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BPX-601

Phase 1

Prostate Cancer | Gene therapy | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

BPX-601 · 1 trial · 1 indication

Phase 1 1
NCT07543055A 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 SpreadProstate Cancer
RECRUITING36 Analytics
PHASE1RECRUITING
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
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of Treatment Emergent Adverse Events (TEAEs)
Up to 4 years
Occurrence of Dose Limiting Toxicities (DLTs)
Up to Day 28
Occurrence of Adverse Events of Special Interest (AESIs)
Up to 4 years

Secondary Endpoints

Objective response
Up to 4 years
Duration of Response (DoR)
Up to 4 years
Disease control
Up to 4 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BPX-601 monotherapyEXPERIMENTAL -

Interventions

NameTypeDescription
BPX-601GENETICAdministered per protocol
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites2

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 ...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT07543055primaryCompletionDate: changed
LOWAug 28, 2026NCT07543055primaryCompletionDate: changed
LOWAug 11, 2026NCT07543055startDate: changed
LOWAug 11, 2026NCT07543055startDate: changed
LOWAug 11, 2026NCT07543055startDate: changed
LOWJun 30, 2026NCT07543055Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 30, 2026NCT07543055Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 30, 2026NCT07543055Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about BPX-601

What is BPX-601 used for in prostate cancer?

BPX-601 is an investigational gene therapy being studied for the treatment of prostate cancer that has returned, is resistant to treatment, and has spread. It is currently in Phase 1 clinical development and is not yet approved by the FDA.

Who is developing BPX-601?

BPX-601 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of this investigational therapy.

What phase is BPX-601 in?

BPX-601 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness in patients with prostate cancer.

What clinical trials is BPX-601 in?

BPX-601 is being studied in a Phase 1 clinical trial with the identifier NCT07543055. This trial is recruiting adult male participants with prostate cancer that has returned, is resistant to treatment, and has spread. The study is being conducted in the United States and aims to enroll 36 participants.

Is BPX-601 a CAR T-cell therapy?

Yes, BPX-601 is a CAR T-cell therapy, a type of gene therapy. It is being investigated in a Phase 1 study for the treatment of prostate cancer. The trial is uncontrolled, meaning there is no comparison group, and it is not randomized or double-blinded.