A Study of TQ05105 Tablets in Subjects With Glucocorticoid-Refractory Acute Graft-Versus-Host Dis… (NCT04941404) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of TQ05105 Tablets in Subjects With Glucocorticoid-Refractory Acute Graft-Versus-Host Disease (aGVHD)
Stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
China13 participantsStarted 2022-06-10
Plain-language summary
This is an open-label,single arm,Phase Ib study,in order to evaluate the safety,tolerability, preliminary efficacy and pharmacokinetics of TQ05105 tablets in subjects with Glucocorticoid-Refractory aGVHD
Who can participate
Age range
12 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 participated in the study and signed an informed consent, with good compliance.
. Aged 12-75, gender is not limited.
. Subjects who has received allogeneic hematopoietic stem cell transplantation (allo-HSCT) previously.
. Clinically suspected grades II to IV acute GVHD as per MAGIC guidelines.
. Drug resistance after glucocorticoid treatment.
. Absolute neutrophils count (ANC) \>1×109/L,Platelet(PLT)≥20×109/L within 48 hours before initial treatment.
. Male or female subjects should agree use an adequate method of contraception during the study and within 6 months after the end of the study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
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
Drug tolerance of the first cycle (Stage 1)
Timeframe: Day 28 after initial administration
2
Objective Response Rate (ORR) at Day 28 (Stage 2)
Timeframe: Day 28 after initial administration
Trial details
NCT IDNCT04941404
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
. Subjects with a history of progressive multifocal leukoencephalopathy.
. Subjects with many factors influencing oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.).
. Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, etc..
. Severe respiratory diseases (requiring mechanical ventilation or O2 saturation \< 90%), active tuberculosis, pulmonary hypertension and pulmonary embolism, etc..
. Subjects with a history of psychotropic drug abuse and can not quit or have mental disorders.
. Subjects with any severe and/or uncontrolled disease, including: