Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies (NCT05127135) | Clinical Trial Compass
UnknownPhase 1
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
China30 participantsStarted 2020-01-22
Plain-language summary
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
Who can participate
Age range3 Years – 70 Years
SexALL
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Inclusion criteria
✓. Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
✓. No alternative treatment options deemed by investigator;
✓. Measurable or detectble disease at time of enrollment;
✓. Age 18-70 years old, no gender and race limited;
✓. Eastern cooperative oncology group (ECOG) performance status of ≤2;
✓. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
✓. Estimated life expectancy \> 12 weeks deemed by investigator;
✓. Serum creatinine ≤ 1.5 upper limit of normal (ULN);
Exclusion criteria
✕. Women in pregnancy or lactation;
✕. Uncontrolled infection;
✕. Active hepatitis B virus or hepatitis C virus infection;
✕. Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
✕. Prior treatment with an allogeneic stem cell transplant within 100 days;
What they're measuring
1
Incidence of Treatment-related grade≥3Adverse Events or SAE