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Purpose

The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Aged 18 to 65 years at the time of consent. 2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria. 3. Active, seropositive disease, with SLEDAI 2K >=8. 4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.

Exclusion Criteria

  1. Active neuropsychiatric SLE. 2. History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation. 3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
This is an open-label study in which subjects will be enrolled into four single-dose ascending cohorts. Each subject's participation will last approximately 198 days, including a 30-day screening period, a 1-day treatment period, and follow-up through Week 24.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Dose Level A
  • Drug: Budoprutug
    Single IV dose of study product on Day 1 of study
    Other names:
    • TNT119
Experimental
Cohort 2: Dose Level B
  • Drug: Budoprutug
    Single IV dose of study product on Day 1 of study
    Other names:
    • TNT119
Experimental
Cohort 3: Dose Level C
  • Drug: Budoprutug
    Single IV dose of study product on Day 1 of study
    Other names:
    • TNT119
Experimental
Cohort 4: Dose Level D
  • Drug: Budoprutug
    Single IV dose of study product on Day 1 of study
    Other names:
    • TNT119

Recruiting Locations

Climb Bio Investigative Site #100101
San Antonio 4726206, Texas 4736286 78215

Climb Bio Investigative Site #100103
Caguas 4563008, Puerto Rico

More Details

Status
Recruiting
Sponsor
Climb Bio, Inc.

Study Contact

Climb Bio Study Director
+1 866 857 2596
clinicaltrials@climbbio.com

Detailed Description

Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b, open-label study will evaluate budoprutug administered as a single intravenous infusion in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time following a single infusion.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.