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

NCT06375993 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-19

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

ADI-001

Anti-CD20 CAR-T

DRUG

Fludarabine

Chemotherapy for Lymphodepletion

DRUG

Cyclophosphamide

Chemotherapy for Lymphodepletion

Sponsors & Collaborators

  • Adicet Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375993 on ClinicalTrials.gov