TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD)) (NCT06169722) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD))
China60 participantsStarted 2024-02-06
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Diagnosed with moderate to severe cGVHD based on NIH criteria, defined as follows:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase Ib study stage:The best overall response rate (BORR)
Timeframe: 24 weeks.
2
Phase Ib study stage:adverse events
Timeframe: 24 weeks.
3
Phase II study stage:The best overall response rate (BORR)
. Diagnosed with glucocorticoid-resistant/dependent cGVHD based on NIH criteria, meeting any of the following conditions:
Exclusion criteria
. 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.
. 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).