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

Official title

A Phase 1, Open-Label, Dose-Escalation Study of BPX-601, an Anti-PSCA CAR T Cell Drug Product, in Relapsed/Refractory Metastatic Castration-Resistant Prostate Cancer

Overview

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

• Genetic BPX-601
  Administered per protocol

Primary outcome measures

• Occurrence of Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 4 years]
• Occurrence of Dose Limiting Toxicities (DLTs) [Time frame: Up to Day 28]
• Occurrence of Adverse Events of Special Interest (AESIs) [Time frame: Up to 4 years]

Secondary outcome measures (6)

• Objective response [Time frame: Up to 4 years]
• Duration of Response (DoR) [Time frame: Up to 4 years]
• Disease control [Time frame: Up to 4 years]
• ≥50% reduction in Prostate-Specific Antigen (PSA50) response [Time frame: Up to 4 years]
• PSA90 response [Time frame: Up to 4 years]
• Manufacturing feasibility of BPX-601 [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma
• 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
• 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)
• 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

• Structurally unstable bone lesions suggesting impending fracture
• 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
• Inadequate renal function defined by creatinine clearance <60 mL/min calculated by 24-hour urine collection or using the Cockcroft-Gault formula
• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• John Theurer Cancer Center — Hackensack

Identifiers

NCT: NCT07543055 · BPX-601-PSA-2540

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