Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590545
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Anti-CD 19 CAR-T Cell Therapy in Patients with ANCA Vasculitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anti-CD 19 CAR-T Cell Therapy in Patients with ANCA Vasculitis a Two-stage Interventional Prospective Open-label Phase III Trial in Patients with Active Treatment Refractory ANCA-IgG-positive Vasculitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAL
Brief Summary:
The goal of this phase III clinical trial is to investigate anti-CD 19 chimeric antigen receptor T cell CAR-T cell therapy in patients with antineutrophil cytoplasmic antibodies ANCA immunoglobulin IgG positive ANCA associated vasculitis AAV
The main questions it aims to answer are
To assess the safety of anti-CD19 CAR-T cell therapy in subjects with active treatment refractory ANCA-IgG-positive AAV
To assess the clinical efficacy of anti-CD19 CAR-T cell therapy in subjects with active treatment refractory ANCA-IgG-positive AAV
To assess the ANCA seroconversion rate in subjects with active treatment refractory ANCA-IgG-positive AAV
Participants will receive a single dose of KYV-101 iv an autologous fully-human anti-CD19 CAR-T cell immunotherapy Follow-up time is 52 weeks with regular visits at the site
The main questions it aims to answer are
To assess the safety of anti-CD19 CAR-T cell therapy in subjects with active treatment refractory ANCA-IgG-positive AAV
To assess the clinical efficacy of anti-CD19 CAR-T cell therapy in subjects with active treatment refractory ANCA-IgG-positive AAV
To assess the ANCA seroconversion rate in subjects with active treatment refractory ANCA-IgG-positive AAV
Participants will receive a single dose of KYV-101 iv an autologous fully-human anti-CD19 CAR-T cell immunotherapy Follow-up time is 52 weeks with regular visits at the site
Detailed Description:
This study aims to investigate the use of KYV101 a fully human anti-CD19 CAR T cell therapy in ANCA-IgG-positive AAV patients who are refractory to previous treatments This study is designed to determine i the safety of this B-cell targeted therapy ii the clinical efficacy iii the impact on the immunological status of the patient and in particular on ANCA positivity and iv the ability to induce long-term deep clinical and molecular remission and drug-free survival
The investigational product IMP KYV-101 is an autologous fully-human anti-CD19 CAR T-cell immunotherapy Before IMP infusion patients will receive a premedication of 4 mg Dimetindenmaleat iv or equivalent antihistamine and 1000 mg oral acetaminophene Prophylactic doses of acyclovir of 400mg 2x daily as well as cotrimoxazole 960mg 3x weekly will be administered orally following CAR T cell infusion until week 24 Tocilizumab 8mgkg will be administered intravenously when required for treatment of IMP-related cytokine release syndrome Dexamethasone as needed will be administered intravenously when required for treatment of neurological adverse event ICANS
Follow-up time is 52 weeks with regular visits at the site
The investigational product IMP KYV-101 is an autologous fully-human anti-CD19 CAR T-cell immunotherapy Before IMP infusion patients will receive a premedication of 4 mg Dimetindenmaleat iv or equivalent antihistamine and 1000 mg oral acetaminophene Prophylactic doses of acyclovir of 400mg 2x daily as well as cotrimoxazole 960mg 3x weekly will be administered orally following CAR T cell infusion until week 24 Tocilizumab 8mgkg will be administered intravenously when required for treatment of IMP-related cytokine release syndrome Dexamethasone as needed will be administered intravenously when required for treatment of neurological adverse event ICANS
Follow-up time is 52 weeks with regular visits at the site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None