Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293716
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-18
Brief Title:
CVL237 Tablets for APDSPASLI
Sponsor:
Convalife Shanghai Co Ltd
Organization:
Convalife Shanghai Co Ltd
Study Overview
Official Title:
An Open Dose-exploration Study Followed by a Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of CVL237 Tablets in Patients With APDSPASLI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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 was designed to evaluate the efficacy and safety of CVL237 tablets in patients with APDSPASLI activated phosphoinositol 3-kinase δ syndrome p110 delta-activated mutation leading to senescent T cells lymphadenopathy and immune deficiency
Detailed Description:
The study was divided into two parts
Part I is an open dose-escalation study planned to enroll five patients with APDSPASLI to determine the safety tolerability pharmacokinetics PK and in vivo pharmacodynamics PD pAkt of CVL237 tablets at two different dose levels Patients were given CVL237 tablets 100 mg day QD for 4 weeks 28 days and safety assessment was performed on day 28 of the first cycle If there was no safety risk patients could take CVL237 tablets 200 mg day QD for 4 weeks 28 days
Part II is a randomized double-blind placebo-controlled study of approximately 30 patients with APDSPASLI On day 1 patients were randomly assigned to the trial and placebo groups in a 21 ratio to take an oral CVL237 tablet or a placebo CVL237 simulant once daily Efficacy and safety were evaluated on days 29 57 and 85 The efficacy of CVL237 tablets in reducing lymphadyopathy will be investigated as measured by changes in the sum of diameter products SPD of target lesions selected from MRI or CT imaging according to the Lugano 2014 method as well as changes in the percentage of naive B cells to total B cells relative to baseline The CVL237 tablets will also be evaluated for safety PK
Part I is an open dose-escalation study planned to enroll five patients with APDSPASLI to determine the safety tolerability pharmacokinetics PK and in vivo pharmacodynamics PD pAkt of CVL237 tablets at two different dose levels Patients were given CVL237 tablets 100 mg day QD for 4 weeks 28 days and safety assessment was performed on day 28 of the first cycle If there was no safety risk patients could take CVL237 tablets 200 mg day QD for 4 weeks 28 days
Part II is a randomized double-blind placebo-controlled study of approximately 30 patients with APDSPASLI On day 1 patients were randomly assigned to the trial and placebo groups in a 21 ratio to take an oral CVL237 tablet or a placebo CVL237 simulant once daily Efficacy and safety were evaluated on days 29 57 and 85 The efficacy of CVL237 tablets in reducing lymphadyopathy will be investigated as measured by changes in the sum of diameter products SPD of target lesions selected from MRI or CT imaging according to the Lugano 2014 method as well as changes in the percentage of naive B cells to total B cells relative to baseline The CVL237 tablets will also be evaluated for safety PK
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?:
False
Is an FDA AA801 Violation?:
None