Clinical trial NCT06913608: A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases
Official title: A Phase lb Open-Label Study Evaluating the Safety and Efficacy of the Combination of CLBR00l, an Engineered Autologous T Cell Product, and SWI019, a CD19-directed Antibody-based Biologic With or Without Lymphodepletion in Subjects With Autoimmune Disorders Including Systemic Lupus Erythematosus, Systemic Sclerosis, or Idiopathic Inflammatory Myositis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus (SLE)
Systemic Sclerosis (SSc)
Idiopathic Inflammatory Myopathy (IIM)
Keywords: CAR-T
systemic lupus erythematosus
systemic sclerosis
idiopathic inflammatory myopathy
SLE
IIM
SSc
cell therapy
Lead sponsor: Calibr, a division of Scripps Research
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate CLBR001 and SWI019 as a treatment for patients with autoimmune disorders, including systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myositis. Patients will be randomized 1:1 lymphodepletion vs no lymphodepletion arm. Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019 with regular assessments of safety and disease response to treatment.

The goals are to establish the safety and efficacy of the combination therapy and determine if lymphodepletion is required for efficacy.

Detailed description: CLBR001 + SWI019 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR (chimeric antigen receptor)-T product (CLBR001, the switchable CAR-T cell \[sCAR-T\]) and SWI019 (the "switch" biologic molecule). SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.

Eligibility criteria: Inclusion Criteria:

* Women or men age ≥18 of age at time of consent.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of this study.
* Adequate hematological, liver, pulmonary, and cardiac function
* Willing to participate to participate in long term follow up study.
* Confirmed diagnosis of moderate to severe systemic lupus erythematosus with lupus nephritis, systemic lupus erythematosus with extrarenal lupus, systemic sclerosis, and idiopathic inflammatory myositis.
* Failed at least two immunosuppressive treatments

Exclusion Criteria:

* Inability to tolerate washout of prior therapy.
* Not willing/understanding the requirements of the clinical study
* Dependent on hemodialysis for a period of greater or equal to 3 months.
* Known hypersensitivity to prednisone or to both tocilizumab siltuximab.
* Have received plasmapheresis within 14 days prior to informed consent.
* Active bacterial, viral and/or fungal infection.
* Prior autologous/allogeneic stem cell transplant or solid organ transplant.
* Prior lentiviral or retroviral based therapy including CAR-T cell therapy.
* History or concurrent malignancy with active treatment in the past 5 years
* HIV-1 and HIV-2 antibody positive subjects.
* History of central nervous system diseases (such as seizure, psychosis, organic brain syndrome or cerebrovascular accident).

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: To 1 year post CLBR001 administration
Secondary outcomes:
measure: Evaluate the efficacy of CLBR001 + SWI019 in autoimmune disease
timeFrame: 1 year post CLBR001 administration
measure: Quantification of white blood cells (WBCs)
timeFrame: 1 year post CLBR001 administration
measure: Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Maximum Concentration (Cmax)
timeFrame: 1 year post CLBR001 administration
measure: Assess immunogenicity of CLBR001 and SWI019
timeFrame: 1 year post CLBR001 administration
measure: Number of subjects with Clinical Response
timeFrame: 1 year post CLBR001 administration
measure: Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Time to Peak Drug Concentration (Tmax)
timeFrame: 1 year post CLBR001 administration
measure: Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Area Under the Curve (AUC)
timeFrame: 1 year post CLBR001 administration
measure: Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Half-life (t1/2)
timeFrame: 1 year post CLBR001 administration
Other outcomes:
Locations:
Study officials:
affiliation: Calibr-Skaggs, Institute of Innovative Medicines
name: Chan Beals, MD, PhD
role: STUDY_DIRECTOR
References: