Status:

RECRUITING

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

Lead Sponsor:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Conditions:

Chronic Graft Versus Host Disease

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief 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

Eligibility Criteria

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 have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
  • Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;
  • Have any severe or uncontrolled serious illness, including but not limited to,uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;
  • Those who are allergic to the study drug or its components;
  • Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;
  • Subjects judged by the investigator to be unsuitable for enrollment;

Key Trial Info

Start Date :

May 7 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2026

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT06300320

Start Date

May 7 2024

End Date

April 1 2026

Last Update

February 11 2025

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Anhui Provincial Hospital

Hefei, Anhui, China, 230001

2

The 940th hospital of joint logistics support force of Chinese people's liberation army

Lanzhou, Gansu, China, 730050

3

Guangzhou First People's Hospital

Guangzhou, Guangdong, China, 510180

4

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530021

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