Induced-T Cell Like NK Cells for B Cell Malignancies

B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747093
• Other study ID #: ITNK-2021
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 29, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Ren Lin, MD
• Phone: +86-020-62787883
• Email: lansinglinren[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• B Cell Leukemia
• B Cell Lymphoma
• B-cell Acute Lymphoblastic Leukemia
• B-cell Lymphoma Recurrent
• B-cell Lymphoma Refractory
• Leukemia
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		12 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	OS	overall survival	1 year
Secondary	DFS	disease-free survival	1 year