NCT02656147

Brief Summary

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed CD19+ haematological 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
48

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_1 leukemia

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

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 5, 2017

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

January 12, 2016

Last Update Submit

September 1, 2017

Conditions

LeukemiaLymphoma

Keywords

LeukemiaLymphomaCAR γδT

Outcome Measures

Primary Outcomes (1)

  • Adverse events of each patient.

    Adverse events of each patient will be recorded and analysed.

    3 years

Secondary Outcomes (3)

  • Survival time of Anti-CD19 CAR γδT cells in vivo.

    3 years

  • Antitumor Effects

    Every 3 months post treatment up to 24 months

  • Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.

    4 weeks

Study Arms (3)

Experimental: 1

EXPERIMENTAL

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Biological: Anti-CD19-CAR γδT

Experimental: 2

EXPERIMENTAL

Chronic lymphoblastic leukemia with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Biological: Anti-CD19-CAR γδT

Experimental: 3

EXPERIMENTAL

Non-hodgkin lymphoma treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Biological: Anti-CD19-CAR γδT

Interventions

Anti-CD19-CAR γδTBIOLOGICAL

Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)

Experimental: 1Experimental: 2Experimental: 3

Eligibility Criteria

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

You may qualify if:

  • Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
  • KPS\>60.
  • Life expectancy\>3 months.
  • Gender unlimited, age from 18 years to 70 years.
  • CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
  • Patients who have failed at least one line of a standard treatment.
  • No serious mental disorder.
  • Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
  • No other serious diseases(autoimmune disease, immunodeficiency etc.).
  • No other tumors.
  • Patients volunteer to participate in the research.
  • Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to infusion.

You may not qualify if:

  • KPS\<50.
  • Patients are allergic to cytokines.
  • Central nervous system leukemia within 28 days.
  • Uncontrolled active infection.
  • Acute or chronic GVHD.
  • Treated with T cell inhibitor.
  • Pregnancy and nursing females.
  • HIV/HBV/HCV Infection.
  • Other situations we think improper for the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing DOING Biomedical Co., Ltd

Beijing, 100021, China

Location

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Li gangyi, master

    Beijing Doing Biomedical Co., Ltd.

    STUDY CHAIR

Central Study Contacts

Xie yanyun, master

CONTACT

+8615601041145yanyun_xie@doingtimes.com

Li gangyi, master

CONTACT

+8613601204100gangyi_li@doingtimes.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 14, 2016

Study Start

October 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

September 5, 2017

Record last verified: 2017-09

Locations

CN(1)