DZD8586

DRUG8 trials

Sponsors

Dizal (Jiangsu) Pharmaceutical Co., Ltd., Dizal Pharmaceuticals

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaDiffuse Large B Cell LymphomaLymphoma, Non-Hodgkin

Phase 1

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of DZD8586 in Healthy Adult Participants

CompletedNCT05176873

Dizal (Jiangsu) Pharmaceutical Co., Ltd.Lymphoma, Non-Hodgkin

Start: 2021-12-09End: 2022-05-22Updated: 2023-09-07

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

CompletedNCT05824585

Dizal PharmaceuticalsLymphoma, Non-Hodgkin

Start: 2023-05-15End: 2025-06-30Updated: 2026-07-02

A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (TAI-SHAN1)

CompletedNCT05844956

Dizal PharmaceuticalsLymphoma, Non-Hodgkin

Start: 2022-06-01End: 2024-02-29Updated: 2025-02-21

A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)

CompletedNCT07454863

Dizal PharmaceuticalsLymphoma, Non-Hodgkin

Start: 2026-03-16End: 2026-04-06Updated: 2026-05-14

Phase 2

DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

RecruitingNCT06539182

Dizal PharmaceuticalsChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start: 2024-04-29End: 2028-03-01Target: 155Updated: 2026-06-02

DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)

CompletedNCT06539195

Dizal PharmaceuticalsDiffuse Large B Cell Lymphoma

Start: 2024-03-13End: 2026-06-10Updated: 2026-08-04

A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)

RecruitingNCT07154264

Dizal PharmaceuticalsChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start: 2025-09-22End: 2030-01-01Target: 66Updated: 2026-06-22

Phase 3

A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)

RecruitingNCT07139873

Dizal PharmaceuticalsChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start: 2025-09-08End: 2029-12-01Target: 250Updated: 2026-06-03

Related Papers

Phase 1/2 studies of DZD8586 in CLL/SLL patients after COVALENT and non-COVALENT BTK inhibitors and BTK degraders – extended follow-up report

Blood2025-11-03

Phase 2 study of DZD8586, a non-covalent BBB penetrant LYN/BTK dual inhibitor, as monotherapy in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL; TAI-SHAN9).

Journal of Clinical Oncology2025-05-281 citations

Phase 1/2 studies of DZD8586 in CLL/SLL patients after covalent or non-covalent BTK inhibitors and BTK degraders.

Journal of Clinical Oncology2025-05-28

Phase 1/2 Studies of DZD8586, a Non-Covalent BBB Penetrant LYN/BTK Dual Inhibitor, in BTK Inhibitor Resistant Chronic Lymphocytic Leukemia (CLL) and Other B-Cell Non-Hodgkin Lymphoma (B-NHL)

Blood2024-11-051 citations

First Report of Phase 1 Studies of DZD8586, a BBB Penetrant LYN/BTK Dual Inhibitor, in Patients with B-Cell Non-Hodgkin Lymphoma (B-NHL)

Blood2023-11-022 citations

TREATMENT OF B‐CELL MALIGNANCIES WITH DZD8586 THROUGH OVERCOMING BOTH BTK‐DEPENDENT AND BTK‐INDEPENDENT RESISTANCE

Hematological Oncology2023-06-01