A Basket Study of CTA313 in Participants With Active Autoimmune Diseases

Study acronym: ALLNEW
StatusNot Yet Recruiting
PhasePhase 1
SponsorImviva Bio
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Imviva Bio
2 trials monitored
See all monitored trials
Multiple Sclerosis
1,018 trials monitored
See 34 trials at risk
Lupus (SLE)
667 trials monitored
See 27 trials at risk
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.
Trial Details
NCT Number NCT07783269
Lead Sponsor Imviva Bio
Conditions
(from sponsor)		 Systemic Lupus Erthematosus (SLE), Progressive Multiple Sclerosis (PMS), Autoimmune Encephalitis
Related terms Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Chronic Progressive
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov