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Experimental CAR t therapy takes on Hard-to-Treat prostate cancer

NCT ID NCT07543055

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 7 times

Summary

This early-stage study tests BPX-601, a personalized CAR T cell therapy made from a patient's own immune cells, for advanced prostate cancer that has spread and stopped responding to other treatments. The trial will enroll 36 people to find the safest dose and check for side effects, while also seeing if the therapy can shrink tumors or lower PSA levels. It is not yet recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BPX-601 (a CAR T cell therapy made from the patient's own immune cells)
What this could lead to
If successful, this could point toward a new treatment option for advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial with only 36 participants, so it is primarily testing safety and dosing. The treatment may not shrink tumors or could cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Providence Portland Medical Center - Oncology

    RECRUITING

    Portland, Oregon, 97213, United States

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