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Induced-T Cell Like NK Cells for B Cell Malignancies

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ClinicalTrials.gov Identifier: NCT04747093
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 29, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. ORR [ Time Frame: 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.

  2. ORR [ Time Frame: 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.

  3. ORR [ Time Frame: 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.

  4. OS [ Time Frame: 1 year ]
    overall survival

  5. DFS [ Time Frame: 1 year ]
    disease-free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747093


Contacts
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Contact: Ren Lin, MD +86-020-62787883 lansinglinren@hotmail.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ren Lin, MD    +86-020-61641613    lansinglinren@hotmail.com   
Principal Investigator: Qifa Liu         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Qi-fa Liu Nanfang Hospital of Southern Medical University
More Information
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04747093    
Other Study ID Numbers: ITNK-2021
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qifa Liu, Nanfang Hospital of Southern Medical University:
ITNK Cells
CAR
B Cell Malignancy
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
 Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin