CD7 CAR-T Cells in T-cell Lymphoma/Leukemia
ConditionT Lymphoblastic Leukemia/Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen University General Hospital
About this trial
T-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.
In this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian;
According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed with T-cell lymphoma;
Disqualifiers
Those who have a history of allergy to any of the ingredients in cell products;
Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L;
Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (LVEF) < 50%;
Abnormal lung function, blood oxygen saturation under indoor air < 92%;
Trial design
Design model
Single group
Treatments tested in this trial
CD7 CAR-T cells
Biological/Vaccinepatient was subjected to 0.5-2×10\^6 cells/kg of CD7 CAR- T
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
TEAEs
Adverse events during treatment
Time frame
From date of initial treatment to the 30 days after treatmentSecondary outcomes
1
overall response rate
the proportion of complete and partial response patients
Time frame
baseline and 8 weeks, up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov