Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia

NCT07682792 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 26-x150
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-institution pilot study of single-agent golidocitinib enrolling up to 24 patients in two cohorts: a) advanced-stage mycosis fungoides/Sézary syndrome (MF/SS), n=12, or b) T-cell large granular lymphocytic leukemia (T-LGLL) requiring treatment, n=12. Patients will receive single agent golidocitinib at the previously established dose of 150 mg QD as determined in the phase I and II studies of golidocitinib.

Conditions

Mycosis Fungoides/Sezary Syndrome; T-cell Large Granular Lymphocytic Leukemia

Keywords

JAK inhibitor; Golidocitinib; Cutaneous T-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the proportion of evaluable patients achieving complete response (CR) or partial response (PR). As assessed according to the Global Response Criteria for CTCL and E5998 prospective clinical trial for T-LGLL.

  At four months after start of treatment

Secondary Outcomes (7)

• Best overall response rate

  Through completion of treatment (estimated to be 12 months)

• Complete response rate

  Through completion of treatment (estimated to be 12 months)

• Duration of response

  From date of first response through disease progression (estimated to be 22 months)

• Time to maximum response

  Through completion of treatment (estimated to be 12 months)

• Clinical benefit rate

  Through completion of treatment (estimated to be 12 months)

Study Arms (2)

Cohort 1: Advanced-stage mycosis fungoides/Sézary syndrome (MF/SS) - Golidocitinib

EXPERIMENTAL

Patients with advanced-stage MF/SS will take golidocitinib as a 150 mg pill orally each day of a 28-day cycle.

Drug: Golidocitinib

Cohort 2: T-cell large granular lymphocytic leukemia (T-LGLL) - Golidocitinib

EXPERIMENTAL

Patients with T-LGLL will take golidocitinib as a 150 mg pill orally each day of a 28-day cycle.

Drug: Golidocitinib

Interventions

Golidocitinib DRUG

Golidocitinib is a JAK1 kinase inhibitor taken orally at a dose of 150mg.

Cohort 1: Advanced-stage mycosis fungoides/Sézary syndrome (MF/SS) - Golidocitinib; Cohort 2: T-cell large granular lymphocytic leukemia (T-LGLL) - Golidocitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB with measurable disease and/or detectable blood involvement based on the Global Response Criteria for CTCL
• Received at least one prior line of systemic therapy.
• At least 18 years of age.
• ECOG performance status ≤ 2
• Adequate counts and organ function as defined below:
• Serum Creatinine ≤ 2 x IULN
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subject's Body Surface Area \[BSA\])
• Serum total bilirubin ≤ 1.5 x IULN if no liver involvement, or ≤ 2 x IULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver involvement.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN, or ≤ 5 x IULN if documented hepatic involvement with lymphoma.
• Patients must be able to swallow pills.
• The effects of golidocitinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use highly effective methods of contraception for the duration of study participation and for 3 months after the last dose of golidocitinib for female patients and female partners of male patients, or for 6 months after the last dose of golidocitinib for male patients and male partners of female patients. Should a woman become pregnant or suspect she is pregnant or a male patient suspect he has impregnated another while participating in this study, s/he must inform the treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
• Diagnosis of T-LGLL defined as: CD3+CD8+ cell population \> 650/mm3 or CD3+CD8+CD57+ population \> 500/mm3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis).
• Note: patients with MDS-like T-LGLL may be included with PI approval even if CD3+CD8+ cell population is \< 650/mm3, though +TCR is required. Natural-Killer (NK) LGL is also permitted, provided there is a clonal NK-cell population noted with \> 500 cells/mm3.
• Untreated T-LGLL or failed at least one line of frontline therapy.

You may not qualify if:

• Patients with active CNS lymphoma.
• A history of other malignancy, with the exception of prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Currently receiving any other investigational agents.
• Concomitant use of another systemic therapy for MF/SS. Patients must have the following minimum washout from previous treatments:
• At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy (TSEBT).
• At least 4 weeks for systemic cytotoxic anticancer agents or for tumor-targeting monoclonal antibodies (mAbs), with the exception of alemtuzumab, for which the washout is at least 16 weeks.
• At least 2 weeks or 5 half-lives (whichever is shorter) for systemic retinoids, interferons, vorinostat, romidepsin, and denileukin diftitox, or anticancer investigational agents that are not defined as immunotherapy.
• At least 1 week for topical retinoids, nitrogen mustard, or imiquimod.
• Gastrointestinal disorders, or any other condition that may significantly interfere with absorption of the study medication by the investigator's assessment.
• Uncontrolled active infection requiring IV antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (e.g., urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable.
• Current known active or chronic infection with HIV, hepatitis B, or hepatitis C. All patients will require serologic testing to be performed within 6 months prior to C1D1.
• Patients with chronic HBV are defined as patients with positive hepatitis B serology: Patients with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g. polymerase chain reaction \[PCR\] test) to be enrolled and will require prophylactic antiviral treatment initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s).
• Patients with chronic HCV infection are defined as patients with a positive hepatitis C antibody (anti-HCV) test:
• Patients with a positive anti-HCV antibody test require a quantitative HCV RNA viral load test (e.g., polymerase chain reaction \[PCR\] test) to determine eligibility. Patients with a positive anti-HCV antibody and a detectable/positive HCV RNA (i.e., active chronic HCV infection) are not eligible.
• Patients with a positive anti-HCV antibody and an undetectable/negative HCV RNA (i.e., prior resolved infection or previously treated and cured HCV) are eligible for enrollment without antiviral treatment.

Sponsors & Collaborators

• Dizal Pharmaceuticals: collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Mycosis Fungoides; Sezary Syndrome; Leukemia, Large Granular Lymphocytic; Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• Neha Mehta-Shah, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neha Mehta-Shah, MD

CONTACT

557-747-2108; mehta-n@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): September 30, 2032
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)