NCT02992834

Brief Summary

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant or refractory CD19+ B cell lymphoma.

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
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_4

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

December 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

December 12, 2016

Last Update Submit

December 12, 2016

Conditions

Lymphoma, B Cell

Outcome Measures

Primary Outcomes (1)

  • overall survival

    5 year

Secondary Outcomes (2)

  • progression-free survival

    56 day

  • Objective Response Rate

    56 day

Study Arms (2)

IL-2 pre-treated CD19 cells

ACTIVE COMPARATOR

Initial therapy: IL-2 (interleukin,IL)stimulated, CD28-ζ-vector (cluster of differentiation 28,CD28)transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion

Biological: IL-2 pre-treated CD19 cells

IL-7/IL-15 pre-treated CD19 cells

ACTIVE COMPARATOR

Initial therapy: IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion

Biological: IL-7/IL-15 pre-treated CD19 cells

Interventions

IL-2 pre-treated CD19 cellsBIOLOGICAL

IL-2 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion

IL-2 pre-treated CD19 cells
IL-7/IL-15 pre-treated CD19 cellsBIOLOGICAL

IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion

IL-7/IL-15 pre-treated CD19 cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrollment for enough male or female patients with CD19+ hematological malignancies, without regimens for cure (autologous or allogeneic stem cell transplantation), and having a poor prognosis (several months to 2 years) under current optional regimens
  • Age ranges from 18 to 70 years old
  • Expected survival time longer than 12 weeks
  • Performance status score 0-2
  • Pathologically confirmed CD19+ lymphoma (CD19+ follicular lymphoma, Mantle cell lymphoma, diffuse large B cell lymphoma) and meets at least one of follows:
  • having received at least 2-4 cycles of combined chemotherapy (excluding monoclonal antibody monotherapy, such as rituximab) but do not reach a complete response; recurrent disease; not applicable for conventional stem cell transplantation; being partial responsible or stable but not complete responsible after the latest therapy
  • recurrence develops after stem cell transplantation
  • diagnosis confirmed but refusing to receive conventional therapy
  • Creatinine\<2.5 mg/dl；
  • alanine aminotransferase/aspartate aminotransferase lower than 3 folds of normal range
  • Bilirubin\<2.0 mg/dl；
  • Venous channel available and no contraindications for leukocyte collection
  • Reliable contraception from the beginning to 30 days after discontinuation of therapy
  • Informed consent signed

You may not qualify if:

  • Central nerve system invasion with symptoms
  • Other concurrent uncontrolled malignancies
  • Hepatitis B infection or active period of hepatitis C, HIV infection
  • Other uncontrolled diseases hampering the intervention in the study
  • Coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious cardiovascular or cerebrovascular diseases.
  • Grade 2-3 or uncontrolled hypertension
  • History of uncontrolled mental disease
  • Not suitable for participation judged by researchers
  • Immunosuppressive agents administered due to organ transplantation, not including recent or current inhaled corticosteroid
  • Medical history of mental diseases or abnormities of lab tests might increase the risks of participation in study or drug administration, or interfering the results
  • Screening suggesting transfection efficiency of targeting cells lower than 30% or cell expansion deficiency under CD3/CD28 (cluster of differentiation 3,CD3)stimulation (less than 5 folds)
  • Unstable pulmonary embolism, deep venous thromboembolism or other major arterial/venous thromboembolism events develop in 30 days before the randomization. If anti-coagulation therapy is received, the treatment dose should reach stability before the randomization.
  • Pregnancy or lactation, or pregnancy planned during the study or in 2 months after the study
  • Reliable contraception not accepted during the study or in 2 months after the study. Female subjects are required to provide negative results from serum or urine pregnancy test 48 hours before therapy
  • Systematic active or uncontrolled infection (excluding infection of urinary tract or upper respiratory tract infection) in 14 days before the randomization
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

Location

Related Publications (2)

  • Rafiq S, Purdon TJ, Daniyan AF, Koneru M, Dao T, Liu C, Scheinberg DA, Brentjens RJ. Optimized T-cell receptor-mimic chimeric antigen receptor T cells directed toward the intracellular Wilms Tumor 1 antigen. Leukemia. 2017 Aug;31(8):1788-1797. doi: 10.1038/leu.2016.373. Epub 2016 Dec 7.

    PMID: 27924074BACKGROUND

  • Minagawa K, Jamil MO, Al-Obaidi M, Pereboeva L, Salzman D, Erba HP, Lamb LS, Bhatia R, Mineishi S, Di Stasi A. In Vitro Pre-Clinical Validation of Suicide Gene Modified Anti-CD33 Redirected Chimeric Antigen Receptor T-Cells for Acute Myeloid Leukemia. PLoS One. 2016 Dec 1;11(12):e0166891. doi: 10.1371/journal.pone.0166891. eCollection 2016.

    PMID: 27907031BACKGROUND

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jingting Jiang, Professor

    The First People's Hospital of Changzhou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingting Jiang, Professor

CONTACT

jjtnew@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 14, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2020

Study Completion

January 1, 2022

Last Updated

December 14, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)