Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Allogeneic ALLO-329, CAR-T cell therapy in autoimmune disease(RESOLUTION)

The study is being conducted in participants with an autoimmune disease, specifically systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), or systemic sclerosis (SSc). The goal is to test if study drug, ALLO-329 CAR T cells can safely reset the immune system and achieve lasting remission of these diseases.


Why this Research Matters

This study is a little over 5 years long. This includes a screening period of upto 28 days and 60 months of follow up.


Who can Participate

Adult

Adults who are 18 years to 70 years old. Participants should have a diagnosis of either SLE, IIM or SSc. SLE:- 1. SLE defined by the Systemic Lupus International Collaborating Clinics(SLICC) criteria. 2. Positive for at least 1 of the autoantibodies- Anti-dsDNA, Anti-Sm, Anti-RNP 3. Active (moderate to severe) disease 4. Disease activity despite prior treatment with standard of care therapy including at least one immunosuppresive agent for at least 2 months. IIM:- 1. Classification of probable or definite dermatomyositis, IMNM or anti-synthetase syndrome 2. Muscle, skin or lung involvement 3. Disease activity despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months SSc:- 1. Within 7 years of first non-Raynaud's presentation (or positive/lung progression AND discussion with EAC) 2. Disease activity despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 2 months Exclusion:- 1. Any known active or prior malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ of the breast, cervix or bladder, or low risk prostate cancer in observation. 2. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy). 3. Received live vaccine within 4 weeks prior to enrollment. 4. History of bone marrow/hematopoetic stem cell or solid organ transplantation.


Study ID

Protocol Number: 25-1323

More information available at ClinicalTrials.gov: NCT07085104


Meet the Team

Image of Principal Investigator

Melissa Griffith, MD

Principal Investigator