Induced-T Cell Like NK Cells for B Cell Malignancies

NCT ID: NCT04747093

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2022-03-31

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.

Conditions

B Cell Leukemia; B Cell Lymphoma; B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ITNK group

Group Type: EXPERIMENTAL

CAR-ITNK cells

Intervention Type: BIOLOGICAL

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

Interventions

CAR-ITNK cells

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qifa Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qi-fa Liu

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ren Lin, MD

Role: CONTACT

lansinglinren@hotmail.com

+86-020-62787883

Facility Contacts

Ren Lin, MD

Role: primary

lansinglinren@hotmail.com

+86-020-61641613

Other Identifiers

ITNK-2021

Identifier Type: -

Identifier Source: org_study_id