A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease (NCT06300320) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
China52 participantsStarted 2024-05-07
Plain-language summary
This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Voluntary and signed informed consent, good compliance;
* Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.
* Received allogeneic hematopoietic stem cell transplantation;
* Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)
* Received systemic therapies for cGVHD;
* Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;
* Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ;platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function;
* Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study
Exclusion Criteria:
* Currently present or occured other malignancies within 3 years prior to first administration;
* Known or suspected active acute graft versus host disease (aGVHD);
* Presence of infection requiring treatment within 7 days prior to randomization;
* Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;
* Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;
* Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;
* Those who ha…
What they're measuring
1
Objective response rate (ORR) at 24 weeks
Timeframe: Up to 24 weeks
Trial details
NCT IDNCT06300320
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.