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Induced-T Cell Like NK Cells for B Cell Malignancies

Primary Purpose

B Cell Leukemia, B Cell Lymphoma, B-cell Acute Lymphoblastic Leukemia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-ITNK cells
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Leukemia focused on measuring ITNK Cells, CAR, B Cell Malignancy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with CD19 positive B-cell acute leukemia
  • Eastern Cooperative Oncology Group (ECOG) performance status <2
  • ALT/ AST <3 x normal
  • Bilirubin < 2.0 mg/dl
  • Creatinine < 2.5 mg/dl and less than 2.5x normal for age
  • LVEF< 45%
  • Accept white blood cell collection
  • Provide informed consent

Exclusion Criteria:

  • Previous treatment with investigational gene or cell therapy medicine products
  • Active hepatitis B , hepatitis C or HIV infection
  • Uncontrolled active infection
  • Presence of grade 2-4 acute or extensive chronic GVHD
  • Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
  • Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • Received non-diagnostic purposes major surgery within the past 4 weeks
  • Participated in any other clinical study within the past 4 weeks
  • Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
  • Pregnancy or breast-feeding women
  • Use of prohibited drugs:
  • Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to ITNK Cells infusion
  • Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to ITNK Cells infusion
  • GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to ITNK Cells infusion
  • Any situation that may increase the risk of the test or interfere with the test results

Sites / Locations

  • Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ITNK group

Arm Description

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
OS
overall survival
DFS
disease-free survival

Full Information

First Posted
February 6, 2021
Last Updated
February 6, 2021
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04747093
Brief Title
Induced-T Cell Like NK Cells for B Cell Malignancies
Official Title
Induced-T Cell Like NK Cellular Immunotherapy for Refractory B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimeric antigen receptor (CAR-ITNK cells) is a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of CAR-ITNK cells infusions in patients with relapsed and refractory B cell malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Leukemia, B Cell Lymphoma, B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory
Keywords
ITNK Cells, CAR, B Cell Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ITNK group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CAR-ITNK cells
Intervention Description
CAR-ITNK cells will be infused over 10-15 minutes on Day 0.
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ORR
Description
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time Frame
3 months
Title
ORR
Description
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time Frame
6 months
Title
ORR
Description
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time Frame
12 months
Title
OS
Description
overall survival
Time Frame
1 year
Title
DFS
Description
disease-free survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with CD19 positive B-cell acute leukemia Eastern Cooperative Oncology Group (ECOG) performance status <2 ALT/ AST <3 x normal Bilirubin < 2.0 mg/dl Creatinine < 2.5 mg/dl and less than 2.5x normal for age LVEF< 45% Accept white blood cell collection Provide informed consent Exclusion Criteria: Previous treatment with investigational gene or cell therapy medicine products Active hepatitis B , hepatitis C or HIV infection Uncontrolled active infection Presence of grade 2-4 acute or extensive chronic GVHD Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma, Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc. Any uncontrolled active medical disorder that would preclude participation as outlined. Received non-diagnostic purposes major surgery within the past 4 weeks Participated in any other clinical study within the past 4 weeks Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. Pregnancy or breast-feeding women Use of prohibited drugs: Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to ITNK Cells infusion Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to ITNK Cells infusion GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to ITNK Cells infusion Any situation that may increase the risk of the test or interfere with the test results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ren Lin, MD
Phone
+86-020-62787883
Email
lansinglinren@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi-fa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren Lin, MD
Phone
+86-020-61641613
Email
lansinglinren@hotmail.com
First Name & Middle Initial & Last Name & Degree
Qifa Liu

12. IPD Sharing Statement

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Induced-T Cell Like NK Cells for B Cell Malignancies

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