Cutaneous T-cell Lymphoma (CTCL)Phase 1/2NCT07754890
Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma
A Phase 1/2 study testing golidocitinib and Chidamide in people with Cutaneous T-cell Lymphoma (CTCL), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cutaneous T-cell Lymphoma (CTCL)
- What is being tested?
- golidocitinib and Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2025to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed cutaneous T-cell lymphoma.
- Patients with measurable disease, with or without extracutaneous lesions, and clinical stage IB-IVB.
- Disease that has not responded to or has relapsed after at least one prior systemic therapy (including, but not limited to, total skin electron beam therapy, bexarotene, retinoids, interferon, extracorporeal photopheresis, methotrexate, or chidamide).
- An ECOG performance status of 0 to 2.
- Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L, Platelet count (PLT) ≥80×10⁹/L, Hemoglobin (HGB) ≥90 g/L.
- Adequate organ function: Cardiac function Class 1-2 (NYHA), Left Ventricular Ejection Fraction (LVEF) ≥50%, Alanine Aminotransferase (ALT) < 2.5 × Upper Limit of Normal (ULN), Total Bilirubin (TBil) < 1.5 × ULN, Oxygen Saturation (SpO₂) > 93% on Room Air, estimated Glomerular Filtration Rate (eGFR) based on serum creatinine (sCr) > 60 mL/min/1.73m².
Who cannot join
- Acute myocardial infarction, unstable angina, congestive heart failure, symptomatic arrhythmia within the past 6 months, or significant QT interval prolongation (corrected QT interval >450 ms in males or >470 ms in females).
- Uncontrolled active infection.
- Active tuberculosis infection.
- Active Hepatitis B (HBV DNA > 1×10³ copies/mL) or Hepatitis C (HCV RNA > 1×10³ copies/mL) infection.
- Pregnancy or lactation.
- Any other condition deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Wei Zhang, 13681473557, vv1223@vip.sina.com
About this study
Official title: A Prospective Single-Center Phase I/II Clinical Study of Golidocitinib Combined With Chidamide in Patients With Systemically-Treated Cutaneous T-Cell Lymphoma
This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.
Read the detailed description
of golidocitinib in combination with chidamide and to determine the recommended phase II dose (RP2D). The study follows a standard "3+3" design. The starting dose of golidocitinib is 150 mg every other day, with pre-specified dose levels including 150 mg every other day and 150 mg once daily. Chidamide is administered at a fixed dose of 20 mg twice weekly. In the phase II segment (dose expansion phase), all participants will receive the combination therapy of golidocitinib and chidamide. Golidocitinib will be administered at the RP2D established in the phase I study, while chidamide will continue at the fixed dose of 20 mg twice weekly. Each treatment cycle is defined as 4 weeks. Tumor response will be assessed every 3 treatment cycles, and safety evaluations will be performed every cycle.
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Being tested
- golidocitinib, Chidamide
- Keywords
- cutaneous T-cell lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
golidocitinibDrug
The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study.
ChidamideDrug
Chidamide is administered at a fixed dose of 20 mg twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Golidocitinib and Chidamide | Experimental | The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study. Chidamide is administered at a fixed dose of 20 mg twice weekly. Receives: Drug: golidocitinib; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RP2D)
The RP2D is determined based on the occurrence of dose-limiting toxicities (DLTs) during the first cycle (28 days) of treatment. It is defined as the highest dose level at which fewer than 33% of participants experience a DLT.
Measured: From enrollment to the end of treatment at 4 weeks
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR).
Measured: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause
Secondary outcomes (3)
Complete Response (CR) Rate
Proportion of participants achieving a complete response (CR)
Measured: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause
Progression-Free Survival (PFS)
the time from the first dose of study drug to the first documented disease progression or death
Measured: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause
Overall Survival (OS)
the time from the first dose of study drug to death from any cause
Measured: From enrollment to the end of 2-year follow-up phase or death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start26 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell Lymphoma (CTCL)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754890
- Sponsor's protocol ID
- K8777
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Center Phase I/II Clinical Study of Golidocitinib Combined With Chidamide in Patients With Systemically-Treated Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07754890
- Acronym / sponsor ID
- K8777
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Keywords
- cutaneous T-cell lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.
Detailed description
of golidocitinib in combination with chidamide and to determine the recommended phase II dose (RP2D). The study follows a standard "3+3" design. The starting dose of golidocitinib is 150 mg every other day, with pre-specified dose levels including 150 mg every other day and 150 mg once daily. Chidamide is administered at a fixed dose of 20 mg twice weekly. In the phase II segment (dose expansion phase), all participants will receive the combination therapy of golidocitinib and chidamide. Golidocitinib will be administered at the RP2D established in the phase I study, while chidamide will continue at the fixed dose of 20 mg twice weekly. Each treatment cycle is defined as 4 weeks. Tumor response will be assessed every 3 treatment cycles, and safety evaluations will be performed every cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib and Chidamide | Experimental | Drug: golidocitinib, Drug: ChidamideThe phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study. Chidamide is administered at a fixed dose of 20 mg twice weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed cutaneous T-cell lymphoma.
- Patients with measurable disease, with or without extracutaneous lesions, and clinical stage IB-IVB.
- Disease that has not responded to or has relapsed after at least one prior systemic therapy (including, but not limited to, total skin electron beam therapy, bexarotene, retinoids, interferon, extracorporeal photopheresis, methotrexate, or chidamide).
- An ECOG performance status of 0 to 2.
- Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L, Platelet count (PLT) ≥80×10⁹/L, Hemoglobin (HGB) ≥90 g/L.
Key exclusion criteria (6 listed)
- Acute myocardial infarction, unstable angina, congestive heart failure, symptomatic arrhythmia within the past 6 months, or significant QT interval prolongation (corrected QT interval >450 ms in males or >470 ms in females).
- Uncontrolled active infection.
- Active tuberculosis infection.
- Active Hepatitis B (HBV DNA > 1×10³ copies/mL) or Hepatitis C (HCV RNA > 1×10³ copies/mL) infection.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| golidocitinibThe phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study. | Drug | Golidocitinib and Chidamide |
| ChidamideChidamide is administered at a fixed dose of 20 mg twice weekly. | Drug | Golidocitinib and Chidamide |
Primary outcome
Recommended Phase II Dose (RP2D)
Time frame: From enrollment to the end of treatment at 4 weeks
The RP2D is determined based on the occurrence of dose-limiting toxicities (DLTs) during the first cycle (28 days) of treatment. It is defined as the highest dose level at which fewer than 33% of participants experience a DLT.
Objective Response Rate (ORR)
Time frame: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR).
3 secondary outcomes
Complete Response (CR) Rate
Time frame: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause
Progression-Free Survival (PFS)
Time frame: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause
Overall Survival (OS)
Time frame: From enrollment to the end of 2-year follow-up phase or death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing golidocitinib and Chidamide in people with Cutaneous T-cell Lymphoma (CTCL), run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhang (13681473557, vv1223@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose (RP2D) (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.