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Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA

ConditionANCA Associated Vasculitis (AAV)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 (ACR/EULAR 2022) classification criteria

Positive test for ANCA-autoantibodies

GPA and MPA participants with severe active disease

Disqualifiers

Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study

Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol

Other systemic autoimmune diseases requiring therapy

Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rapcabtagene autoleucel

    Biological/Vaccine

    Single infusion of rapcabtagene autoleucel

  • Active Comparator

    Other intervention

    Active comparator option as per protocol

  • Glucocorticoids

    Drug

    Concomitant glucocorticoids as per protocol

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Rapcabtagene autoleucelExperimental treatment 2 interventions
Group B: Active comparatorActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Event-free survival (EFS)

Event-free survival (EFS) defined as the time from Randomization to the first occurrence of as per protocol defined events.

Time frame
From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization

Secondary outcomes

1

Percentage of patients achieving complete remission

Complete remission is defined by Birmingham Vasculitis Activity Score version 3 (BVASv3)

Time frame
Up to Week 13
2

Adjusted annual cumulative GC dose between Randomization and analysis cutoff date

The adjusted annual cumulative glucocorticoid dose refers to the total amount of glucocorticoids administered to a patient over the course of a year, adjusted for any changes in dosage, and measured up to the defined week of treatment as per protocol.

Time frame
From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
3

ANCA seronegativity and sustaining ANCA seronegativity until the analysis cutoff date

ANCA seronegativity means that the patient tests negative for ANCA antibodies.

Time frame
From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
4

Change from baseline in estimated glomerular filtration rate (eGFR) at Week 39

Change from baseline in estimated glomerular filtration rate (eGFR) at Week 39.

Time frame
Up to Week 39

Other outcomes

Sponsors and contacts

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

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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