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

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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

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07543055
Protocol IDs
BPX-601-PSA-2540 (primary)
NCI-2026-06250
Study Sponsor
Regeneron Pharmaceuticals, Inc.

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

  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 <50 ng/dL AND agrees to stay on LHRH agonist or antagonist therapy during the study Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.