A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease (NCT04944043) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease
China45 participantsStarted 2021-06-25
Plain-language summary
This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Understood and signed an informed consent form.
* ≥18 years old, Karnofsky Performance Scale of ≥60, life expectancy ≥ 6 months.
* Has received allogeneic hematopoietic stem cell transplantation (alloSCT).
* Clinically diagnosed moderate to severe cGVHD according to NIH Consensus Criteria.
* Has received systemic or topical corticosteroids therapy and confirmed steroid-refractory/dependent cGVHD according to NIH Consensus Criteria.
* Has received at least 1 lines of therapy for cGVHD.
* Adequate laboratory indicators.
* No pregnant or breastfeeding women, and a negative pregnancy test.
Exclusion Criteria:
* Has active acute GVHD.
* Has previously failed to respond to JAK inhibitors for GVHD, or who had used JAK inhibitors within 4 weeks before the first administration.
* Has uncontrollable active infections or infections requiring systematic treatment within 7 days before the first administration.
* Development of other basic diseases.
* Has malignant tumors within 3 years.
* Has multiple factors affecting oral medication.
* Has substance abuse or a psychotic disorder.
* Has severe and / or uncontrolled disease.
* Allergic to drugs or its constituents.
* Has participated in any other clinical trials within 4 weeks before first administration.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
What they're measuring
1
Maximal Tolerable Dose (MTD)
Timeframe: Baseline up to 4 weeks
2
Recommended phase II dose (RP2D)
Timeframe: Baseline up to 4 weeks
3
Best Overall Response Rate (BOR)
Timeframe: Baseline up to 96 weeks
Trial details
NCT IDNCT04944043
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.