Diffuse Large B Cell Lymphoma，DLBCLPhase 1NCT05526313

Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory B Cell-related Tumor-predominant

A Phase 1 study testing Purinostat Mesylate 1.2mg/m^2, Purinostat Mesylate 2.4mg/m^2 and Purinostat Mesylate 4.0mg/m^2 in people with Diffuse Large B Cell Lymphoma，DLBCL, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diffuse Large B Cell Lymphoma，DLBCL
What is being tested?: Purinostat Mesylate 1.2mg/m^2, Purinostat Mesylate 2.4mg/m^2 and Purinostat Mesylate 4.0mg/m^2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteChina
Study dates: 10 Aug 2020to 29 Mar 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age 18 to 70 years old, gender is not limited;
2. Hematological tumors, including but not limited to B-cell lymphoma, multiple myeloma, B Cell acute leukemia, T-cell lymphoma, T-cell acute leukemia, and patients with disease progression, relapse, or ineligibility for standard regimen therapy after standard regimen therapy ;
3. Patients without serious organic lesions in the heart, lung, liver and kidney (LVEF (left ventricular ejection fraction >=50%; total bilirubin <=1.5×ULN; alanine aminotransferase (ALT) <=1.5×ULN; aspartate aminotransferase); (AST) <=1.5×ULN (; serum creatinine<=1.5×ULN or CCr>40mL/min);
4. Those without severe coagulation dysfunction (PT<=1.5×ULN, APTT<=1.5×ULN, TT<=1.5×ULN and FIB>=1.0 g/L);
5. Patients without severe hematopoietic dysfunction (absolute neutrophil value>=1.5×109/L, platelets >=75×109/L, hemoglobin>=80g/L), and no platelet, red blood cell, hemoglobin;
6. Patients received at least 4 weeks or more than 5 half-lives after the last antitumor treatment (chemotherapy, radiotherapy, biological therapy or immunotherapy) before enrollment;

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7. Expected survival time>= 12 weeks;
8. ECOG score <=2 points;
9. Those who agree to participate in this study and sign the informed consent form.

Who cannot join

1. The toxicity of previous anticancer therapy has not recovered to grade I or below, or has not fully recovered from previous surgery;
2. Those with severe heart, lung, liver, kidney, digestive system diseases and chronic diseases of vital organs
3. Pregnant or breastfeeding female patients, fertile female/male patients who refuse to use contraceptive measures during the trial;
4. A history of acute myocardial infarction, congestive heart failure, unstable angina pectoris, or stroke within 6 months before enrollment;
5. Patients with impaired cardiac function (ejection fraction <45% detected by echocardiography or complete left bundle branch block with ECG ST segment downshift >1 mm or T wave inversion in two or more channels; congenital ventricular or Atrial arrhythmia, clinically significant tachycardia (>100 beats/min), bradycardia (<50 beats/min), ECG QTc >450 ms (men), QTc >480 ms (women), or clinically significant cardiac Diseases (such as unstable angina, congestive heart failure, myocardial infarction within 6 months), etc.;
6. Those with central nervous system lymphoma/leukemia or mental disorders;

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7. Have a history of organ transplantation;
8. Those with severe active infection;
9. Known severe hypersensitivity to the test drug and its excipients or HDAC inhibitors;
10. HCV antigen or antibody positive, HIV antigen or antibody positive, HBsAg positive, HBcAb positive and peripheral blood HBV DNA titer detection >=1×103 IU/mL;
11. Alcohol dependence or drug abusers;
12. Those who have participated in clinical trials of other drugs within the past 1 month;
13. The researchers conclud that there are other factors that are not suitable for participating in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital Sichuan University
Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: Single-center, Dose-escalation Phase I Tolerability, Safety, Pharmacokinetics and Efficacy of Purinostat Mesylate (PM) for Injection in the Treatment of Relapsed or Refractory B Cell-related Tumor-predominant Hematologic Tumors Clinical Trials for Pharmacodynamic Evaluation

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 0.81, 1.4, 1.7, 3.8, 11.5, 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.

Conditions: Diffuse Large B Cell Lymphoma，DLBCL
Being tested: Purinostat Mesylate 1.2mg/m^2, Purinostat Mesylate 2.4mg/m^2, Purinostat Mesylate 4.0mg/m^2, Purinostat Mesylate 6.0mg/m^2, Purinostat Mesylate 8.4mg/m^2
Medical subject headings: Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Purinostat Mesylate 1.2mg/m^2Drug
1 case,The starting dose,Take the medicine once on D1, D8, D11, D15.
Purinostat Mesylate 2.4mg/m^2Drug
Take the medicine once on D1, D8, D11, D15.
Purinostat Mesylate 4.0mg/m^2Drug
Take the medicine once on D1, D8, D11, D15.
Purinostat Mesylate 6.0mg/m^2Drug
Take the medicine once on D1, D8, D11, D15.
Purinostat Mesylate 8.4mg/m^2Drug
Take the medicine once on D1, D8, D11, D15.
Purinostat Mesylate 11.2mg/m^2Drug
Take the medicine once on D1, D8, D11, D15.
Purinostat Mesylate 15mg/m^2Drug
Take the medicine once on D1, D8, D11, D15.

