Induced-T Cell Like NK Cells for B Cell Malignancies

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04747093

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
B Cell Leukemia B Cell Lymphoma B-cell Acute Lymphoblastic Leukemia B-cell Lymphoma Recurrent B-cell Lymphoma Refractory	Biological: CAR-ITNK cells	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Induced-T Cell Like NK Cellular Immunotherapy for Refractory B Cell Malignancies

Actual Study Start Date :

Jan 29, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ITNK group	Biological: CAR-ITNK cells CAR-ITNK cells will be infused over 10-15 minutes on Day 0.

Arm

Intervention/Treatment

Experimental: ITNK group

Biological: CAR-ITNK cells

CAR-ITNK cells will be infused over 10-15 minutes on Day 0.

Outcome Measures

Primary Outcome Measures

Adverse Events [12 months]

Secondary Outcome Measures

ORR [3 months]
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 [6 months]
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 [12 months]
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 [1 year]
overall survival
DFS [1 year]
disease-free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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