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.
Male or female,≥18 years old;
Second or greater relapse (CD20 regimens must be included) OR
Refractory to first-line chemotherapy or relapse within 1 year OR
Relapse within 1 year of auto-HSCT.
Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h
Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；
active bleeding, or venous thromboembolic event
Sequential
KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
Biological/VaccineCD19/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)
Incidence of Dose-limiting toxicity
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence and severity of adverse events
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Overall response rate
Proportion of patients achieving a response
Progression free survival
Preparative regimen until the documentation of disease progression or death due to any cause, whichever occurs first.
Overall survival
Overall survival (OS) will be determined as the time from the start of the preparative regimen until death
MRD negative response rates（ Acute Lymphoblastic Leukemia ）
MRD status post infusion，MRD will be performed utilizing flow cytometry or PCR.
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Rong Tao
Lead sponsor
Fudan University
Sponsor institution
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Collaborator
