Efficacy and Safety of CD7 CAR-T in Newly Diagnosed High-Risk T-LBL/ALL
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
This study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL/ALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Adverse reactions will be followed up and observed, and relevant data on treatment efficacy will be collected to evaluate the safety, efficacy, and cell metabolic kinetics characteristics of CAR-T cell therapy for the patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≤18 years with newly diagnosed T-LBL/ALL.
Have completed induction chemotherapy and achieved CR1, with bone marrow MRD < 0.01%.
High/very high-risk or poor induction response patients.
High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation.
Disqualifiers
Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment.
Complicated with other progressive malignant tumors.
Presence of active and/or uncontrolled infections that have not been effectively managed.
Complicated with severe autoimmune diseases or congenital immunodeficiency.
Trial design
Design model
Single group
Treatments tested in this trial
CD7 CAR-T cell intravenous infusion
Biological/VaccineCD7 CAR-T cells, single intravenous infusion
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: CD7 CAR-T cell injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CR Rate
CR+CRi
Time frame
28 days after CD7 CAR-T cell infusionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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