Health TrialsbyHealthPanel

A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

ConditionRefractory Autoimmune Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

SLE population:.

IIM population:.

SSc population:.

RA population:.

Trial design

Design model

Single group

Treatments tested in this trial

  • BMS-986515

    Genetic

    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

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: BMS-986515 AdministrationExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Number of participants with treatment-emergent adverse events (TEAEs)

All participants

Time frame
Up to 24 months post BMS-986515 infusion
2

Number of participants with serious AEs (SAEs)

All participants

Time frame
Up to 24 months post BMS-986515 infusion
3

Number of participants with AEs of special interest (AESIs)

All participants

Time frame
Up to 24 months post BMS-986515 infusion
4

Number of participants with laboratory abnormalities

All participants

Time frame
Up to 24 months post BMS-986515 infusion

Secondary outcomes

1

Maximum observed concentration (Cmax)

All participants

Time frame
Up to 2 years
2

Area under the concentration-time curve (AUC)

All participants

Time frame
Up to 2 years
3

Time of maximum observed concentration (Tmax)

All participants

Time frame
Up to 2 years
4

Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24

All participants

Time frame
Up to 2 years

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

Source ClinicalTrials.gov
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