A Basket Study of CTA313 in Participants With Active Autoimmune Diseases

A Single-Arm, Open-Label, Multi-Center, Phase Ib Basket Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTA313 in Participants With Active Autoimmune Diseases

The goal of the ALLNEW clinical trial is to learn if CTA313 UCART is safe and effective for patients with immune mediated disorders.

Participants with SLE, pMS and AIE between the ages of 18 and 75 will be eligible to participate.

Participants will receive one infusion of CTA313 on Day 0. During the Dose Confirmation portion, cohorts will be independently evaluated for safety and to establish the RP2D of CTA313. During the Cohort Expansion portion of the study patients will be evaluated to further confirm the efficacy and safety of CTA313.

Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.

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