Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Purpose

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.

Condition

  • Rheumatoid Arthritis

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body mass index (BMI) <35 kg/m^2, inclusive - Adult-onset, moderate-to-severe rheumatoid arthritis (RA) - Moderate-to-severe active disease - b/tsDMARD failure criterion (≥2) - Swollen joint count ≥4 - Clinical and/or ultrasound evidence of synovitis - Prior inadequate response to or unable to tolerate available RA therapies - Stable doses of RA medications for at least 30 days - Use of highly effective methods of contraception

Exclusion Criteria

  • Major surgery within 12 weeks prior to screening or planned within 12 months after dosing - Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease - Recurrent infections or active infection - Active or untreated latent tuberculosis - Primary or secondary immunodeficiency - History of or current inflammatory joint disease other than RA

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Single Ascending Dose Cohorts (Cohorts 1-3) Split-Dose Cohort (Cohort 4)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 - SBT777101 Dose 1 		Low dose SBT777101
  • Biological: SBT777101
    Experimental treatment
Experimental
Cohort 2 - SBT777101 Dose 2 		Mid dose SBT777101
  • Biological: SBT777101
    Experimental treatment
Experimental
Cohort 3 - SBT777101 Dose 3 		High dose SBT777101
  • Biological: SBT777101
    Experimental treatment
Experimental
Cohort 4 - SBT777101 Split-Dose Administration 		Participants receive two intravenous infusions of SBT777101 derived from a single manufacturing process. Total administered dose ranges from approximately 300 million to 900 million CAR+ Treg cells, divided across two administrations.
  • Biological: SBT777101
    Experimental treatment

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Daniella Cook
617-726-3914
dtcook@mgh.edu

More Details

Status
Recruiting
Sponsor
Sonoma Biotherapeutics, Inc.

Study Contact

Sabrina Fox-Bosetti, MPH
415-992-6245
clinicaloperations@sonomabio.com

Detailed Description

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.