Posted by Michael Wonder on 08 Apr 2025
Allogene granted three US FDA fast track designations for ALLO-329, a next generation dual targeted CD19/CD70 allogeneic CAR T for the treatment of lupus, myositis and scleroderma
7 April 2025 - Phase 1 RESOLUTION trial initiation planned for mid-2025 with initial proof of concept by year end 2025
Allogene Therapeutics today announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three fast track designations from the US FDA for the treatment of adult patients with:
- Active refractory moderate-to-severe systemic lupus erythematous
- Active severe/refractory idiopathic inflammatory myopathy, specifically dermatomyositis, immune mediated necrotising myopathy and anti-synthetase syndrome
- Active refractory diffuse systemic sclerosis
