Glucocorticoid-Refractory aGVHDPhase 1/2NCT04941404
A Study of TQ05105 Tablets in Subjects With Glucocorticoid-Refractory Acute Graft-Versus-Host Disease (aGVHD)
A Phase 1/2 study testing TQ05105 tablets in people with Glucocorticoid-Refractory aGVHD, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Glucocorticoid-Refractory aGVHD
- What is being tested?
- TQ05105 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesChina
- Study dates
- 10 Jun 2022to 24 Dec 2024
- Phase
- Phase 1/2
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- Unsatisfactory blood pressure control with more than 2 drugs (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥ 100mmHg) ; (2) Patients with grade ≥2 myocardial ischemia or infarction, arrhythmias (including QTc≥480ms), and grade ≥2 congestive heart failure (New York Heart Association classification); (3) Uncontrolled active infections including bacteria, fungi, parasites or viruses such ascytomegalovirus, Epstein-Barr virus, and human herpes virus 6; (4) Cirrhosis, active hepatitis; (5) Human immunodeficiency virus(HIV) positive, active syphilis; (6) Creatinine clearance rate < 30 mL/min,calculated by Cockcroft Gault formula; (7) Patients with epilepsy and need treatment. 7. Subjects with evidence of recurrence of primary disease or relapsed after allo-HSCT treatment.
- 8. There were grade 2 or higher toxicity (except aGVHD) caused by previous allo HSCT treatment.
- 9. Subjects who received allo-HSCT more than once in the past. 10. Subjects who received more than one kind of systemic treatment for Glucocorticoid-Refractory aGVHD.
- 11. The clinical manifestations were new-onset chronic GVHD or overlapping GVHD syndrome with both acute and chronic GVHD features.
- 12. Allergic to the investigational drug or its ingredients. 13. Subjects who used Janus kinase inhibitor (JAK) therapy after receiving Allo-HSCT.
- 14. Subjects who participated in other clinical trials within 4 weeks before initial administration.
- 15. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for other reasons.
Trial locations and contacts
4 sites in 1 country.
China4 sites
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310012
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215008
Hematology Hospital of the chinese Academy of Medical Sciences
Tianjing, Tianjing, 300020
About this study
Official title: A Single Arm, Open-label, Multicenter, Phase Ib Study of TQ05105 Tablets in Subjects With aGVHD
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
- Conditions
- Glucocorticoid-Refractory aGVHD
- Being tested
- TQ05105 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ05105 tabletsDrug
Participants began oral administration of TQ05105 tablets at 10 mg twice daily (BID),followed by 5 mg or 15 mg BID depending on the situation of the study. twice daily in 28-day cycle until disease progression/intolerance occurs or the sponsor terminates the study.
| Study group | Role | What they receive |
|---|---|---|
| TQ05105 tablets | Experimental | Participants began oral administration of TQ05105 tablets at 10 mg twice daily (BID),followed by 5 mg or 15 mg BID depending on the situation of the study. twice daily in 28-day cycle until disease progression/intolerance occurs or the sponsor terminates the study. Receives: Drug: TQ05105 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug tolerance of the first cycle (Stage 1)
Dose-limiting toxicity events related to the investigational drug occured within 28 days after initial administration
Measured: Day 28 after initial administration
Objective Response Rate (ORR) at Day 28 (Stage 2)
Percentage of subjects with complete response (CR) or very good partial response (VGPR) or partial response (PR) at Day 28
Measured: Day 28 after initial administration
Secondary outcomes (11)
CR Rate at Day 28
Percentage of subjects with CR at Day 28
Measured: Day 28 after initial administration
ORR at Day 28 and Day 56
Percentage of subjects with CR or VGPR or PR at Day 28 and Day 56
Measured: Day 28 and Day 56 after initial administration
Duration of Response (DOR)
From date of first recorded remission to date of first recorded disease progression or date of starting any new systemic therapy for aGVHD
Measured: From initial administration to day 30 after the last administration
Cumulative dose of glucocorticoid at Day 56
Totally and weekly cumulative dose of glucocorticoid of each subject,from initial administration to Day 56 or the day end of therapy
Measured: Day 56 after initial administration
Event Free Survival (EFS）
From the date of initial administration to the date of recurrence/progression of hematological diseases or transplant failure or death from any cause
Measured: From initial administration to Day 30 day after the last administration
Overall Survival (OS)
Time from randomization to death
Measured: From initial administration to day 30 days after the last administration
Incidence of Malignancy Relapse/Progression(MR),Non-Relapse Mortality(NRM)
From the date of first administration to the date of death due to recurrence/progression of non hematological diseases; the date of recurrence or progression of hematological diseases
Measured: From initial administration to 30 days after the last administration
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of AEs and SAEs
Measured: From initial administration to day 30 after the last administration
Tmax
The pharmacokinetic parameters were measured after single and multiple administration: peak time(Tmax)
Measured: 7 days after initial administration
Cmax
The pharmacokinetic parameters were measured after single and multiple administration: peak concentration(Cmax)
Measured: 7 days after initial administration
AUC0-t
The pharmacokinetic parameters were measured after single and multiple administration: area under the blood concentration-time curve (AUC0-t)
Measured: 7 days after initial administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start10 Jun 2022
- Primary completion10 Jul 2023
- Study completion24 Dec 2024
Why it stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoid-Refractory aGVHDStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941404
- Sponsor's protocol ID
- TQ05105-Ib-01
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No