Health Trials

Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)

ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorAutolus Limited

About this trial

The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative

Ability and willingness to adhere to protocol's Schedule of Activities and other requirements

Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.

Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding

Disqualifiers

Prior treatment at any time with anti-CD19 therapy

More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible

Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant

History of primary antiphospholipid antibody syndrome

Trial design

Design model

Single group

Treatments tested in this trial

  • Obecabtagene autoleucel

    Biological/Vaccine

    Obecabtagene autoleucel (obe-cel) given as a single infusion

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Obe-celExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants who achieve complete renal response (CRR)

CRR is a composite endpoint

Time frame
Month 6

Secondary outcomes

1

Proportion of participants achieving remission per Definition of Remission in SLE (DORIS) criteria

DORIS is a composite endpoint

Time frame
Month 6
2

Proportion of participants achieving CRR over time

CRR is a composite endpoint

Time frame
Up to Month 24
3

Time to CRR

CRR is a composite endpoint

Time frame
Up to Month 24
4

Proportion of participants with Partial Renal Response (PRR)

PRR is a composite endpoint

Time frame
Up to Month 24

Other outcomes

Sponsors and contacts

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

Autolus Limited

Lead sponsor

PPD Development, LP

Collaborator

Source ClinicalTrials.gov
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