Autoimmune Encephalitis, Progressive Multiple Sclerosis (PMS), Systemic Lupus Erthematosus (SLE)
Conditions
Keywords
allogeneic CAR-T Therapy
Brief 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.
Interventions
DRUGCTA313 UCAR T Cell Infusion
CAR T cells
Sponsors
Imviva Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Profile | 24 months | Incidence and severity of adverse events including dose limiting toxicities |
| RP2D Determination | 24 months | Determine the RP2D based on safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary Efficacy - SLE | 24 months | Proportion of participants achieving DORIS and LLDAS |
| Preliminary Efficacy - pMS | 24 months | Proportion of patients without disability progression as defined by change in EDSS |
| Preliminary Efficacy - AIE | 24 months | Proportion of patients achieving functional improvement and/or response by modified Rankin Scale (mRS) |
| Characterize the cPK profile of CTA313 | 24 months | Evaluate CTA313 cellular pharmacokinetic (PK) by measuring expansion, distribution and persistence |
Contacts
CONTACTJan Davidson-Moncada, MD, PhD
Outcome results
None listed