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

Part of paid clinical trials in Redwood City, California.

Sponsor
Adicet Therapeutics
Study ID
NCT07793435
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADI-212 — DRUG
    Allogeneic cell therapy
  • Fludarabine — DRUG
    Chemotherapy for Lymphodepletion
  • Cyclophosphamide — DRUG
    Chemotherapy for Lymphodepletion

Study Details

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)

Key Dates

First listed
Aug 28, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

The incidence of Subjects with Dose Limiting Toxicity within each dose level [ Time Frame: Day 42 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Adicet TherapeuticsRedwood CityCalifornia94065-

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Adicet Therapeutics· Redwood City, CA