Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05526313
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2022-08-31
Brief Title:
Study of Prilinostat Mesylate for Injection in the Treatment of Relapsed or Refractory B Cell-related Tumor-predominant
Sponsor:
Chengdu Zenitar Biomedical Technology Co Ltd
Organization:
Chengdu Zenitar Biomedical Technology Co Ltd
Study Overview
Official Title:
Single-center Dose-escalation Phase I Tolerability Safety Pharmacokinetics and Efficacy of Prilinostat Mesylate PM for Injection in the Treatment of Relapsed or Refractory B Cell-related Tumor-predominant Hematologic Tumors Clinical Trials for Pharmacodynamic Evaluation
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Purinostat mesylate for injection PM was the novel and highly potent Class I a and IIb HDAC-selective inhibitors The results of regular blood sampling analysis of the mouse B-cell lymphoma model induced by ighmyc transgenic mice showed that the treatment of PM in each group reduced the proportion of peripheral blood tumor cells in mice Therefore PM has the potential to treat diffuse large B cell lymphoma
The results of in vitro enzymatic activity screening showed that PM has high inhibitory activity on HDAC tumors including HDAC1 2 3 8 subtypes and type II HDACs including HDAC6 10 isoforms which are closely related to tumors in the HDAC family Therefore the results of in vitro enzyme activity screening showed that the IC50 values of PM for inhibiting HDAC1 HDAC2 HDAC3 HDAC8 HDAC6 and HDAC10 subtypes of HDAC class I and HDAC class IIb were 081 14 17 38 115 and 11 nM respectively However the inhibitory activity of HDAC IIa and HDAC IV enzymes was low and its IC50 values for HDAC4 HDAC5 HDAC7 HDAC9 and HDAC11 subtypes of HDAC IIa and HDAC IV were 1072 426 590 622 and 3349 nM respectively These data means PM exist high selectivity for tumor-associated HDAC class I and HDAC IIb
Compared with the blank control group the body weight of the tumor-bearing animals in each dose of PM group did not decrease seriously during the treatment process and the animals were in good condition during the whole experiment indicating that the PM is efficacy and safe
During the course of the experiment the tumor cell population GFP B220 in the blood of the animals basically regressed after treatment with Prilistat hydrochloride
Research purposes
Main purpose
Observation of patients with relapsed or refractory hematological tumors including but not limited to after standard therapy mainly in patients with relapsed or refractory B cell-related tumors Tolerability and safety of B-cell lymphoma multiple myeloma B-cell acute leukemia T-cell lymphoma T-cell acute leukemia with disease progression or ineligible for standard therapy
To observe the dose-limiting toxicity DLT in patients with relapsed or refractory B cell-related tumors and hematological tumors and determine its maximum tolerated dose MTD which is the maximum tolerated dose MTD Phase II clinical dosing schedule provides the basis
Secondary Purpose
To evaluate the pharmacokinetic parameters of patients with relapsed or refractory B-cell-related tumors and hematological tumors after single and multiple intravenous infusions of priinostat mesylate for injection
To evaluate the pharmacodynamics of patients with relapsed or refractory B cell-related tumors and hematological tumors after single and multiple intravenous infusions of priinostat mesylate for injection
To preliminarily observe the efficacy of Priinostat mesylate for injection in the treatment of patients with relapsed or refractory hematological tumors mainly patients with B cell-related tumors
The results of in vitro enzymatic activity screening showed that PM has high inhibitory activity on HDAC tumors including HDAC1 2 3 8 subtypes and type II HDACs including HDAC6 10 isoforms which are closely related to tumors in the HDAC family Therefore the results of in vitro enzyme activity screening showed that the IC50 values of PM for inhibiting HDAC1 HDAC2 HDAC3 HDAC8 HDAC6 and HDAC10 subtypes of HDAC class I and HDAC class IIb were 081 14 17 38 115 and 11 nM respectively However the inhibitory activity of HDAC IIa and HDAC IV enzymes was low and its IC50 values for HDAC4 HDAC5 HDAC7 HDAC9 and HDAC11 subtypes of HDAC IIa and HDAC IV were 1072 426 590 622 and 3349 nM respectively These data means PM exist high selectivity for tumor-associated HDAC class I and HDAC IIb
Compared with the blank control group the body weight of the tumor-bearing animals in each dose of PM group did not decrease seriously during the treatment process and the animals were in good condition during the whole experiment indicating that the PM is efficacy and safe
During the course of the experiment the tumor cell population GFP B220 in the blood of the animals basically regressed after treatment with Prilistat hydrochloride
Research purposes
Main purpose
Observation of patients with relapsed or refractory hematological tumors including but not limited to after standard therapy mainly in patients with relapsed or refractory B cell-related tumors Tolerability and safety of B-cell lymphoma multiple myeloma B-cell acute leukemia T-cell lymphoma T-cell acute leukemia with disease progression or ineligible for standard therapy
To observe the dose-limiting toxicity DLT in patients with relapsed or refractory B cell-related tumors and hematological tumors and determine its maximum tolerated dose MTD which is the maximum tolerated dose MTD Phase II clinical dosing schedule provides the basis
Secondary Purpose
To evaluate the pharmacokinetic parameters of patients with relapsed or refractory B-cell-related tumors and hematological tumors after single and multiple intravenous infusions of priinostat mesylate for injection
To evaluate the pharmacodynamics of patients with relapsed or refractory B cell-related tumors and hematological tumors after single and multiple intravenous infusions of priinostat mesylate for injection
To preliminarily observe the efficacy of Priinostat mesylate for injection in the treatment of patients with relapsed or refractory hematological tumors mainly patients with B cell-related tumors
Detailed Description:
None
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