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Not yet recruitingNCT07793435Updated Sep 10, 2026

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

A Phase 1/2 interventional study of ADI-212 and Fludarabine in Prostate Cancer Metastatic, sponsored by Adicet Therapeutics. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Adicet Therapeutics · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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)

02

Conditions studied

  • Prostate Cancer Metastatic

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Keywords

  • PSMA, mCRPC
  • Cell therapy, chimeric antigen receptor (CAR) t-cell therapy
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 12 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Adicet Therapeutics is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologic and/or cytologic confirmation of adenocarcinoma of the prostate
  • Documented evidence of 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
  • 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 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

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)
    2. History of infection
    3. Active 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Dose Escalation

    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)

    Drug: ADI-212 · Drug: Fludarabine · Drug: Cyclophosphamide

  • Experimental
    Dose Expansion

    Dose Expansion to assess the anti-tumor responses to ADI-212 at the recommended Phase 2 dose (Part 2)

    Drug: ADI-212 · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Day 42

  2. 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)

    Time frame: 2 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.

Of 96 industry-sponsored phase 1/2 interventional studies under Prostatic Neoplasms, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35. This study's planned 25 months is below that.

Counting every sponsor, half of 210 studies reached it within 61 months; a quarter within 30 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 28, 2026
StartEst.
Sep 2026
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2029
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793435
Lead sponsor
Adicet Therapeutics
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Sep 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

Adicet Medical Director
Contact
clinicaltrials@AdicetBio.com
650-503-9095

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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