A Phase II Study of Linperlisib (YY-20394) in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
NCT05274997 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2022-10-21
Summary
This is a Phase II, single-arm study to evaluate the efficacy, safety, and PK of oral linperlisib (YY-20394) monotherapy in adult patients with R/R Peripheral T/NK Cell Lymphoma. The study will be conducted at approximately 15 sites in United States.
Conditions
- Peripheral T/NK Cell Lymphoma (R/R PTCL)
Interventions
- DRUG
-
YY-20394
Linperlisib is a strong and selective small-molecule PI3K-δ (a protein involves in the survival of cells) inhibitor, which is able to interfere with the growth, migration and survival of T/NK lymphoma cells.
Sponsors & Collaborators
-
Shanghai YingLi Pharmaceutical Co. Ltd.
lead INDUSTRY
Principal Investigators
-
Ranjit Nair, MD. · MD Anderson, Houston TX 77030 Study Chair: Swaminathan P Iyer MD
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-01
- Primary Completion
- 2023-01-01
- Completion
- 2023-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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