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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
CAR T cells
Safety Profile
Incidence and severity of adverse events including dose limiting toxicities
Time frame: 24 months
RP2D Determination
Determine the RP2D based on safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy.
Time frame: 24 months
Preliminary Efficacy - SLE
Proportion of participants achieving DORIS and LLDAS
Time frame: 24 months
Preliminary Efficacy - pMS
Proportion of patients without disability progression as defined by change in EDSS
Time frame: 24 months
Preliminary Efficacy - AIE
Proportion of patients achieving functional improvement and/or response by modified Rankin Scale (mRS)
Time frame: 24 months
Characterize the cPK profile of CTA313
Evaluate CTA313 cellular pharmacokinetic (PK) by measuring expansion, distribution and persistence
Time frame: 24 months
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