Study groups in NCT05526313
Study group	Role	What they receive
1.2mg/m^2	Experimental	Not described Receives: Drug: Purinostat Mesylate 1.2mg/m^2
2.4mg/m^2	Experimental	Not described Receives: Drug: Purinostat Mesylate 2.4mg/m^2
4.0mg/m^2	Experimental	Not described Receives: Drug: Purinostat Mesylate 4.0mg/m^2
6.0mg/m^2	Experimental	Not described Receives: Drug: Purinostat Mesylate 6.0mg/m^2
8.4mg/m^2	Experimental	Not described Receives: Drug: Purinostat Mesylate 8.4mg/m^2
11.2mg/m^2	Experimental	Not described Receives: Drug: Purinostat Mesylate 11.2mg/m^2
15mg/m^2	Experimental	Not described Receives: Drug: Purinostat Mesylate 15mg/m^2

What is being measured

The primary outcome is the main question the study is designed to answer.

Purinostat Mesylate Pharmacokinetics (PK)：Cmax
Estimation of maximum observed plasma concentration
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：Tmax
Estimation of time to reach Cmax
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：AUC0-72h
Estimation of AUC from time zero to the last measured time point
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：AUC0-∞
Estimation of AUC from time zero extrapolated to infinity
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：MRT
Estimation of mean residence time
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：Vd
Estimation of apparent volume of distribution
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：t1/2
Estimation of terminal elimination half-life
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：CLz/F
Estimation of clearance when dosed orally
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：Vz/F
Estimation of apparent volume of distribution when dosed orally
Measured: 72hours
Purinostat Mesylate Pharmacokinetics (PK)：Ke
Estimation of the elimination rate constant of a drug in the body
Measured: 72hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202029 Mar 2024

First posted2 Sep 2022
Study start10 Aug 2020
Primary completion7 Sep 2022
Study completion29 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diffuse Large B Cell Lymphoma，DLBCLStudies of the same condition, open and under way.
More trials run by Chengdu Zenitar Biomedical Technology Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05526313
Sponsor's protocol ID: GZ2018-001-1.0
Status last verified: Sep 2025
First submitted: 31 Aug 2022
Last updated: 1 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yang L, Qiu Q, Wang J, Wen Y, Li H, Liang R, Feng Y, Wang F, Lin X, Tang M, Yang J, Pei H, Zhao P, Wang J, Xiang J, Miao J, Zheng L, Tan K, Wang Y, Hu Y, Chen L, Zhao W, Niu T. Preclinical and first-in-human of purinostat mesylate, a novel selective HDAC I/IIb inhibitor, in relapsed/refractory multiple myeloma and lymphoma. Signal Transduct Target Ther. 2025 Jun 23;10(1):201. doi: 10.1038/s41392-025-02285-w.
PubMed 40562746

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-center, Dose-escalation Phase I Tolerability, Safety, Pharmacokinetics and Efficacy of Purinostat Mesylate (PM) for Injection in the Treatment of Relapsed or Refractory B Cell-related Tumor-predominant Hematologic Tumors Clinical Trials for Pharmacodynamic Evaluation
ClinicalTrials.gov ID: NCT05526313
Acronym / sponsor ID: GZ2018-001-1.0
Conditions: Diffuse Large B Cell Lymphoma，DLBCL
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
Study start: 10 Aug 2020 (actual)
Primary completion: 7 Sep 2022 (actual)
Study completion: 29 Mar 2024 (actual)
First posted: 2 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Secondary Purpose:

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
1.2mg/m^2	Experimental	Drug: Purinostat Mesylate 1.2mg/m^2
2.4mg/m^2	Experimental	Drug: Purinostat Mesylate 2.4mg/m^2
4.0mg/m^2	Experimental	Drug: Purinostat Mesylate 4.0mg/m^2
6.0mg/m^2	Experimental	Drug: Purinostat Mesylate 6.0mg/m^2
8.4mg/m^2	Experimental	Drug: Purinostat Mesylate 8.4mg/m^2
11.2mg/m^2	Experimental	Drug: Purinostat Mesylate 11.2mg/m^2
15mg/m^2	Experimental	Drug: Purinostat Mesylate 15mg/m^2

