Prostate Cancer
Conditions
Keywords
Relapsed/Refractory (R/R), Metastatic, Castration-Resistant
Brief 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
Interventions
GENETICBPX-601
Administered per protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 \<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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Adverse Events of Special Interest (AESIs) | Up to 4 years |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to 4 years |
| Occurrence of Dose Limiting Toxicities (DLTs) | Up to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manufacturing feasibility of BPX-601 | Up to 4 years | Determination of the feasibility of manufacturing BPX-601 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion |
| Objective response | Up to 4 years | — |
| Disease control | Up to 4 years | — |
| Duration of Response (DoR) | Up to 4 years | — |
| ≥50% reduction in Prostate-Specific Antigen (PSA50) response | Up to 4 years | — |
| PSA90 response | Up to 4 years | — |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed