golidocitinib (DZD4205) / Dizal Pharma - LARVOL DELTA

PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL (clinicaltrials.gov) - P2 | N=47 | Not yet recruiting | Sponsor: Ruijin Hospital

New P2 trial • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in First-Line Newly Diagnosed Advanced or Non-Nasal Extranodal NK/T-Cell Lymphoma (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: WEI XU

New P2 trial • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Golidocitinib Combined With Selinexor for CAEBVD (clinicaltrials.gov) - P2/3 | N=28 | Recruiting | Sponsor: Beijing Friendship Hospital

New P2/3 trial • Epstein-Barr Virus Infections • Immunology • Infectious Disease • Rare Diseases

Serum free fatty acid promotes tumor progression and predicts golidocitinib sensitivity in peripheral T-cell lymphoma. (PubMed, Blood Adv) - "In alignment with our experimental findings, relapsed or refractory PTCL patients with high serum FFA exhibited superior responses to golidocitinib treatment than those with low serum FFA. Collectively, high serum FFA is related to tumor progression and indicates golidocitinib sensitivity, providing novel insights into reprogramming lipid metabolism to dually target the tumor and microenvironment in PTCL."

Journal • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Metabolic Disorders • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK • IL10 • IL6

Golidocitinib in treating refractory or relapsed peripheral T-cell lymphoma: Primary analysis of the multinational pivotal study results (JACKPOT8). (ASCO 2023) - P2 | "Golidocitinib demonstrated its potential as a novel targeted therapy for the treatment of r/r PTCL. The updated data will be presented at the conference. Clinical trial information: NCT04105010."

Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK1

GOLIDOCITINIB IN TREATING REFRACTORY OR RELAPSED PERIPHERAL T-CELL LYMPHOMA: PRIMARY ANALYSIS OF THE MULTINATIONAL PIVOTAL STUDY RESULTS (JACKPOT8) (ICML 2023) - P2 | "Golidocitinib demonstrated its potential as a novel targeted therapy for the treatment of r/r PTCL. The updated data will be presented at the conference. Encore Abstract—previously submitted to ASCO 2023"

Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • JAK1

Prospective Single-Arm Clinical Trial of GO Regimen for HLH. (clinicaltrials.gov) - P2/3 | N=28 | Recruiting | Sponsor: Beijing Friendship Hospital

Monotherapy • New P2/3 trial • Hemophagocytic lymphohistiocytosis • Immunology • Rare Diseases

EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P1/2 trial • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma

Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=101 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21) (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Dizal Pharmaceuticals | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JACKPOT22: Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer (clinicaltrials.gov) - P2 | N=16 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Guangzhou Medical University

New P2 trial • Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27) (clinicaltrials.gov) - P2 | N=57 | Completed | Sponsor: Dizal Pharmaceuticals | Recruiting ➔ Completed | N=150 ➔ 57 | Trial completion date: Dec 2026 ➔ Oct 2025 | Trial primary completion date: May 2025 ➔ Oct 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

T-START-M1: Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma (clinicaltrials.gov) - P3 | N=136 | Not yet recruiting | Sponsor: Fudan University

New P3 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Safety and Efficacy of the JAK1 Inhibitor Combined With Intensive Immunosuppressive Therapy in Severe Aplastic Anemia (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1/2 trial • Anemia • Aplastic Anemia • Hematological Disorders

Golidocitinib Combined With GemOx in RR PTCL (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: Ruijin Hospital

New P2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Golidocitinib-based therapy in relapsed/refractory mycosis fungoides and Sézary syndrome: A real-world retrospective analysis (ASH 2025) - "Combination strategies predominated (n=9, 90%), with all combination regimens incorporating brentuximab vedotin (BV; 1.8 mg/kg IV q3wk). This pioneering real-world study demonstrates the favorable clinical efficacy and safety of Go-based regimens in pretreated MF/SS patients. Subsequent prospective trials are warranted to further explore combination strategies."

Real-world • Real-world evidence • Retrospective data • Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Dermatology • Hematological Malignancies • Infectious Disease • Lymphoma • Mycosis Fungoides • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • CD4 • IFNG

Golidocitinib, a selective JAK1 kinase inhibitor, in treatment of late thrombocytopenia after CAR-T cell therapy: Case report (ASH 2025) - P | "The patient was subsequently treated with romiplostim (250 μg, once weekly) for 2 weeks, but this did not lead to a significant improvement in platelet counts...Eltrombopag (2.5 mg orally, once daily) was administered for 2 weeks to manage thrombocytopenia...Golidocitinib, a highly selective JAK1 inhibitor, has shown promising activity in treating this adverse event. However, more clinical cases and further studies are needed to confirm this hypothesis."

CAR T-Cell Therapy • Case report • Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Follicular Lymphoma • Gene Therapies • Hematological Disorders • Hematological Malignancies • Lymphoma • Movement Disorders • Non-Hodgkin’s Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • GZMK • JAK1

A single-center retrospective study of golidocitinib for the treatment of peripheral T-cell lymphoma (ASH 2025) - "Conclusions The application of golidocitinib combination therapy in the real world can further improve outcomes for PTCL patients. In elderly unfit patients(age ≥60 years old), golidocitinib monotherapy and combined chemofree therapy represent viable therapeutic options."

Retrospective data • Hematological Disorders • Hematological Malignancies • Herpes Zoster • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Varicella Zoster

Efficacy and safety of Golidocitinib-based first line regimen in peripheral T-cell lymphoma: A multicenter retrospective study (ASH 2025) - "All patients received golidocitinib combined with chemotherapy, including CHOP-like regimens, chidamide plus thalidomide, or P-GEMOX. Despite the high-risk population, the golidocitinib-based first-line regimen demonstrated promising antitumor efficacy and clinical manageable safety. Further prospective study is warranted to validate the results."

Retrospective data • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Extranodal Natural Killer/T-cell Lymphoma • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • JAK1

Golidocitinib combined with CHOP in newly-diagnosed peripheral T-cell lymphoma: Preliminary Results from A phase 1/2 clinical trial (ASH 2025) - P1/2 | "In Phase 1, patients receive six 21-daycycles of Go-CHOP: oral golidocitinib 150 mg every other day (Qod) on days 1-21 combined with standardCHOP chemotherapy (cyclophosphamide 750 mg/m², doxorubicin 50 mg/m², vincristine 1.4 mg/m² IV onday 1, and prednisone 100 mg po on days 1-5). Preliminary results of golidocitinib in combination with CHOP demonstrated a manageable safety profileand encouraging antitumor activity in newly diagnosed PTCL. This clinical trial is ongoing."

Clinical • P1/2 data • Gastroenterology • Hepatitis B • Hepatology • Infectious Disease • Lymphoma • Nephrology • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Golidocitinib combination therapy as first-line treatment in PTCL: Retrospective data from a single centre (ASH 2025) - "Golidocitinib demonstrated encouraging antitumor efficacy and clinical manageable safetyprofile in combination with CHOP-like chemotherapy in newly-diagnosed PTCL patients. Furtherprospective study is warranted to validate the results. Disclosures: No relevant conflicts of interest to declare.Keywords: Clinical Research, Research, Diseases, Lymphoid Malignancies"

Combination therapy • Retrospective data • Cytomegalovirus Infection • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pneumonia • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Dual anti-HLH and antitumor efficacy of golidocitinib in relapsed/refractory PTCL-associated hemophagocytic lymphohistiocytosis: A retrospective safety and activity analysis (ASH 2025) - "While JAK inhibitors (e.g., ruxolitinib)target the JAK-STAT pathway central to HLH cytokine signaling, their utility in PTCL-associated HLH islimited by substantial hematologic toxicity and lack of proven antitumor efficacy in PTCL. Baseline characteristics included a median age of 56 years (range 28–61), 9 males; lymphoma subtypescomprised extranodal NK/T-cell lymphoma (n=6), angioimmunoblastic T-cell lymphoma (n=5), NK-cellleukemia (n=2), hepatosplenic T-cell lymphoma (n=2), and PTCL-NOS (n=1). 87.5% patients (14/16) hadAnn Arbor stage III–IV disease; median prior lines of anti-lymphoma therapy were 2 (range 1–4); 10patients (62.5%) had ECOG PS ≥2. Systemic HLH manifestations included fever (≥38.5°C) in all patients,cytopenia in 8 (50%) patients, hepatic impairment in 7 (43.8%) patients; elevated biomarkers includedEBV-DNA in 10 patients (62.5%) and elevated sCD25 in 11/11 tested patients (100%)."

Retrospective data • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Hepatology • Hepatosplenic T-cell Lymphoma • Immunology • Infectious Disease • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Rare Diseases • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • IFNG • IL10 • IL6 • TNFA

A Phase II, single-center, single-arm study evaluating the safety and efficacy of golidocitinib in the management of newly diagnosed PTCL (GOLDEN Study) (ASH 2025) - P2 | "Background First-line (1L) therapy for peripheral T-cell lymphoma (PTCL) is cyclophosphamide, doxorubicin, vincristineand prednisone (CHOP)-based, and relapse/refractory (r/r) rates are high (75%) with limited therapeuticoptions thereafter; currently approved agents for r/r PTCL include belinostat and pralatrexate, withoverall response rates (ORR) of <30% and progression free survival (PFS) between 2-4 months. To our knowledge, this study is thefirst to explore a novel oral targeted agent for newly diagnosed pts with a subtype specific PTCL. Thechemotherapy de-escalation and response-adapted design will potentially identify pts who may benefitfrom no chemotherapy or novel agent plus chemotherapy combination."

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK1

Durable responses in the updated 2-year follow-up of patients from a single-center with Relapsed/Refractory peripheral T-cell lymphoma treated with golidocitinib (ASH 2025) - P1/2, P2 | "Responders had a TFH phenotype andexpressed TBX21, which need to be confirmed in a larger cohort. Given the promising results and unmetneed, the ongoing GOLDEN trial aims to evaluate the safety and efficacy of golidocitinib in the frontlinemanagement of PTCL (NCT06630091)."

Clinical • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Prolymphocytic Leukemia • Squamous Cell Carcinoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • ALK • GATA3 • JAK1 • TBX21

Golidocitinib combined with CHOP in treatment-Naïve monomorphic epitheliotropic intestinal T-cell lymphoma: Preliminary results from A phase 2 multicenter, single-arm goal study (ASH 2025) - P2 | "Thestandard first-line treatment, CHOP (Cyclophosphamide, doxorubicin, vincristine, and prednisone), yieldssuboptimal outcomes, highlighting a critical unmet need. Preliminarysingle-cell analysis identifies a baseline JAK/STAT activation signature in malignant cells and a non-immunosuppressive tumor microenvironment as potential biomarkers of response. This regimenrepresents a highly promising new therapeutic strategy for this aggressive lymphoma."

Clinical • P2 data • Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • JAK3 • STAT5B