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

1. Age 18 to 70 years old, gender is not limited;
2. Hematological tumors, including but not limited to B-cell lymphoma, multiple myeloma, B Cell acute leukemia, T-cell lymphoma, T-cell acute leukemia, and patients with disease progression, relapse, or ineligibility for standard regimen therapy after standard regimen therapy ;
3. Patients without serious organic lesions in the heart, lung, liver and kidney (LVEF (left ventricular ejection fraction >=50%; total bilirubin <=1.5×ULN; alanine aminotransferase (ALT) <=1.5×ULN; aspartate aminotransferase); (AST) <=1.5×ULN (; serum creatinine<=1.5×ULN or CCr>40mL/min);
4. Those without severe coagulation dysfunction (PT<=1.5×ULN, APTT<=1.5×ULN, TT<=1.5×ULN and FIB>=1.0 g/L);
5. Patients without severe hematopoietic dysfunction (absolute neutrophil value>=1.5×109/L, platelets >=75×109/L, hemoglobin>=80g/L), and no platelet, red blood cell, hemoglobin;

Key exclusion criteria (13 listed)

1. The toxicity of previous anticancer therapy has not recovered to grade I or below, or has not fully recovered from previous surgery;
2. Those with severe heart, lung, liver, kidney, digestive system diseases and chronic diseases of vital organs
3. Pregnant or breastfeeding female patients, fertile female/male patients who refuse to use contraceptive measures during the trial;
4. A history of acute myocardial infarction, congestive heart failure, unstable angina pectoris, or stroke within 6 months before enrollment;
5. Patients with impaired cardiac function (ejection fraction <45% detected by echocardiography or complete left bundle branch block with ECG ST segment downshift >1 mm or T wave inversion in two or more channels; congenital ventricular or Atrial arrhythmia, clinically significant tachycardia (>100 beats/min), bradycardia (<50 beats/min), ECG QTc >450 ms (men), QTc >480 ms (women), or clinically significant cardiac Diseases (such as unstable angina, congestive heart failure, myocardial infarction within 6 months), etc.;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Purinostat Mesylate 1.2mg/m^21 case,The starting dose,Take the medicine once on D1, D8, D11, D15.	Drug	1.2mg/m^2
Purinostat Mesylate 2.4mg/m^2Take the medicine once on D1, D8, D11, D15.	Drug	2.4mg/m^2
Purinostat Mesylate 4.0mg/m^2Take the medicine once on D1, D8, D11, D15.	Drug	4.0mg/m^2
Purinostat Mesylate 6.0mg/m^2Take the medicine once on D1, D8, D11, D15.	Drug	6.0mg/m^2
Purinostat Mesylate 8.4mg/m^2Take the medicine once on D1, D8, D11, D15.	Drug	8.4mg/m^2
Purinostat Mesylate 11.2mg/m^2Take the medicine once on D1, D8, D11, D15.	Drug	11.2mg/m^2
Purinostat Mesylate 15mg/m^2Take the medicine once on D1, D8, D11, D15.	Drug	15mg/m^2

Primary outcome

Purinostat Mesylate Pharmacokinetics (PK)：Cmax
Time frame: 72hours
Estimation of maximum observed plasma concentration
Purinostat Mesylate Pharmacokinetics (PK)：Tmax
Time frame: 72hours
Estimation of time to reach Cmax
Purinostat Mesylate Pharmacokinetics (PK)：AUC0-72h
Time frame: 72hours
Estimation of AUC from time zero to the last measured time point
Purinostat Mesylate Pharmacokinetics (PK)：AUC0-∞
Time frame: 72hours
Estimation of AUC from time zero extrapolated to infinity
Purinostat Mesylate Pharmacokinetics (PK)：MRT
Time frame: 72hours
Estimation of mean residence time
Purinostat Mesylate Pharmacokinetics (PK)：Vd
Time frame: 72hours
Estimation of apparent volume of distribution
Purinostat Mesylate Pharmacokinetics (PK)：t1/2
Time frame: 72hours
Estimation of terminal elimination half-life
Purinostat Mesylate Pharmacokinetics (PK)：CLz/F
Time frame: 72hours
Estimation of clearance when dosed orally
Purinostat Mesylate Pharmacokinetics (PK)：Vz/F
Time frame: 72hours
Estimation of apparent volume of distribution when dosed orally
Purinostat Mesylate Pharmacokinetics (PK)：Ke
Time frame: 72hours
Estimation of the elimination rate constant of a drug in the body

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
Derived from this study: PubMed 40562746Yang L, Qiu Q, Wang J, Wen Y, Li H, Liang R, Feng Y, Wang F, Lin X, Tang M, Yang J, Pei H, Zhao P, Wang J, Xiang J, Miao J, Zheng L, Tan K, Wang Y, Hu Y, Chen L, Zhao W, Niu T. Preclinical and first-in-human of purinostat mesylate, a novel selective HDAC I/IIb inhibitor, in relapsed/refractory multiple myeloma and lymphoma. Signal Transduct Target Ther. 2025 Jun 23;10(1):201. doi: 10.1038/s41392-025-02285-w.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ting Niu, Doctor principal investigator

West China Hospital

Yongsheng Wang, Doctor principal investigator

West China Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Purinostat Mesylate Pharmacokinetics (PK)：Cmax (time frame: 72hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05526313, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.