NCT05379647

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

QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. 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.

Conditions

• B-cell Lymphoma
• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	QN-019a	Experimental Interventional Therapy
DRUG	Rituximab	Monoclonal Antibody
DRUG	Cyclophosphamid	Lympho-conditioning Agent
DRUG	Fludarabine	Lympho-conditioning Agent
DRUG	VP-16	Lympho-conditioning Agent

Timeline

• Start date: 2021-11-04
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2022-05-18
• Last updated: 2022-05-18

Locations

1 site across 1 country: China