This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma. This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL. Up to 22-36 patients will be enrolled.
This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma. This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 24-36 patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Experimental Interventional Therapy
Monoclonal Antibody
Lympho-conditioning Agent
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGThe incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, nature, and severity of treatment related adverse events will be evaluated.
Time frame: Day 28
Objective response rate (ORR) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma
Time frame: From baseline tumor assessment up to approximately 2 years after last dose of QN-019a
Duration of response (DOR) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma
Time frame: Up to approximately 2 years after last dose of QN-019a
Progression-free survival (PFS) of QN-019a in combination with Rituximab in r/r B-cell Lymphoma
Time frame: Up to approximately 2 years after last dose of QN-019a
Overall survival (OS) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma
Time frame: Up to approximately 2 years after last dose of QN-019a
Determination of the pharmacokinetics (PK) of QN-019a cells in peripheral blood
The PK of QN-019a in peripheral blood will be reported as the relative percentage of product (QN-019a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Time frame: Up to approximately 2 years after last dose of QN-019a
Event-free survival (EFS) of QN-019a as monotherapy in r/r B-ALL
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Lympho-conditioning Agent
Lympho-conditioning Agent
Time frame: Up to approximately 2 years after last dose of QN-019a