A Basket Study of CTA313 in Participants With Active Autoimmune Diseases (ALLNEW)

August 19, 2026 updated by: Imviva Bio

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTA313 UCAR T Cell Infusion
Drug: CTA313 UCAR T Cell Infusion
CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Profile
Time Frame: 24 months
Incidence and severity of adverse events including dose limiting toxicities
24 months
RP2D Determination
Time Frame: 24 months
Determine the RP2D based on safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary Efficacy - SLE
Time Frame: 24 months
Proportion of participants achieving DORIS and LLDAS
24 months
Preliminary Efficacy - pMS
Time Frame: 24 months
Proportion of patients without disability progression as defined by change in EDSS
24 months
Preliminary Efficacy - AIE
Time Frame: 24 months
Proportion of patients achieving functional improvement and/or response by modified Rankin Scale (mRS)
24 months
Characterize the cPK profile of CTA313
Time Frame: 24 months
Evaluate CTA313 cellular pharmacokinetic (PK) by measuring expansion, distribution and persistence
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imviva Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHCT-CTA313-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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