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 2Active Not RecruitingNCT07015983

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-97540DRUG

Specified dose on specified days

FludarabineDRUG

Specified dose on specified days

CyclophosphamideDRUG

Specified dose on specified days

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. * 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 (97)

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)

Data from ClinicalTrials.gov

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Local Institution - 0106

Phoenix, Arizona, United States

Local Institution - 0038

Los Angeles, California, United States

Local Institution - 0051

Los Angeles, California, United States

Local Institution - 0093

Newport Beach, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

Local Institution - 0073

Orlando, Florida, United States

...and 87 more locations

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