Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis (Regulate-RA)

Sonoma Biotherapeutics

Status and phase: Enrolling; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: SBT777101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06201416

SBT777101-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) <35 kg/m^2, inclusive
• Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Moderate-to-severe active disease
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

SBT777101 Dose 1

Experimental group

Description:

Low dose SBT777101

Treatment:

Biological: SBT777101

SBT777101 Dose 2

Experimental group

Description:

Mid dose SBT777101

Treatment:

Biological: SBT777101

SBT777101 Dose 3

Experimental group

Description:

High dose SBT777101

Treatment:

Biological: SBT777101