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Not yet recruitingPhase 1 / Phase 2

A Phase 1/2 Trial of ADI-212 in mCRPC

A Phase 1/2 Trial of ADI-212 (Engineered γδ Chimeric Antigen Receptor [CAR] Vδ1 T Cells Targeting PSMA) in Adults With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is a Phase 1/2 multicenter, open-label, dose finding and dose expansion study of ADI-212 in participants with metastatic castration-resistant prostate cancer (mCRPC)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

CA