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.
Male or female, ≥ 18 and ≤ 75 years of age
Adequate organ function
Refractory Systemic Lupus Erythematosus (SLE) defined as an inadequate response to at least two immunomodulatory agents and one biologic agent
Primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)
Coexisting autoimmune diseases that could interfere with the attribution of disease activity or pose an increased safety risk
History of heart failure New York Heart Association (NYHA) class III or IV;
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
Single group
CTA313 UCAR T Cell Infusion
DrugCAR T cells
Safety Profile
Incidence and severity of adverse events including dose limiting toxicities
RP2D Determination
Determine the RP2D based on safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy.
Preliminary Efficacy - SLE
Proportion of participants achieving DORIS and LLDAS
Preliminary Efficacy - pMS
Proportion of patients without disability progression as defined by change in EDSS
Preliminary Efficacy - AIE
Proportion of patients achieving functional improvement and/or response by modified Rankin Scale (mRS)
Characterize the cPK profile of CTA313
Evaluate CTA313 cellular pharmacokinetic (PK) by measuring expansion, distribution and persistence
This trial is not recruiting at the moment. You can still explore other options:
