Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626919
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
A Phase 1 dose-escalation study designed to evaluate the safety tolerability and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis GMG Anitocabtagene autoleucel anito-cel is a BCMA-directed CAR-T cell therapy
Detailed Description:
This is a Phase 1 open-label multi-center safety and dose-escalation study of anito-cel in adult subjects with GMG MGFA Grade 2 to 4a in whom immunosuppressive therapy is clinically indicated in the judgement of the treating neurologist The primary objective of this study is to assess the safety profile including any DLT and identification of a MTD if applicable to support selection of the RP2D of anito-cel when administered to subjects with GMG
The study will have the following sequential phases screening enrollment leukapheresis pretreatment with lymphodepletion LD chemotherapy treatment with anito-cel and follow-up Optional bridging therapy is allowed at investigator discretion while anito-cel is being manufactured
Following a single infusion of anito-cel both safety and efficacy data will be assessed The DLTs will be assessed in the first 28 days following anito-cel administration and safety data will be collected throughout the study
Anitocabtagene autoleucel anito-cel drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor CAR followed by a cluster of differentiation 8 CD8 hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ΞΎ that specifically recognizes B-cell maturation antigen BCMA The active substance of anitocabtagene autoleucel is CAR CD3 T cells that have undergone ex vivo T-cell activation gene transfer by replication-deficient lentiviral vector and expansion
The study will have the following sequential phases screening enrollment leukapheresis pretreatment with lymphodepletion LD chemotherapy treatment with anito-cel and follow-up Optional bridging therapy is allowed at investigator discretion while anito-cel is being manufactured
Following a single infusion of anito-cel both safety and efficacy data will be assessed The DLTs will be assessed in the first 28 days following anito-cel administration and safety data will be collected throughout the study
Anitocabtagene autoleucel anito-cel drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor CAR followed by a cluster of differentiation 8 CD8 hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ΞΎ that specifically recognizes B-cell maturation antigen BCMA The active substance of anitocabtagene autoleucel is CAR CD3 T cells that have undergone ex vivo T-cell activation gene transfer by replication-deficient lentiviral vector and expansion
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