Induced-T Cell Like NK Cells for B Cell Malignancies

Last updated: February 6, 2021
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Chronic Lymphocytic Leukemia

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04747093
ITNK-2021
  • Ages 18-65
  • All Genders

Study 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

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

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 asoutlined.
  • 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 noanti-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 Cellsinfusion
  • 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 Cellsinfusion
  • Any situation that may increase the risk of the test or interfere with the testresults

Study Design

Total Participants: 12
Study Start date:
January 29, 2021
Estimated Completion Date:
March 31, 2022

Connect with a study center

  • Department of Hematology,Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

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