RecruitingPhase 1NCT07234773

A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).

A Phase 1a, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT501 by a Single Subcutaneous Administration in Participants With Rheumatoid Arthritis

Sponsor

Kali Therapeutics, Inc.

Enrollment

24 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

Summary

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

to 75 years old
Diagnosis of adult-onset RA for at least 6 months
Moderately to severely active RA
Inadequate treatment response as defined in the protocol
RF + or ACPA+
Stable use of traditional DMARDs is permitted
Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Exclusion Criteria10

Functional class IV as defined by the ACR Classification of Functional Status in RA
Presence of any concomitant autoimmune disease other than RA
Active infection, history of serious recurrent or chronic infection
History of progressive multifocal leukoencephalopathy
Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years.
History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
Receipt of live vaccine within 4 weeks
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study
Women who are pregnant or breastfeeding
Significant or uncontrolled medical disease that would preclude participant participation

Interventions

DRUGKT501

KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.

Locations(1)

Kali Study Site

Bayswater, Australia

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