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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborator: Hangzhou Qihan Biotech Co.,Ltd.
• Treatments: Cyclophosphamide; Fludarabine; Rituximab

Criteria

Key Inclusion Criteria:

• Diagnosis of B-cell lymphoma or B-ALL as described below:

B-cell Lymphoma:

• Histologically documented lymphomas expected to express CD19 and CD20

• Relapsed/refractory disease following at least two prior systemic treatment regimens, or relapsed after the autologous hematopoietic stem cell transplantation (HSCT)

B-ALL:

• Diagnosis of B-ALL that expected to express CD19

• Relapsed/refractory disease following prior systemic treatment regimens

ALL SUBJECTS:

• Provision of signed and dated informed consent form (ICF)

• Age ≥ 18 years old

• Stated willingness to comply with study procedures and duration

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Adequate organ function as defined in the protocol

• Donor specific antibody (DSA) to QN-019a: MFI <= 2000

• At least 3 weeks after the last systemic immunochemotherapy treatment

• The estimated survival days are expected to be over 3 months

Key Exclusion Criteria:

ALL SUBJECTS:

• Females who are pregnant or lactating

• Evidence of insufficient organ function as defined in the protocol

• ECOG Performance Status ≥2

• Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T/CAR-NK within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy

• Currently receiving or likely to require systemic immunosuppressive therapy

• Known active central nervous system (CNS) involvement by malignancy. Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease

• Clinically significant cardiovascular disease as defined in the protocol

• Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection

• Donor specific antibody (DSA) to QN-019a: MFI > 2000

• Other comorbid conditions and concomitant medications prohibited as per study protocol

• Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject