A Basket Study of CTA313 in Participants With Active Autoimmune Diseases (ALLNEW)

Key Inclusion Criteria:

• Male or female, ≥ 18 and ≤ 75 years of age
• Adequate organ function

• Diagnosed with one of the following in addition to meeting disease-specific criteria:

  1. Refractory Systemic Lupus Erythematosus (SLE) defined as an inadequate response to at least two immunomodulatory agents and one biologic agent
  2. Primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)
  3. Autoimmune Encephalitis (AIE)

Key Exclusion Criteria:

• Coexisting autoimmune diseases that could interfere with the attribution of disease activity or pose an increased safety risk

• Participants with the following cardiac conditions are excluded:

  1. History of heart failure New York Heart Association (NYHA) class III or IV;
  2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
• History of severe central nervous system (CNS) disorders that could compromise the participant's ability to comply with protocol requirements or interfere with the accuracy of study assessments
• Current or prior malignancy unless the malignancy was treated with curative intent and the subject has no known active malignant disease present for ≥ 5 years before enrollment
• Primary immune deficiency
• Presence of uncontrolled infections
• History of untreated hepatitis C virus, or syphilis
• History of HIV infection, or active or latent hepatitis B virus (HBV) infection.
• Evidence of active Epstein-Barr virus (EBV), cytomegalovirus (CMV) or tuberculosis (TB)
• History of prior CAR-T cell therapy or any other genetically modified immune cell therapy
• Having received live/attenuated vaccine within 4 weeks prior to enrollment
• Participants with a history of hypersensitivity to tacrolimus
• Those who have participated in other interventional clinical trials within 30 days before enrollment
• Participants who meet disease-specific exclusionary criteria as specified