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A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

ConditionsSjögrenSjogren DiseaseSjogren's Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCullinan Therapeutics Inc.

About this trial

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening.

Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.

Absolute lymphocyte count (ALC) ≥0.5 × 10^9/L

Peripheral CD19+ B cell count ≥25 cells/µL

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • CLN-978

    Drug

    Specified dose on specified days

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Part A Dose EscalationExperimental treatment 1 intervention
Group B: Part B Further Dose EvaluationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability

Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).

Time frame
48 weeks

Secondary outcomes

1

To evaluate the PK of CLN-978

Serum concentrations of CLN-978

Time frame
48 weeks
2

Detection of anti-drug antibodies

Detection of anti-drug antibodies

Time frame
48 weeks
3

Change from baseline in B lymphocyte cell numbers in peripheral blood

B lymphocyte cell numbers and change from baseline in peripheral blood

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cullinan Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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