Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644118
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma RRMM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Clinical Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma RRMM
Status:
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:
This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 Dose expansion
Detailed Description:
This study will evaluate the safety and efficacy of OL-101 a chimeric antigen receptor T cell CAR-T therapy directed against B-Cell Maturation Antigen BCMA and G Protein-Coupled Receptor Class C Group 5 Member D GPRC5D This study is a single-arm open-label early exploratory clinical trial conducted in two phases dose escalation and dose expansion in adults with multiple myeloma The trial begins with the dose-escalation phase that focus on safety and tolerability with interval assessments for potential dose escalation or de-escalation Recommended dose will be selected at the completion of the dose escalation stage in the dose expansion stage The study aims to assess safety pharmacokineticpharmacodynamic profiles and efficacy
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