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Recruiting
NCT07543055
A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostate Cancer That Has Returned, is Resistant to Treatment and Has Spread
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 36
Sponsor: Regeneron Pharmaceuticals
Location: John Theurer Cancer Center Hackensack New Jersey
Summary
This study will test a study drug called BPX-601, a CAR-T cell product manufactured from the patient's own T-cells, to see if it can help treat advanced prostate cancer. BPX-601 is a drug that is only used in clinical studies.
The study is looking at:
* What side effects BPX-601 might cause
* What is the best dose of BPX-601
* How well BPX-601 may work to destroy prostate cancer
Eligibility Criteria
Key Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma
2. Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening, as defined in the protocol
3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting \[in addition to Androgen Deprivation Therapy (ADT)\] including at least 1 second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
4. Has had either orchiectomy OR is on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \5 × ULN, if liver metastases, and/or total bilirubin \>1.5 × ULN, as described in the protocol
5. Inadequate bone marrow function defined by Absolute Neutrophil Count (ANC) \
Source: ClinicalTrials.gov (NCT07543055). StuddyBuddy aggregates publicly available trial information.