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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Key

inclusion criteria:

1. 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. 2. Positive test for ANCA-autoantibodies. 3. GPA and MPA participants with severe active disease.Key

exclusion criteria:

1. 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. 2. Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol. 3. Other systemic autoimmune diseases requiring therapy. 4. 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. 5. Inadequate organ function

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06868290
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Israel, Japan, Singapore, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	ANCA Associated Vasculitis (AAV)

Additional Details

This is a Phase 2, randomized, assessor-blinded active controlled study. This study comprises two cohorts:

- A lead-in cohort enrolling participants to receive rapcabtagene autoleucel.

- A randomized cohort with participants receiving either rapcabtagene autoleucel or comparator.

After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.

Arms & Interventions

Arms

Experimental: Rapcabtagene autoleucel

Single infusion of rapcabtagene autoleucel (YTB323) and concomitant glucocorticoids as per protocol

Active Comparator: Active comparator

Comparator and concomitant glucocorticoids as per protocol

Interventions

Biological: - Rapcabtagene autoleucel

Single infusion of rapcabtagene autoleucel

Other: - Active Comparator

Active comparator option as per protocol

Drug: - Glucocorticoids

Concomitant glucocorticoids as per protocol

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Oregon Health Sciences University, Portland, Oregon

Status

Recruiting

Address

Oregon Health Sciences University

Portland, Oregon, 97239

Site Contact

Yuki Harry

[email protected]

1-888-669-6682