Induced-T Cell Like NK Cells for B Cell Malignancies

Nanfang Hospital, Southern Medical University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

B Cell Leukemia

B-cell Lymphoma Recurrent

B Cell Lymphoma

B-cell Acute Lymphoblastic Leukemia

B-cell Lymphoma Refractory

Treatments

Biological: CAR-ITNK cells

Study type

Interventional

Funder types

Other

Identifiers

NCT04747093

ITNK-2021

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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