Study of CC-97540 (BMS-986353), CD19-CAR T Cells, in Participants with Active SLE Despite Immunosuppressants (Breakfree-SLE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Celgene Corp.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

22 Oct 2025 → ongoing

Decision date (initial)

2025-10-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Celgene Corporation

External identifiers

EU CT number

2024-519278-37-00

WHO UTN

U1111-1315-1600

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Pharmacoeconomic, Pharmacodynamic, Safety

To evaluate the efficacy of CC-97540 in participants with SLE

Secondary objectives 6

1. To evaluate additional efficacy parameters in participants with SLE
2. To evaluate duration of and time to response in patients with SLE
3. To assess use of glucocorticoids for the treatment of SLE
4. Evaluation of effects of CC-97540 on SLE relevant autoantibodies and complement factors
5. To assess key PROs (SLE symptoms, functioning, and overall HRQoL)
6. To assess the safety of CC-97540 in participants with SLE

Conditions and MedDRA coding

Lupus Nephritis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymised participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Be at least 16 years old and must have a body weight of ≥ 40 kg
2. Have Systemic Lupus Erythematosus (SLE), as defined by the EULAR/ACR 2019 criteria
3. Have tried glucocorticoids and at least two different immune-suppressing drugs for SLE, for at least three months each, but these treatments didn't work well enough
4. Have active SLE determined by a scoring system called BILAG (a tool to measure SLE disease activity), and by testing for certain proteins in the blood that are signs of SLE
5. Have a specific type of kidney disease related to SLE (lupus nephritis [LN]), they must have had a kidney biopsy within the last six months.

Exclusion criteria 9

1. Other diseases or conditions, or be receiving treatments, that might make it hard to tell if the study drug, CC-97540, is working
2. Uncontrolled infections
3. Serious heart conditions
4. Unresolved problems with their central nervous system
5. Cancer or a disease where the body makes too many lymphocytes, unless they have been free of the disease for at least two years
6. Women who are pregnant, nursing, or planning to become pregnant
7. Having had certain types of cell therapies or a stem cell transplant
8. Having received a live vaccine within six weeks before starting the study drug
9. Poor organ function, as determined by lab tests at the study site

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 18

1. Complete renal response (CRR) for participants with baseline lupus nephritis (LN)
2. Participants with drug-free DORIS remission
3. CRR for participants with baseline LN
4. Modified CRR for participants with baseline LN
5. Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6
6. Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6
7. Number and Severity of participants with flares as assessed by SLEDAI flare index
8. Change from baseline in proteinuria and estimated glomerular filtration rate (eGFR)
9. Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC) damage
10. Number and frequency of participants achieving maintenance of drug-free DORIS remission, LLDAS, and SRI-4.
11. Time from first response to loss of response for drug-free DORIS remission, Time from first response to loss of response for LLDAS, and Time from first response to loss of response for SRI-4
12. Time from baseline to first drug-free DORIS remission, LLDAS, and SRI-4
13. Duration of drug-free status
14. Percentage of participants achieving DORIS remission regardless of drug-free status
15. Cumulative glucocorticoid dose post-infusion used for SLE treatment
16. Change of serum autoantibodies and complement factors from baseline
17. Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue, SF 36 v2 Acute, EQ-5D-5L, Patient Global Impression of Severity (PGI-S) Pain, and PGI-S Fatigue
18. Patient Global Impression of Change (PGI-C) Pain and PGI-C Fatigue

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene Corp.

Sponsor organisation

Celgene Corp.

Address

Route 206 And Province Line Road

City

Princeton

Postcode

08543-4000

Country

United States

Scientific contact point

Organisation

Celgene Corp.

Contact name

GSM-CT

Public contact point

Organisation

Celgene Corp.

Contact name

GSM-CT

Third parties 15

Locations

9 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 9 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 116 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications