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

NCT07793435 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ADI-212-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  2 years

Study Arms (2)

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)

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)

Drug: ADI-212; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

ADI-212 DRUG

Allogeneic cell therapy

Dose Escalation; Dose Expansion

Fludarabine DRUG

Chemotherapy for Lymphodepletion

Dose Escalation; Dose Expansion

Cyclophosphamide DRUG

Chemotherapy for Lymphodepletion

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Includes cisgender men and transgender men (assigned male at birth, identify as male).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Adicet Therapeutics: lead

Study Sites (1)

Adicet Therapeutics

Redwood City, California, 94065, United States

Location

MeSH Terms

Interventions

fludarabine; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 Dose Escalation Design

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (1)