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A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

ConditionSystemic Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening.

Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment

Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening.

Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986353

    Drug

    Specified dose on specified days

  • Fludarabine

    Drug

    Specified dose on specified days

  • Cyclophosphamide

    Drug

    Specified dose on specified days

  • Tocilizumab

    Drug

    Specified dose on specified days

  • Rituximab

    Drug

    Specified dose on specified days

  • Nintedanib

    Drug

    Specified dose on specified days

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Arm A: BMS-986353Experimental treatment 3 interventions
Group B: Arm B: Standard of CareExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

The absolute change from baseline in Forced Vital Capacity (FVC) in mL

Time frame
At 12 months

Secondary outcomes

1

The absolute change from baseline in Modified Rodnan Skin Score (mRSS)

Time frame
At month 12
2

The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score

Time frame
Up to month 36
3

Time to progression, defined as the time from randomization to progressive disease

Time frame
Approximately 54 months
4

The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue

Time frame
Up to month 36

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Lead sponsor

Celgene Corporation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: