TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD)) (NCT06169722) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD))
China60 participantsStarted 2024-02-06
Plain-language summary
1. Phase Ib study stage:
Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics
2. Phase II study stage:
Primary objective: To evaluate the efficacy Secondary objectives: To evaluate the safety
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
✓. Subjects are aged between 18 and 75 years old, regardless of gender;
✓. Within 7 days prior to the first dose, the Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
✓. Subjects are expected to survive for more than 6 months;
✓. Subjects have previously received allogeneic hematopoietic stem cell transplantation;
✓. Subjects have received systemic treatment for cGVHD of ≤5 lines but ≥1 line before;
✓. Diagnosed with moderate to severe cGVHD based on NIH criteria, defined as follows:
✓. Diagnosed with glucocorticoid-resistant/dependent cGVHD based on NIH criteria, meeting any of the following conditions:
Exclusion criteria
✕. The presence of recurrence of the primary disease, or having received treatment for recurrence of the primary disease after allo-HSCT（Hematopoietic stem cell transplant）, or the possible need for rapid immunosuppressive drug withdrawal as emergency treatment for early recurrence of malignant tumors; or the presence of post-transplant lymphoproliferative disorders.
✕. Patients with acute GVHD and those with overlapping chronic GVHD.
✕. Patients who have suffered from other malignant tumors except for the transplanted tumor within the past 3 years, with the exception of locally curable cancers (i.e., those that have already been cured), such as basal cell carcinoma or squamous cell carcinoma of the skin, cervical or breast carcinoma in situ, or superficial bladder cancer.
What they're measuring
1
Phase Ib study stage:The best overall response rate (BORR)
Timeframe: 24 weeks.
2
Phase Ib study stage:adverse events
Timeframe: 24 weeks.
3
Phase II study stage:The best overall response rate (BORR)
✕. Unable to swallow medication normally, or with gastrointestinal dysfunction, or deemed by the investigator to potentially affect drug absorption.
✕. The presence of active infection, including bacterial, fungal, viral (such as CMV(cytomegalovirus), EBV(epstein-barr virus), etc.) or parasitic infections that require treatment.
✕. Inadequate blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg).
✕. History of myocardial infarction within 6 months prior to planned initiation of TDI01 treatment, or arrhythmia (CTC AE(adverse event) grade 2 or higher, including QTcF ≥450ms (men), QTcF ≥470ms (women)) and congestive heart failure grade ≥2 (New York Heart Association (NYHA) classification).