Clinical trial NCT04747093: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: ORR
timeFrame: 3 months
measure: ORR
timeFrame: 6 months
measure: ORR
timeFrame: 12 months
measure: OS
timeFrame: 1 year
measure: DFS
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qi-fa Liu
role: PRINCIPAL_INVESTIGATOR
References: