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

NCT05379647 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hangzhou Qihan Biotech Co.,Ltd.

    collaborator INDUSTRY

  • Zhejiang University

    lead OTHER

Principal Investigators

  • He Huang, PhD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379647 on ClinicalTrials.gov