BPX-601 CAR T-Cell Therapy for Relapsed, Metastatic Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial evaluating BPX-601, a CAR T-cell product made from the patient’s own T cells, in adults with advanced prostate cancer that has progressed after prior treatments. The study aims to identify a safe dose, characterize side effects, and get an early sense of how well the therapy can reduce cancer activity. Participants receive BPX-601 under close medical supervision with ongoing assessments. The trial may help determine whether this personalized cellular therapy is a viable option for this hard-to-treat population.

Why it matters

Who can join: the full rules

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

Key Exclusion Criteria:

1. Structurally unstable bone lesions suggesting impending fracture
2. Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or other known thromboembolic event that has not been definitively treated. Participants with prior history of coagulopathy must be on low-molecular weight heparin prophylaxis or prophylactic dose of oral anticoagulant and asymptomatic within 4 weeks of the planned BPX-601 infusion
3. Inadequate renal function defined by creatinine clearance \<60 mL/min calculated by 24-hour urine collection or using the Cockcroft-Gault formula
4. Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) \>2.5 × ULN or \>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) \<1.5 × 10\^9/L or platelet count \<150 × 10\^9/L. At least 7 days must have passed since the last dose of filgrastim (or 14 days since the last dose of pegfilgrastim) and at least 7 days must have passed since the last platelet transfusion at the time of ANC or platelet count.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where it's running

• Emory Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• John Theurer Cancer Center
  Hackensack, New Jersey, United States Recruiting
• Providence Portland Medical Center
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.