RECRUITING

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Conditions

SLE SLE (Systemic Lupus)Systemic Lupus Erythematosus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Official Title

A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)

Quick Facts

Study Start:2024-12

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06613360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening. * Presence of one or more of the following autoantibodies documented during screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN. * Active SLE disease, as demonstrated by a SLEDAI total score ≥8 at screening. * Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent. * If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1. * Laboratory parameters including the following: * Absolute lymphocyte count (ALC) ≥0.5 x 109/L * Peripheral CD19+ B cell count ≥25 cells/µL * Absolute neutrophil count (ANC) ≥1.0 x 109/L * Hemoglobin ≥8 g/dL * Platelet count ≥75 x 109/L. * Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL/min/1.73m2 * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN * Serum albumin \>2.8 g/dL * Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.	* Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed. * Considered at high risk for thrombosis. * Rapidly progressive glomerulonephritis, and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol). * Active severe neuropsychiatric/CNS manifestations of SLE. * Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection. * History of splenectomy. * Prior treatment with the following: * Cellular or gene therapy product directed at any target. * Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1. * Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1. * Non-biologic DMARD within 14 days prior to Day 1. * Cyclophosphamide or a biologic immunomodulating therapy during 2 months prior to Day 1. * Live or attenuated vaccine within 28 days prior to screening or during screening. * Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1. * Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB. * Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment.

Inclusion Criteria

Exclusion Criteria

* Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening.
* Presence of one or more of the following autoantibodies documented during screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN.
* Active SLE disease, as demonstrated by a SLEDAI total score ≥8 at screening.
* Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent.
* If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1.
* Laboratory parameters including the following:
* Absolute lymphocyte count (ALC) ≥0.5 x 109/L
* Peripheral CD19+ B cell count ≥25 cells/µL
* Absolute neutrophil count (ANC) ≥1.0 x 109/L
* Hemoglobin ≥8 g/dL
* Platelet count ≥75 x 109/L.
* Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL/min/1.73m2
* Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
* Serum albumin \>2.8 g/dL
* Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.

* Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.
* Considered at high risk for thrombosis.
* Rapidly progressive glomerulonephritis, and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol).
* Active severe neuropsychiatric/CNS manifestations of SLE.
* Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
* History of splenectomy.
* Prior treatment with the following:
* Cellular or gene therapy product directed at any target.
* Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1.
* Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1.
* Non-biologic DMARD within 14 days prior to Day 1.
* Cyclophosphamide or a biologic immunomodulating therapy during 2 months prior to Day 1.
* Live or attenuated vaccine within 28 days prior to screening or during screening.
* Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.
* Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.
* Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment.

Contacts and Locations

Study Contact

Meagan Sardinha

CONTACT

+1 617 410 4650

ClinOps@cullinantx.com

Study Locations (Sites)

Omega Research Orlando, LLC

Orlando, Florida, 32808

United States

Tranquil Clinical Research

Webster, Texas, 77598

United States

Collaborators and Investigators

Sponsor: Cullinan Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-12

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Systemic Lupus Erythematosus

Additional Relevant MeSH Terms

SLE
SLE (Systemic Lupus)