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GVHD, ChronicPhase 1/2NCT06169722

TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD))

A Phase 1/2 study testing TDI01 suspension in people with GVHD, Chronic, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics 2. Phase II study stage: Primary objective: To evaluate the efficacy Secondary objectives: To evaluate the safety Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
GVHD, Chronic
What is being tested?
TDI01 suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
6 Feb 2024to Aug 2027
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

  • Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
  • Subjects are aged between 18 and 75 years old, regardless of gender;
  • Within 7 days prior to the first dose, the Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
  • Subjects are expected to survive for more than 6 months;
  • Subjects have previously received allogeneic hematopoietic stem cell transplantation;
  • Subjects have received systemic treatment for cGVHD of ≤5 lines but ≥1 line before;
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  • Diagnosed with moderate to severe cGVHD based on NIH criteria, defined as follows:
  • Moderate cGVHD: involvement of ≥3 organs with organ scores of 1 point, or involvement of ≥1 organ (excluding the lung) with organ scores of 2 points, or involvement of the lung with organ scores of 1 point; Severe cGVHD: involvement of ≥1 organ (excluding the lung) with organ scores of 3 points, or involvement of the lung with organ scores of 2 points or higher.
  • Diagnosed with glucocorticoid-resistant/dependent cGVHD based on NIH criteria, meeting any of the following conditions:
  • Subjects who have received at least 2 lines but no more than 5 lines in the past are required to have stable systemic therapy (such as corticosteroids, calcineurin inhibitors, sirolimus, mycophenolate mofetil (MMF), methotrexate, and extracorporeal phototherapy (ECP)) for at least two weeks prior to screening.
  • Subjects who have only received first-line glucocorticoid combined or not combined with calcineurin inhibitors in the past,Diagnosed as glucocorticoid resistant/dependent cGVHD according to NIH criteria, meeting any of the following conditions:
  • Subjects receiving ≥1 mg/kg prednisone (or equivalent dose of glucocorticoids) for at least 1 week but still have disease progression (glucocorticoid-resistant cGVHD); Subjects receiving ≥0.5 mg/kg/day or ≥1 mg/kg every other day prednisone (or equivalent dose of glucocorticoids) for at least 4 weeks but still have persistent disease symptoms without improvement ( glucocorticoid-resistant cGVHD); Subjects who have failed to reduce the glucocorticoid dose twice and have increased the prednisone (or equivalent dose of glucocorticoids) to >0.25 mg/kg/day (glucocorticoid-dependent cGVHD).

Who cannot join

  • The presence of recurrence of the primary disease, or having received treatment for recurrence of the primary disease after allo-HSCT（Hematopoietic stem cell transplant）, or the possible need for rapid immunosuppressive drug withdrawal as emergency treatment for early recurrence of malignant tumors; or the presence of post-transplant lymphoproliferative disorders.
  • Patients with acute GVHD and those with overlapping chronic GVHD.
  • Patients who have suffered from other malignant tumors except for the transplanted tumor within the past 3 years, with the exception of locally curable cancers (i.e., those that have already been cured), such as basal cell carcinoma or squamous cell carcinoma of the skin, cervical or breast carcinoma in situ, or superficial bladder cancer.
  • Unable to swallow medication normally, or with gastrointestinal dysfunction, or deemed by the investigator to potentially affect drug absorption.
  • The presence of active infection, including bacterial, fungal, viral (such as CMV(cytomegalovirus), EBV(epstein-barr virus), etc.) or parasitic infections that require treatment.
  • Poor diabetes control (fasting blood glucose (FBG) > 10 mmol/L).
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  • Inadequate blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg).
  • History of myocardial infarction within 6 months prior to planned initiation of TDI01 treatment, or arrhythmia (CTC AE(adverse event) grade 2 or higher, including QTcF ≥450ms (men), QTcF ≥470ms (women)) and congestive heart failure grade ≥2 (New York Heart Association (NYHA) classification).
  • At the time of screening, forced expiratory volume in 1 second (FEV1) ≤ 39% or NIH pulmonary symptom score of 3.
  • Received systemic treatment for cGVHD within 14 days prior to enrollment; if the dose/regimen of systemic treatment has been stable for at least 2 weeks prior to screening (corticosteroids, calcineurin inhibitors, sirolimus, mycophenolate mofetil (MMF), methotrexate, and extracorporeal photopheresis (ECP)), it is allowed.
  • Patients receiving treatment with Ibrutinib or Ruxolitinib within the past 28 days prior to the first administration of the study drug (except those who have completed washout prior to the first administration of the study drug) are excluded from participation in the study.
  • Patients who participated in other drug or device clinical trials within 4 weeks prior to the screening visit (or 5 half-lives, whichever is longer).
  • Patients receiving treatment with Warfarin or any other coumarin derivative anticoagulant, or patients with a bleeding tendency or coagulation disorder.
  • Patients with positive HBsAg and/or HBcAb and positive HBV-DNA (HBV-DNA negative patients are eligible); patients with positive HCV (hepatitis C virus) antibody and HCV-RNA copy number above the lower limit of detection. Note: Eligible patients with positive hepatitis B surface antigen or hepatitis B core antibody, and patients with hepatitis C, require continuous antiviral therapy to prevent virus activation.
  • Patients with positive HIV antibody.
  • Patients who have previously received treatment with a ROCK2 inhibitor.
  • Patients with a known history of severe allergic reactions to the study drug or its major ingredients.
  • Pregnant or breastfeeding women.
  • Patients with known alcohol or drug dependence.
  • Any other reason that the investigator believes may prevent a patient from participating in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: TDI01 for Treatment of Moderate or Severe Chronic Graft-Versus-Host Disease After Failure of at Least 1 and Not More Than 5 Lines of Systemic Therapy: an Open Label, Multi-center, ph1/2 Study

  1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics
  2. Phase II study stage:

Primary objective: To evaluate the efficacy Secondary objectives: To evaluate the safety

Read the detailed description
  1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy Secondary objectives: To evaluate the population pharmacokinetic characteristics of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy.
  2. Phase II study stage:

Primary objective: To evaluate the efficacy of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy Secondary objectives: To evaluate the safety of TDI01 suspension in treating patients withmoderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy as well as the population pharmacokinetic characteristics of TDI01 suspension in treating these patients.

Conditions
GVHD, Chronic
Being tested
TDI01 suspension
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TDI01 suspensionDrug

    200mg or 400mg oral once a day

Study groups in NCT06169722
Study groupRoleWhat they receive
200mgActive comparator200mg oral once a day
Receives: Drug: TDI01 suspension
400mgActive comparator400mg oral once a day
Receives: Drug: TDI01 suspension
200mg or 400mgActive comparator200mg or 400mg oral once a day
Receives: Drug: TDI01 suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib study stage:The best overall response rate (BORR)

    The best overall response rate (BORR) at 24 weeks.

    Measured: 24 weeks.

  2. Phase Ib study stage:adverse events

    The incidence of adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and treatment-related adverse events (TRAEs).

    Measured: 24 weeks.

  3. Phase II study stage:The best overall response rate (BORR)

    The best overall response rate (BORR) at 24 weeks.

    Measured: 24 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start6 Feb 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06169722
Sponsor's protocol ID
TDI01-YZ-101
Status last verified
Sep 2025
First submitted
5 Dec 2023
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TDI01 suspension in people with GVHD, Chronic, run by Beijing Tide Pharmaceutical 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 12 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib study stage:The best overall response rate (BORR) (time frame: 24 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06169722.

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 26 Sep 2025.

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