Prostate Cancer MetastaticPhase 1/2NCT07793435
A Phase 1/2 Trial of ADI-212 in mCRPC
A Phase 1/2 study testing ADI-212, Fludarabine and Cyclophosphamide in people with Prostate Cancer Metastatic, run by Adicet Therapeutics at 1 site in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- ADI-212, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- PSA progression defined as two increases in PSA measured at least one week apart
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- Soft-tissue progression defined per PCWG3
- Bone disease progression defined per PCWG3
- Evaluable target lesions, per PCWG3
- ECOG of 0 or 1
- Prior therapy :
- Participants must have progressed after at least two prior courses of systemic ADT.
- Participants may have had no more than one course of prior taxane therapy.
- Prio PSMA-targeted radioligand therapy (e.g., Pluvicto) is permitted.
- Prior PARP inhibitor therapy is permitted.
- 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
Who cannot join
- 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:
- Presence of known central nervous system (CNS) metastases
- History of clinically significant infection
- Active malignancy within the past 24 months
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- Any other condition requiring treatment with a prohibited medication, as specified in the protocol
- Prior treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Adicet Clinical Trials
Redwood City, California, 94065
Adicet Medical Director, 650-503-9095, clinicaltrials@AdicetBio.com
About this study
Official title: 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)
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)
- Conditions
- Prostate Cancer Metastatic
- Being tested
- ADI-212, Fludarabine, Cyclophosphamide
- Keywords
- PSMA, mCRPC, Cell therapy, chimeric antigen receptor (CAR) t-cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-212Drug
Allogeneic cell therapy
FludarabineDrug
Chemotherapy for Lymphodepletion
CyclophosphamideDrug
Chemotherapy for Lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | ADI-212 is administered via infusion using the 3 + 3 design starting with three planned dose levels to determine the maximum tolerated dose (MTD or maximum assessed dose (MAD) Receives: Drug: ADI-212; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Expansion | Experimental | Dose Expansion to assess the anti-tumor responses to ADI-212 at the recommended Phase 2 dose (Part 2) Receives: Drug: ADI-212; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Subjects with Dose Limiting Toxicity within each dose level
The primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed Dose (MAD) and Recommended Phase 2 Dose (RP2D)
Measured: Day 42
Proportion of treatment emergent and treatment related Adverse Events
This primary endpoint will be used to determine Overall Response Rate (ORR) per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 per local assessment and Radiographic progression-free survival (rPFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 3+3 Dose Escalation Design
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adicet Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793435
- Sponsor's protocol ID
- ADI-212-001
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07793435
- Acronym / sponsor ID
- ADI-212-001
- Conditions
- Prostate Cancer Metastatic
- Keywords
- PSMA, mCRPC, Cell therapy, chimeric antigen receptor (CAR) t-cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Adicet TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3+3 Dose Escalation Design
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: ADI-212, Drug: Fludarabine, Drug: CyclophosphamideADI-212 is administered via infusion using the 3 + 3 design starting with three planned dose levels to determine the maximum tolerated dose (MTD or maximum assessed dose (MAD) |
| Dose Expansion | Experimental | Drug: ADI-212, Drug: Fludarabine, Drug: CyclophosphamideDose Expansion to assess the anti-tumor responses to ADI-212 at the recommended Phase 2 dose (Part 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (14 listed)
- 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:
- Prior CAR-T therapy
- Clinically significant cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-212Allogeneic cell therapy | Drug | Dose Escalation, Dose Expansion |
| FludarabineChemotherapy for Lymphodepletion | Drug | Dose Escalation, Dose Expansion |
| CyclophosphamideChemotherapy for Lymphodepletion | Drug | Dose Escalation, Dose Expansion |
Primary outcome
The incidence of Subjects with Dose Limiting Toxicity within each dose level
Time frame: Day 42
The primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed Dose (MAD) and Recommended Phase 2 Dose (RP2D)
Proportion of treatment emergent and treatment related Adverse Events
Time frame: 2 years
This primary endpoint will be used to determine Overall Response Rate (ORR) per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 per local assessment and Radiographic progression-free survival (rPFS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADI-212, Fludarabine and Cyclophosphamide in people with Prostate Cancer Metastatic, run by Adicet Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adicet Medical Director (650-503-9095, clinicaltrials@AdicetBio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Subjects with Dose Limiting Toxicity within each dose level (time frame: Day 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.