NCT04747093

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 6, 2021

Last Update Submit

February 6, 2021

Conditions

B Cell LeukemiaB Cell LymphomaB-cell Acute Lymphoblastic LeukemiaB-cell Lymphoma RecurrentB-cell Lymphoma Refractory

Keywords

ITNK CellsCARB Cell Malignancy

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    12 months

Secondary Outcomes (5)

  • ORR

    3 months

  • ORR

    6 months

  • ORR

    12 months

  • OS

    1 year

  • DFS

    1 year

Study Arms (1)

ITNK group

EXPERIMENTAL
Biological: CAR-ITNK cells

Interventions

CAR-ITNK cellsBIOLOGICAL

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

ITNK group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Leukemia, B-CellLymphoma, B-CellBurkitt Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphomaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Qi-fa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Lin, MD

CONTACT

+86-020-62787883lansinglinren@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 10, 2021

Study Start

January 29, 2021

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

CN(1)