NCT07783269Not yet recruitingPhase 1
A Basket Study of CTA313 in Participants With Active Autoimmune Diseases
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Imviva Bio
- Diseases
- Multiple sclerosis
- NCT number
- NCT07783269
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 81
- From 1 Dec 2026 to the primary completion date, 30 Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Those who have participated in other interventional clinical trials within 30 days before enrollment
Other illness
- 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
- 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)
- Participants with a history of hypersensitivity to tacrolimus
- Participants who meet disease-specific exclusionary criteria as specified
Age
- 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
Other
- Primary immune deficiency
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.