A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease

Part of paid clinical trials in Redwood City, California.

Sponsor
Adicet Therapeutics
Study ID
NCT06375993
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • ANCA-Associated Vasculitis (AAV)
  • Autoimmune Diseases
  • Idiopathic Inflammatory Myopathies
  • Lupus Nephritis
  • Stiff Person Syndrome
  • Systemic Lupus Erythematosus (SLE)
  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ADI-001 — DRUG
    Anti-CD20 CAR-T
  • Fludarabine — DRUG
    Chemotherapy for Lymphodepletion
  • Cyclophosphamide — DRUG
    Chemotherapy for Lymphodepletion

Study Details

ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up

Key Dates

Start date
Nov 10, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ADI-001 Dose Escalation
    ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001.
  • Experimental: ADI-001 Dose Extension
    After dose level has been declared safe, additional patients can be enrolled at the declared safe dose to further investigate the safety profile of ADI-001. Dose extension patients will not contribute to the determination of MTD/MAD and DLT evaluation.
  • Experimental: ADI-001 Dose Expansion
    Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).

Primary Outcome Measure

The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort [ Time Frame: 28 Days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Adicet Clinical TrialsRedwood CityCalifornia94065-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-

Find similar trials in Redwood City, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Adicet Clinical Trials· Redwood City, CARoswell Park Comprehensive Cancer Center· Buffalo, NY

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