Lupus Erythematosus, Systemic, Lupus Nephritis
Conditions
Keywords
Lupus, SLE, LN, CAR T, Cell Therapy, CD19 CAR T, CD19, CD19 NEX-T, CD19 NEXT, CD19 NEX T, Zola-cel, Zolacabtagene autoleucel
Brief summary
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.
Interventions
DRUGCC-97540
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission | At month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Complete renal response (CRR) for participants with baseline lupus nephritis (LN) | Up to Month 60 |
| Participants with drug-free DORIS remission | Up to month 60 |
| CRR for participants with baseline LN | Up to month 60 |
| Modified CRR for participants with baseline LN | Up to month 60 |
| Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6 | Up to month 60 |
| Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6 | Up to month 60 |
| Number of participants with flares as assessed by SLEDAI flare index | Up to month 60 |
| Severity of participants with flares as assessed by SLEDAI flare index | Up to month 60 |
| Change from baseline in proteinuria | Up to month 60 |
| Change from baseline in estimated glomerular filtration rate (eGFR) | Up to month 60 |
| Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC)/ACR (American College of Rheumatology) damage index | Up to month 60 |
| Percentage of participants achieving maintenance of drug-free DORIS remission | Up to month 60 |
| Percentage of participants achieving maintenance of LLDAS | Up to month 60 |
| Percentage of participants achieving maintenance of SRI-4 | Up to month 60 |
| Time from first response to loss of response for drug-free DORIS remission | Up to month 60 |
| Time from first response to loss of response for LLDAS | Up to month 60 |
| Time from first response to loss of response for SRI-4 | Up to month 60 |
| Time from baseline to first drug-free DORIS remission | Up to month 60 |
| Time from baseline to LLDAS | Up to month 60 |
| Time from baseline to SRI-4 | Up to month 60 |
| Duration of drug-free status | Up to month 60 |
| Percentage of participants achieving DORIS remission regardless of drug-free status | Up to month 60 |
| Glucocorticoid used post-infusion for SLE treatment | Up to month 60 |
| Change of serum autoantibodies from baseline | Up to month 60 |
| Change in complement factor (C3 and C4) levels from baseline | Up to month 60 |
| Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue | Up to month 60 |
| Change from baseline in PRO as assessed by SF 36 v2 Acute | Up to month 60 |
| Change from baseline in PRO as assessed by EQ-5D-5L | Up to month 60 |
| Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain | Up to month 60 |
| Change from baseline in PRO as assessed by PGI-S Fatigue | Up to month 60 |
| Patient Global Impression of Change (PGI-C) Pain | Up to month 60 |
| PGI-C Fatigue | Up to month 60 |
| Number of participants with Adverse Events (AEs) | Up to month 60 |
| Number of participants with serious AEs (SAEs) | Up to month 60 |
| Number of participants with AESIs (AEs of Special Interest) | Up to month 60 |
| Number of participants with clinically significant laboratory abnormalities | Up to month 60 |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed