Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771883
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-24
First Post:
2023-03-06
Brief Title:
A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide
Sponsor:
ImmuneOnco Biopharmaceuticals Shanghai Inc
Organization:
ImmuneOnco Biopharmaceuticals Shanghai Inc
Study Overview
Official Title:
A Phase IbIIa Clinical Study of IMM0306 fo r Injection in Combination With Lenalidomide for the Treatment of RelapsedRefractory CD20-Positive B-Cell Non-Hodgkins Lymphoma Cell Non-Hodgkins Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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 objective of this study was to evaluate the safety and efficacy of IMM0306 in combination with lenalidomide in patients with relapsedrefractory CD20-positive B-cell non-Hodgkin lymphoma
Detailed Description:
Main study purpose
To assess the safety and tolerability of IMM0306 in combination with lenalidomide to determine the maximum tolerated dose MTD if available and the recommended Phase 2 dose RP2D
Secondary study purpose
1 To assess the antitumor efficacy of IMM0306 in combination with lenalidomide
2 To assess the immunogenicity of IMM0306 in combination with lenalidomide
3 To evaluate the pharmacokinetic PK profile of IMM0306 in combination with lenalidomide
Exploratory study purpose
1 Explore the correlation between exposure to IMM0306 and efficacy and safety data permitting
2 Explore the correlation of biomarkers with safety
To assess the safety and tolerability of IMM0306 in combination with lenalidomide to determine the maximum tolerated dose MTD if available and the recommended Phase 2 dose RP2D
Secondary study purpose
1 To assess the antitumor efficacy of IMM0306 in combination with lenalidomide
2 To assess the immunogenicity of IMM0306 in combination with lenalidomide
3 To evaluate the pharmacokinetic PK profile of IMM0306 in combination with lenalidomide
Exploratory study purpose
1 Explore the correlation between exposure to IMM0306 and efficacy and safety data permitting
2 Explore the correlation of biomarkers with safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None