial ovarian, peritoneal or fallopian tube cancer and must have a histological diagnosis of high-grade serous histology based on local histopathological findings.
✓. Subjects must have recurrent platinum-resistant or platinum-refractory disease defined as:
✓. Disease that has progressed by imaging while receiving platinum OR
✓. Disease that has recurred within 6 months of the last receipt of platinum-based chemotherapy. Rising CA-125 only is not considered as a platinum-resistant or refractory disease.
✓. Having received at least 2 prior regimens.
Exclusion criteria
✕. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated in the study).
✕. Subject is deemed unlikely to be a candidate for successful intraperitoneal catheter placement by radiographic assessment.
✕
What they're measuring
1
Number of Participants With Dose Limiting Toxicities (DLTs) Based on National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE)
Timeframe: Up to 10 weeks (Up 4 weeks after the last CAR-T cell infusion)
2
Number of Participants With Dose Limiting Toxicities (DLTs) Based on Cytokine Release Syndrome (CRS)
Timeframe: Up to 10 weeks (Up 4 weeks after the last CAR-T cell infusion)
3
Number of Participants With Dose Limiting Toxicities (DLTs) Based on Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Timeframe: Up to 10 weeks (Up 4 weeks after the last CAR-T cell infusion)
. Subject has intraparenchymal lung metastases (note that pleural effusions are not exclusionary and that subjects with intraparenchymal liver disease and subjects with the retroperitoneal disease are allowed on the study).
✕. Subject has brain metastases. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to being screened for eligibility, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic.
✕. Subject has current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment.
✕. Subject has a history of an intra-abdominal abscess within the past 3 months.
✕. Subject has a history of gastrointestinal perforation.
✕. The subject has a history of symptomatic diverticular disease, confirmed by CT or colonoscopy.