Prostate CancerPhase 1NCT07543055
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
A Phase 1 study testing BPX-601 in people with Prostate Cancer, run by Regeneron Pharmaceuticals at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- BPX-601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Sep 2026to 27 Jun 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
John Theurer Cancer Center
Hackensack, New Jersey, 07601
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
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
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
- Conditions
- Prostate Cancer
- Being tested
- BPX-601
- Keywords
- Relapsed/Refractory (R/R), Metastatic, Castration-Resistant
- Medical subject headings
- Prostatic Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPX-601Genetic
Administered per protocol
| Study group | Role | What they receive |
|---|---|---|
| BPX-601 monotherapy | Experimental | Not described Receives: Genetic: BPX-601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 4 years
Occurrence of Dose Limiting Toxicities (DLTs)
Measured: Up to Day 28
Occurrence of Adverse Events of Special Interest (AESIs)
Measured: Up to 4 years
Secondary outcomes (6)
Objective response
Measured: Up to 4 years
Duration of Response (DoR)
Measured: Up to 4 years
Disease control
Measured: Up to 4 years
≥50% reduction in Prostate-Specific Antigen (PSA50) response
Measured: Up to 4 years
PSA90 response
Measured: Up to 4 years
Manufacturing feasibility of BPX-601
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
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start8 Sep 2026
- Primary completion2 Feb 2030 (estimated)
- Study completion27 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543055
- Sponsor's protocol ID
- BPX-601-PSA-2540
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07543055
- Acronym / sponsor ID
- BPX-601-PSA-2540
- Conditions
- Prostate Cancer
- Keywords
- Relapsed/Refractory (R/R), Metastatic, Castration-Resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 2 Feb 2030 (estimated)
- Study completion
- 27 Jun 2031 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPX-601 monotherapy | Experimental | Genetic: BPX-601 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPX-601Administered per protocol | Genetic | BPX-601 monotherapy |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPX-601 in people with Prostate Cancer, run by Regeneron Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.