This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 KQ-2002 CAR T cell infusion. The lymphodepleting chemotherapy is administered over 3 days IV to prepare the body for the CAR T cells. The CAR-T cells are infused between 2-7 days after the last dose of chemotherapy. Patients will be followed for two years after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen. Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide. Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3)
The First Affiliated Hospital of Nanchang University;
Nanchang, Jiangxi, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of Dose-limiting toxicity
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Up to 28 days
Incidence and severity of adverse events
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Up to 15 years
Overall response rate
Proportion of patients achieving a response
Time frame: up to 15 years
Progression free survival
Preparative regimen until the documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: up to 15 years
Overall survival
Overall survival (OS) will be determined as the time from the start of the preparative regimen until death
Time frame: up to 15 years
MRD negative response rates( Acute Lymphoblastic Leukemia )
MRD status post infusion,MRD will be performed utilizing flow cytometry or PCR.
Time frame: up to 15 years
Persistence of CD19/CD22 CAR-T cells blood, bone marrow
pk properties of CD19/CD22 CAR-T
Time frame: up to 15 years
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