LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZhejiang University
About this trial
A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies
Eligibility criteria
Qualifiers
Subjects who are diagnosed with CAEBV according to the Okano revised standard proposed by the Japanese Ministry of Health, Labour and Welfare Research Group for the Prevention of Refractory Diseases;
Active phase: EBV-DNA level in PBMC is higher than 1×10².5 copies/μg DNA, with symptoms and signs of active diseases such as fever, hepatomegaly, splenomegaly, abnormal liver function, decrease of blood three lines, lymphadenopathy, and progressive skin lesions with increased EBV titer in peripheral blood;
inactive phase: EBV-DNA level in PBMC is higher than 1×10².5 copies/μg DNA, without symptoms and signs of active diseases;
The disease has not yet progressed to hematopoietic lymphohistiocytosis (HLH);
Disqualifiers
History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
Pregnant (or lactating) women;
Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
Trial design
Treatments tested in this trial
- LMP1 CAR T-cells
Treatment groups
144 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhejiang University
Lead sponsor
Yake Biotechnology Ltd.
Collaborator
Source ClinicalTrials.gov