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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BPX-601 monotherapy
  • Genetic: BPX-601
    Administered per protocol

Recruiting Locations

John Theurer Cancer Center
Hackensack, New Jersey 07601

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.