Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 4:49 AM
Study NCT ID:
NCT04452994
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2025-06-13
First Post:
2020-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Investigational New Drug (IND) Expanded Access Program of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Participant With Multiple Myeloma
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
Individual Patient IND Expanded Access Program JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Patient J.M. With Multiple Myeloma
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this individual-patient investigational new drug (IND) single patient request (SPR) is to provide participants treatment with JNJ-68284528, an investigational product prior to its marketing authorization. Such access may be considered for participants with serious/life-threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: