NCT05563844

Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Active, enrolled Phase 2 Last updated 4 February 2026

What this trial tests

Phase 2 trial testing PM 8.4 mg/m^2 in Diffuse Large B Cell Lymphoma，DLBCL in 74 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 November 2022

Primary endpoint
30 December 2026

1 December 2027

Quick facts

Lead sponsor	Chengdu Zenitar Biomedical Technology Co., Ltd
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	8 November 2022
Primary completion	30 December 2026
Estimated completion	1 December 2027
Sites	2 locations across China

Drugs / interventions tested

• PM 8.4 mg/m^2 — full drug profile →
• PM 11.2 mg/m^2 — full drug profile →

Conditions studied

• Diffuse Large B Cell Lymphoma，DLBCL — all drugs for Diffuse Large B Cell Lymphoma，DLBCL →

Sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Diffuse Large B Cell Lymphoma，DLBCL. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purinostat mesylate for injection (PM) was the novel and highly potent Class Ia and IIb HDAC selective inhibitor. 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.

Compared with the blank control group, the body weight of the tumor-bearing animals in each dose of PM group did not decrease significantly during the treatment process, and the animals were in good condition during the whole experiment, indicating that the PM is efficacious and safe.

Main purpose:

To further explore the safe and effective dose of purinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma.

To evaluate the objective response rate (ORR) of purinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma.

Secondary purpose:

To evaluate the time to tumor response (TTR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) in the treatment of relapsed or refractory diffuse large B-cell lymphoma with purinostat mesylate for injection ), overall survival (OS).

Assessing the safety and tolerability of purinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma.

Exploratory purpose:

To explore the biomarkers related to the efficacy of purinostat mesylate for injection.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Unraveling the Epigenetic Landscape of Mature B Cell Neoplasia: Mechanisms, Biomarkers, and Therapeutic Opportunities.
   Maher N, Maiellaro F, Ghanej J, Rasi S, et al · · 2025 · cited 7× · PMID 40943058 · DOI 10.3390/ijms26178132
2. Preclinical and first-in-human of purinostat mesylate, a novel selective HDAC I/IIb inhibitor, in relapsed/refractory multiple myeloma and lymphoma.
   Yang L, Qiu Q, Wang J, Wen Y, et al · · 2025 · cited 6× · PMID 40562746 · DOI 10.1038/s41392-025-02285-w