Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519526
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With RelapsedRefractory Peripheral T Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With RelapsedRefractory Peripheral T Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-08
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 is an open-label prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with RR PTCL The study plans to enroll approximately 25 patients 6-12 patients will receive SHR-0302 monotherapy and SHR-0302SHR-2554 combination therapy in the safety run-in phase According to the safety observed the investigators discuss and decide to select a dose group to explore the efficacy and safety 13 patients may be enrolled in the expansion phase
Detailed Description:
This is an open-label prospective exploratory clinical study The plan is to enroll 12-25 patients with relapsedrefractory peripheral T-cell lymphoma rr PTCL to receive a combination of SHR-0302 and SHR-2554 The primary objectives are to evaluate the efficacy and safety of the SHR-0302 and SHR-2554 combination in the treatment of rr PTCL Subjects will receive the investigating drugs combination SHR-0302 and SHR-2554 until study completion unacceptable toxicity disease progression withdrawal of informed consent or investigators discontinue treatment
The study is divided into two parts Part I is a safety run-in phase and part II is an efficacy exploration phase
Part I
Cohort 1 Explore the recommended dose and safety of SHR-0302 monotherapy Cohort 2 Based on the efficacy and safety observed in Cohort 1 explore the clinically recommended dose and safety of the SHR-0302 and SHR-2554
Part II Based on the safety and tolerability observed during part I the investigators will discuss and select one tolerable dose cohort to explore the efficacy and safety
The study is divided into two parts Part I is a safety run-in phase and part II is an efficacy exploration phase
Part I
Cohort 1 Explore the recommended dose and safety of SHR-0302 monotherapy Cohort 2 Based on the efficacy and safety observed in Cohort 1 explore the clinically recommended dose and safety of the SHR-0302 and SHR-2554
Part II Based on the safety and tolerability observed during part I the investigators will discuss and select one tolerable dose cohort to explore the efficacy and safety
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