A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • TQ05105 tablets

Treatment groups

52 Participants
are divided into 1 treatment group

Locations

12
Anhui Provincial Hospital230001, HefeiAnhui, China
The 940th hospital of joint logistics support force of Chinese people's liberation army730050, LanzhouGansu, China
Guangzhou First People's Hospital510180, GuangzhouGuangdong, China
The First Affiliated Hospital of Guangxi Medical University530021, NanningGuangxi, China

Sponsors and collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Lead sponsor