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

First listed
Apr 19, 2024
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

Related Studies