Completed

A Phase I/II Study Evaluating ZX-101A in Patients with Relapsed/Refractory Hematological Malignancies

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What is being tested

ZX-101A

Drug
Who is being recruted

Hemic and Lymphatic Diseases+8

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+36 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorNanjing Zenshine Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 17, 2022

Actual date on which the first participant was enrolled.

Phase I includes two parts: dose escalation and dose expansion. It's mainly to explore the safety and tolerability of ZX-101A in patients with relapsed/ refractory hematological malignancies \[Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), indolent NHL, and other NHL subtypes\], and to determine RP2D. * Part 1. ZX-101A dose escalation * Part 2. ZX-101A dose expansion in two specific types of lymphoma, i.e. PTCL /CTCL or one B-iNHL.

Official TitleA Phase I/II Study Evaluating ZX-101A in Patients with Relapsed/Refractory Hematological Malignancies
NCT05269940
Principal SponsorNanjing Zenshine Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, T-CellLymphoma, T-Cell, Peripheral

Criteria

13 inclusion criteria required to participate
Males and females who are ≥ 18 years old
Minimum life expectancy ≥ 3 months (determined by investigator assessment)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to1.
Histopathological and cytological confirmed diagnosis of hematological malignancies.
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23 exclusion criteria prevent from participating
Previous use of PI3K δ/γ dual inhibitors
Received approved anti-cancer drugs within 28 days (42 days for nitrosoureas) or 5 half-lives, whichever is longer.
Radiation treatment within 2 weeks prior to first dose of study treatment.
Received investigational study drug within 28 days (or 5 half-lives, whichever is longer).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
ZX-101A administered orally at level A once daily

Group II

Experimental
ZX-101A administered orally at level B once daily

Group III

Experimental
ZX-101A administered orally at level C once daily

Group IV

Experimental
ZX-101A administered orally at level D once daily

Group 5

Experimental
ZX-101A administered orally at level E once daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Anhui Medical University No.4 Affiliated Hospital

Hefei, ChinaOpen Anhui Medical University No.4 Affiliated Hospital in Google Maps
Suspended

Wuhan Union Hospital

Wuhan, China
Suspended

Hunan Tumor Hospital

Changsha, China
Completed3 Study Centers