NHLPhase 1NCT07283796
A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 1 study testing HSK47977 in people with NHL, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NHL
- What is being tested?
- HSK47977
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2025to Dec 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form.
- Age ≥18 years, with no gender restriction.
- Pathologically confirmed patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Expected survival >3 months.
- Presence of measurable lesions.
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- Adequate organ function.
- Agreement to undergo pathological tissue biopsy.
- Subjects of childbearing potential must agree to comply with the contraceptive requirements of the study.
- No pregnancy plans from screening until at least 3 months after the last dose of the study drug, and voluntary use of effective contraceptive measures.
Who cannot join
- Concurrent presence of other severe, unstable diseases/conditions that, in the investigator's judgment, make participation in this study unsuitable.
- History of or current severe cardiovascular disease.
- Poorly controlled blood pressure during the screening period.
- Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.
- Electrocardiogram abnormalities determined by the investigator as potentially posing a risk to the subject's safety.
- History of allergies to the investigational drug or its excipients.
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- Inability to discontinue prohibited medications as specified in the protocol during the screening period and throughout the entire study duration.
- Any other conditions that may increase subject risk or interfere with the trial results.
- Any other situations where the investigator deems the subject unsuitable for participation.
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
Chinese Academy of Medical Sciences Blood Diseases Hospital
Tianjin
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
This is a Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years.
- Conditions
- NHL
- Being tested
- HSK47977
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK47977Drug
Taken orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia (Dose Escalation Part): HSK47977 | Experimental | Phase 1a (Dose Escalation Part): dose escalation of HSK47977 at various dose levels Receives: Drug: HSK47977 |
| Phase Ia (Extension Part): HSK47977 | Experimental | Phase 1a (Part B): dose extention of HSK47977 at certain dose levels Receives: Drug: HSK47977 |
| Phase Ib: HSK47977 | Experimental | Phase 1b: dose expansion for HSK47977 at dose of RP2D（Recommended Phase II Dose） Receives: Drug: HSK47977 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Highest dose level at which under 33% of patients in a cohort experience DLT（dose limiting toxicity）
Measured: Within first 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start28 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283796
- Sponsor's protocol ID
- HSK47977-101
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT07283796
- Acronym / sponsor ID
- HSK47977-101
- Conditions
- NHL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Dec 2025 (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 Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia (Dose Escalation Part): HSK47977 | Experimental | Drug: HSK47977Phase 1a (Dose Escalation Part): dose escalation of HSK47977 at various dose levels |
| Phase Ia (Extension Part): HSK47977 | Experimental | Drug: HSK47977Phase 1a (Part B): dose extention of HSK47977 at certain dose levels |
| Phase Ib: HSK47977 | Experimental | Drug: HSK47977Phase 1b: dose expansion for HSK47977 at dose of RP2D（Recommended Phase II Dose） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily sign the informed consent form.
- Age ≥18 years, with no gender restriction.
- Pathologically confirmed patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Expected survival >3 months.
Key exclusion criteria (9 listed)
- Concurrent presence of other severe, unstable diseases/conditions that, in the investigator's judgment, make participation in this study unsuitable.
- History of or current severe cardiovascular disease.
- Poorly controlled blood pressure during the screening period.
- Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.
- Electrocardiogram abnormalities determined by the investigator as potentially posing a risk to the subject's safety.
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 |
|---|---|---|
| HSK47977Taken orally once daily. | Drug | Phase Ia (Dose Escalation Part): HSK47977, Phase Ia (Extension Part): HSK47977, Phase Ib: HSK47977 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Within first 28 days of treatment
Highest dose level at which under 33% of patients in a cohort experience DLT（dose limiting toxicity）
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 19 Dec 2025.
- Individual participant dataSharing planned: No
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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 study testing HSK47977 in people with NHL, run by Haisco Pharmaceutical Group Co., Ltd. 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 10 inclusion and 9 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 19 Dec 2025. 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 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.
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 Yunfen Li (（+86）18108214952, liyunfen@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Within first 28 days of treatment). 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 19 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.