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

Primary Purpose

B-cell Lymphoma, B-cell Acute Lymphoblastic Leukemia

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

QN-019a

Rituximab

Cyclophosphamid

Fludarabine

VP-16

About this trial

This is an interventional treatment trial for B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The First Affiliated Hospital of Medical College of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

QN-019a in Combination with Monoclonal Antibodies

QN-019a Monotherapy

Arm Description

QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.

QN-019a Monotherapy in adult subjects with r/r B-ALL

Outcomes

Primary Outcome Measures

The incidence of subjects with Dose Limiting Toxicities within each dose level cohort

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Incidence, nature, and severity of treatment related adverse events will be evaluated.

Secondary Outcome Measures

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

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

Progression-free survival (PFS) of QN-019a in combination with Rituximab in r/r B-cell Lymphoma

Overall survival (OS) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma

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

Event-free survival (EFS) of QN-019a as monotherapy in r/r B-ALL

Full Information

NCT ID

NCT05379647

First Posted

May 13, 2022

Last Updated

May 17, 2022

Sponsor

Zhejiang University

Collaborators

Hangzhou Qihan Biotech Co.,Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05379647

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 4, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

Hangzhou Qihan Biotech Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Lymphoma, B-cell Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

QN-019a in Combination with Monoclonal Antibodies

Arm Type

Experimental

Arm Description

QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.

Arm Title

QN-019a Monotherapy

Arm Type

Experimental

Arm Description

QN-019a Monotherapy in adult subjects with r/r B-ALL

Intervention Type

Drug

Intervention Name(s)

QN-019a

Intervention Description

Experimental Interventional Therapy

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

Monoclonal Antibody

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamid

Intervention Description

Lympho-conditioning Agent

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Intervention Description

Lympho-conditioning Agent

Intervention Type

Drug

Intervention Name(s)

VP-16

Intervention Description

Lympho-conditioning Agent

Primary Outcome Measure Information:

Title

The incidence of subjects with Dose Limiting Toxicities within each dose level cohort

Time Frame

Day 28

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Incidence, nature, and severity of treatment related adverse events will be evaluated.

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

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

Title

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