Can engineered immune cells take down treatment-resistant prostate cancer?

NCT ID NCT07793435

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This trial tests ADI-212, a type of cell therapy made from donor immune cells engineered to recognize and attack prostate cancer cells that carry a protein called PSMA. The study enrolls adults with metastatic castration-resistant prostate cancer, a form of the disease that has spread and no longer responds to hormone therapy. Participants receive the cell therapy after a short course of chemotherapy to prepare the body. The trial aims to find the safest dose and to see whether the treatment can shrink tumors or slow the cancer's growth.

What this could mean

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

Active substance
ADI-212, an engineered allogeneic gamma-delta CAR T cell therapy targeting PSMA, given after lymphodepleting chemotherapy
What this could lead to
If it works, this could point toward a durable treatment option for metastatic prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early-phase trial with only 12 participants, so the therapy may not work or may cause severe side effects, including immune reactions or organ damage.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 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

Oct 2029

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.

Inclusion Criteria: * Histologic and/or cytologic confirmation of adenocarcinoma of the prostate * Documented evidence of metastatic disease. * Target lesions must be PSMA-avid by PET/CT, based on local determination. * Must have castration testosterone level (\< 50 ng/dL) and must remain on androgen deprivation therapy (ADT) to maintain this level. * Progressive mCRPC based on at least one of the following: 1. PSA progression defined as two increases in PSA measured at least one week apart 2. Soft-tissue progression defined per PCWG3 3. Bone disease progression defined per PCWG3 * Evaluable target lesions, per PCWG3 * ECOG of 0 or 1 * Prior therapy : 1. Participants must have progressed after at least two prior courses of systemic ADT. 2. Participants may have had no more than one course of prior taxane therapy. 3. Prio PSMA-targeted radioligand therapy (e.g., Pluvicto) is permitted. 4. Prior PARP inhibitor therapy is permitted. 5. Must have prior therapy washout, including investigational agents, of at least three weeks for prior systemic therapies other than androgen deprivation therapies, or five half-lives if the duration is shorter than three weeks. * Adequate BP, hematological, and organ function Exclusion Criteria: * Prior radiation therapy within 21 days prior to start of study treatment * Prior positive superscan results \[i.e.: an imaging appearance on a Tc-99m diphosphonate bone scan\] * Current or history of any of the following conditions or treatments: 1. Presence of known central nervous system (CNS) metastases 2. History of clinically significant infection 3. Active malignancy within the past 24 months 4. Any other condition requiring treatment with a prohibited medication, as specified in the protocol 5. Prior treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy 6. Prior PSMA-targeted therapies other than a single course of a PSMA-targeted radioligand therapy * Prior CAR-T therapy * Clinically significant cardiovascular disease * Prior solid organ transplant * Unwilling to participate in an extended safety monitoring period * Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

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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

    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

  • Adicet Therapeutics

    Redwood City, California, 94065, United States

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