Trial · NCT05869955
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
NCT05869955, Phase 1, Active not recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1). Trials, record NCT05869955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05869955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
- NCT number
- NCT05869955
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 270 participants, estimated
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Interventions
- CC-97540, Fludarabine, Cyclophosphamide, Tocilizumab
- First posted
- 2023-05-23
- Last updated
- 2026-08-03
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-emergent adverse events (AEs) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with serious AEs (SAEs) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with AEs of special interest (AESI) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with laboratory abnormalities in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Number of participants with Dose Limiting Toxicities (DLT) in each indication. | Up to 2 years after CC-97540 infusion | |
| Primary | Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication. | Up to 2 years after CC-97540 infusion | |
| Secondary | Proportion of participants achieving definition of remission in SLE (DORIS) remission | At week 24 | SLE Cohort |
| Secondary | Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) | At week 24 | SLE Cohort |
| Secondary | Change in proteinuria measured by urine protein creatinine ratio (UPCR) | At week 24 | SLE Cohort |
| Secondary | Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) | At week 24 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05869955
GET https://conductscience.org/api/trials/v1/NCT05869955/registered?page=2