Natural Killer (NK) Cell Therapy for B-Cell Malignancies

General Information

Summary 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.
Description 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.
Clinical trials phase Phase 1
Start date (estimated) 2021-11-04
End date (estimated) 2024-12-31
Clinical feature
Label B-cell acute lymphoblastic leukemia
Link http://purl.obolibrary.org/obo/DOID_0080638
Description An acute lymphocytic leukemia characterized by too many B-cell lymphoblasts (immature white blood cells) in the bone marrow and blood.

Administrative Information

NCT number NCT05379647
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05379647
Other study identifiers
Name NK-002 (QN-019a)
Source weblink https://clinicaltrials.gov/ct2/show/NCT05379647
Public contact
Email hehuangyu@126.com
Public email hehuangyu@126.com
First name He
Last name Huang
Phone + 86-13605714822
City Zhejiang
Country
China
Sponsors Zhejiang University
Collaborators

Cells

Which differentiated cell type is used
Label natural killer cell
Link http://purl.obolibrary.org/obo/CL_0000623
Description A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells.

Recruitment

Recruitment Status Recruiting
Estimated number of participants 24
Contact institutions/departments