A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

Phase 2RecruitingNCT07015983

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company89 enrolled

Overview

The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lupus Erythematosus, Systemic Lupus Nephritis

Interventions

CC-97540

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must meet EULAR/ACR 2019 criteria for SLE. * Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. * Participants must have active disease when signing ICF. Exclusion Criteria: * Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE. * Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies. * IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study. * Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant. * Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration. * Participant must not have inadequate organ function. * Other protocol-defined inclusion/exclusion criteria apply.

Locations (96)

Local Institution - 0009

Birmingham, Alabama, United States

NOT_YET_RECRUITING

Local Institution - 0080

Scottsdale, Arizona, United States

WITHDRAWN

Local Institution - 0038

Los Angeles, California, United States

NOT_YET_RECRUITING

Local Institution - 0051

Los Angeles, California, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission

Time frame: At month 6

Secondary Outcomes

Complete renal response (CRR) for participants with baseline lupus nephritis (LN)

Time frame: Up to Month 60

Participants with drug-free DORIS remission

Time frame: Up to month 60

CRR for participants with baseline LN

Time frame: Up to month 60

Modified CRR for participants with baseline LN

Time frame: Up to month 60

Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6

Time frame: Up to month 60

Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6

Time frame: Up to month 60

Number of participants with flares as assessed by SLEDAI flare index

Time frame: Up to month 60

Severity of participants with flares as assessed by SLEDAI flare index

Time frame: Up to month 60

Change from baseline in proteinuria

Time frame: Up to month 60

Change from baseline in estimated glomerular filtration rate (eGFR)

Time frame: Up to month 60

Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC)/ACR (American College of Rheumatology) damage index

Time frame: Up to month 60

Percentage of participants achieving maintenance of drug-free DORIS remission

Time frame: Up to month 60

Percentage of participants achieving maintenance of LLDAS

Time frame: Up to month 60

Percentage of participants achieving maintenance of SRI-4

Time frame: Up to month 60

Time from first response to loss of response for drug-free DORIS remission

Time frame: Up to month 60

Time from first response to loss of response for LLDAS

Time frame: Up to month 60

Time from first response to loss of response for SRI-4

Time frame: Up to month 60

Time from baseline to first drug-free DORIS remission

Time frame: Up to month 60

Time from baseline to LLDAS

Time frame: Up to month 60

Time from baseline to SRI-4

Time frame: Up to month 60

Duration of drug-free status

Time frame: Up to month 60

Percentage of participants achieving DORIS remission regardless of drug-free status

Time frame: Up to month 60

Glucocorticoid used post-infusion for SLE treatment

Time frame: Up to month 60

Change of serum autoantibodies from baseline

Time frame: Up to month 60

Change in complement factor (C3 and C4) levels from baseline

Time frame: Up to month 60

Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue

Time frame: Up to month 60

Change from baseline in PRO as assessed by SF 36 v2 Acute

Time frame: Up to month 60

Change from baseline in PRO as assessed by EQ-5D-5L

Time frame: Up to month 60

Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain

Time frame: Up to month 60

Change from baseline in PRO as assessed by PGI-S Fatigue

Time frame: Up to month 60

Patient Global Impression of Change (PGI-C) Pain

Time frame: Up to month 60

PGI-C Fatigue

Time frame: Up to month 60

Number of participants with Adverse Events (AEs)

Time frame: Up to month 60

Number of participants with serious AEs (SAEs)

Time frame: Up to month 60

Number of participants with AESIs (AEs of Special Interest)

Time frame: Up to month 60

Number of participants with clinically significant laboratory abnormalities

Time frame: Up to month 60

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT