Systemic Lupus Erthematosus (SLE)Phase 1ALLNEWNCT07783269
A Basket Study of CTA313 in Participants With Active Autoimmune Diseases
A Phase 1 study testing CTA313 UCAR T Cell Infusion in people with Systemic Lupus Erthematosus (SLE) and Progressive Multiple Sclerosis (PMS), run by Imviva Bio.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erthematosus (SLE), Progressive Multiple Sclerosis (PMS), Autoimmune Encephalitis
- What is being tested?
- CTA313 UCAR T Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- CTA313 UCAR T Cell Infusion
- Keywords
- allogeneic CAR-T Therapy
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTA313 UCAR T Cell InfusionDrug
CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| CTA313 UCAR T Cell Infusion | Experimental | Not described Receives: Drug: CTA313 UCAR T Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile
Incidence and severity of adverse events including dose limiting toxicities
Measured: 24 months
RP2D Determination
Determine the RP2D based on safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy.
Measured: 24 months
Secondary outcomes (4)
Preliminary Efficacy - SLE
Proportion of participants achieving DORIS and LLDAS
Measured: 24 months
Preliminary Efficacy - pMS
Proportion of patients without disability progression as defined by change in EDSS
Measured: 24 months
Preliminary Efficacy - AIE
Proportion of patients achieving functional improvement and/or response by modified Rankin Scale (mRS)
Measured: 24 months
Characterize the cPK profile of CTA313
Evaluate CTA313 cellular pharmacokinetic (PK) by measuring expansion, distribution and persistence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erthematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm, Phase Ib study to assess the safety and efficacy of CTA313 in participants within 3 immune mediated disorder cohorts through a Dose Confirmation and a Cohort Expansion portion.
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imviva Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783269
- Sponsor's protocol ID
- BHCT-CTA313-101
- Acronym
- ALLNEW
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07783269
- Acronym / sponsor ID
- ALLNEW / BHCT-CTA313-101
- Conditions
- Systemic Lupus Erthematosus (SLE), Progressive Multiple Sclerosis (PMS), Autoimmune Encephalitis
- Keywords
- allogeneic CAR-T Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Imviva BioIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, Phase Ib study to assess the safety and efficacy of CTA313 in participants within 3 immune mediated disorder cohorts through a Dose Confirmation and a Cohort Expansion portion.
| Arm | Type | Receives |
|---|---|---|
| CTA313 UCAR T Cell Infusion | Experimental | Drug: CTA313 UCAR T Cell Infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (16 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTA313 UCAR T Cell InfusionCAR T cells | Drug | CTA313 UCAR T Cell Infusion |
Primary outcome
Safety Profile
Time frame: 24 months
Incidence and severity of adverse events including dose limiting toxicities
RP2D Determination
Time frame: 24 months
Determine the RP2D based on safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy.
4 secondary outcomes
Preliminary Efficacy - SLE
Time frame: 24 months
Preliminary Efficacy - pMS
Time frame: 24 months
Preliminary Efficacy - AIE
Time frame: 24 months
Characterize the cPK profile of CTA313
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTA313 UCAR T Cell Infusion in people with Systemic Lupus Erthematosus (SLE) and Progressive Multiple Sclerosis (PMS), run by Imviva Bio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Davidson-Moncada, MD, PhD (917-573-8538, clinicaltrials@imvivabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Profile (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.