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A Basket Study of CTA313 in Participants With Active Autoimmune Diseases

NCT07783269 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-08-24

No results posted yet for this study

Summary

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.

Conditions

  • Systemic Lupus Erthematosus (SLE)
  • Progressive Multiple Sclerosis (PMS)
  • Autoimmune Encephalitis

Interventions

DRUG

CTA313 UCAR T Cell Infusion

CAR T cells

Sponsors & Collaborators

  • Imviva Bio

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2029-06-30
Completion
2029-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783269 on ClinicalTrials.gov