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Engineered immune cells injected directly into prostate tumors: a new hope?

NCT ID NCT07240857

Disease control Sponsor: Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new treatment for castration-resistant prostate cancer (CRPC), a type that no longer responds to standard hormone therapy. Researchers are injecting specially engineered immune cells (CAR-T cells) directly into the prostate or tumor site, after a short course of chemotherapy. The study will enroll 18 people to check if the treatment is safe and whether it can lower PSA levels, a marker of prostate cancer activity.

What this could mean

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

Active substance
ACT#001-PSMA CAR-T 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 hormone therapy.
What could go wrong
This is a very early, small trial (18 people) focused mainly on safety. The treatment may not shrink tumors or improve survival, and there are risks from chemotherapy and CAR-T cell 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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 18 people

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

Started

Apr 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Anyone

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.

Inclusion Criteria 1. understanding of this study and voluntarily signs the informed consent form; 2. Aged ≥ 18 years; 3. Expected survival time of at least 3 months; 4. non-metastatic CRPC (nmCRPC) (local recurrence) or metastatic CRPC (mCRPC)； 5. continue GnRH analog therapy； 6. at least one evaluable lesion per RECIST 1.1; 7. Has received at least one type of novel endocrine therapy； 8. PSMA positive expression rate \> 10%; 9. Eastern Cooperative Oncology Group (ECOG) 0-1; 10. Well organ function 11. Left Ventricular Ejection Fraction (LVEF) \> 50%; 12. Oxygen saturation \> 92% without oxygen supplementation; 13. agree to use effective contraceptive measures Exclusion Criteria 1. Presence of brain metastasis; 2. Organ transplantation or pending organ transplantation; 3. Uncontrolled large-volume serous cavity effusions； 4. A history of autoimmune diseases； 5. A history of receiving other cell therapies or genetically modified cell therapies (e.g., TCR-T therapy, CAR-T therapy); 6. A history of receiving any PSMA-targeted therapy; 7. Requirement for steroid therapy (except for physiological replacement therapy); 8. A history of receiving immunotherapies; 9. A history of clinically significant central nervous system (CNS) diseases (either past or present at screening); (12) A history of other untreated malignant tumors; (13) Participants with severe cardiovascular diseases; (14) Active infectious diseases; (15) Active hepatitis B or hepatitis C virus infection; (16) Active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection (17) Intolerance or allergy to cyclophosphamide or fludarabine chemotherapeutic drugs; (18) No accessible injection sites; (19) Assessment by the investigator that the participant is unsuitable for participation in this clinical study.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma

As listed by the trial registrant

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

Castration-resistant prostate cancer (CRPC)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.