NCT02963038

Brief Summary

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.

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_1

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_1

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

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 28, 2017

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 28, 2016

Last Update Submit

April 27, 2017

Conditions

B-Cell LeukemiaB-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Tumor load

    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

    Up to 24 months

Secondary Outcomes (1)

  • CAR T cell persistence

    Up to 24 months

Other Outcomes (1)

  • B cell number and immunoglobulins in peripheral blood

    Up to 12 months

Study Arms (1)

CD19 CAR T cells

EXPERIMENTAL

Autologous CD19-targeting CAR T cells

Biological: Autologous CD19-targeting CAR T cells

Interventions

Autologous CD19-targeting CAR T cellsBIOLOGICAL

Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

CD19 CAR T cells

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The treat history meeting the following criteria:
  • Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
  • Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
  • One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
  • There is a measurable lesions before treatment at least;
  • ECOG score≤2;
  • To be aged 1 to 70 years;
  • More than a month lifetime from the consent signing date

You may not qualify if:

  • Serious cardiac insufficiency, left ventricular ejection fraction\<50;
  • Has a history of severe pulmonary function damaging;
  • Merging other malignant tumor;
  • Merging uncontrolled infection;
  • Merging the metabolic diseases (except diabetes);
  • Merging severe autoimmune diseases or immunodeficiency disease;
  • patients with active hepatitis B or hepatitis C;
  • patients with HIV infection;
  • Has a history of serious allergies on Biological products (including antibiotics);
  • Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No.2 Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, B-CellLymphoma, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma

Study Officials

  • Jianmin Luo, PhD & MD

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jianqiang li, PhD & MD

CONTACT

+8631189928689limmune@gmail.com

Jianmin Luo, PhD & MD

CONTACT

+8631166002304

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 15, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2021

Last Updated

April 28, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)