A Multicenter Study of CAR-T Cells in Primary Ph+All
ConditionALL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Eligibility criteria
Qualifiers
Age ≥ 18 years old, gender not restricted;
Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
Disqualifiers
Subjects with a history of epilepsy or other central nervous system diseases;
Subjects with a prior history of QT interval prolongation or severe cardiac diseases;
Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
Subjects with untreated active infections;
Trial design
Treatments tested in this trial
- CD19 CAR-T cells
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhejiang University
Lead sponsor
Yake Biotechnology Ltd.
Collaborator
Source ClinicalTrials.gov