Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
Study NCT ID:
NCT03983668
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2019-06-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CMP-001 for Relapsed and Refractory Lymphoma
Sponsor:
Umar Farooq
Organization:
Study Overview
Official Title:
Phase I/II Study of Pembrolizumab and In-situ Injection of CMP-001 in Patients With Relapsed and Refractory Lymphomas
Status:
COMPLETED
Status Verified Date:
2025-04
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:
This study is a single-arm, open-label, phase I/II trial designed to find a CMP-001 dose that, in combination with pembrolizumab, has optimal clinical efficacy and acceptable toxicity for patients with relapsed and refractory lymphomas.
Detailed Description:
This is a single center, open-label, combined Phase I/II clinical study of intratumoral administration of CMP-001 and intravenous administration of pembrolizumab in selected participants with lymphoma. The key study objective is to find a CMP-001 dose that in combination with pembrolizumab has optimal clinical efficacy and acceptable toxicity. Dose-finding will be performed with an adaptive clinical trial design. Secondary study objectives include characterization of safety, pharmacodynamics, and assessment of anti-lymphoma activity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: