Can engineered immune cells take down treatment-resistant prostate cancer?
NCT ID NCT07793435
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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.
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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
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Adicet Therapeutics
Redwood City, California, 94065, United States
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