ClinicalTrials.gov record NCT07783269

A Basket Study of CTA313 in Participants With Active Autoimmune Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old to 75 years old
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase 1, open-label study tests a single infusion of CTA313 UCART (CAR T cells) in people with active SLE, progressive MS (pMS), or autoimmune encephalitis. Early dose-confirmation cohorts will be evaluated for safety and to set a recommended phase 2 dose, followed by a cohort expansion to gather further safety and preliminary efficacy data. Participants are followed for up to 24 months and must enroll in a separate long-term follow-up protocol for up to 15 years.

What it is studying. The study is testing the safety, tolerability, and preliminary efficacy of one infusion of CTA313 UCART in people with active SLE, pMS, or autoimmune encephalitis. It also aims to determine a recommended phase 2 dose (RP2D) using safety, pharmacokinetic/pharmacodynamic, and early efficacy data, and to characterize the cellular pharmacokinetic profile of CTA313 (expansion, distribution, and persistence).

What the researchers hope to learn. To evaluate the safety profile and dose-limiting toxicities of CTA313; to determine a recommended phase 2 dose based on safety, PK/PD, and early efficacy; to collect preliminary efficacy data for SLE, pMS, and AIE; and to characterize CTA313 cellular pharmacokinetics (expansion, distribution, persistence).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • CTA313 UCAR T Cell Infusion

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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:
  • 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)
  • 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:
  • 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
  • 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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive a single infusion of the investigational CTA313 UCAR T cell product on Day 0. They will be followed in the study for up to 24 months and are required to enroll in a separate long-term follow-up protocol for up to 15 years. The study includes a dose-confirmation stage and a cohort-expansion stage to evaluate safety, determine the recommended phase 2 dose (RP2D), and characterize cellular pharmacokinetics (how the infused cells expand, distribute, and persist). The registry record does not list other specific procedures or tests; the study team will perform the safety and efficacy assessments needed during planned visits.

How the study is structured. Interventional, single-group, open-label Phase 1 study. Participants receive one infusion of CTA313 UCART on Day 0. The study includes a dose-confirmation portion (cohorts evaluated for safety and RP2D) and a cohort expansion portion to further evaluate safety and preliminary efficacy. Participants are followed for up to 24 months in this study; a separate long-term follow-up protocol covers up to 15 years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
December 2026 (estimated)
Primary completion
June 2029 (estimated)
Study completion
September 2029 (estimated)
Target enrollment
81 participants (estimated)
Last updated on registry
Aug 24, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Imviva Bio

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

RP2D
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
Cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
follow up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
CAR-T
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Key Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials