NCT03488160

Brief Summary

The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.

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
6

participants targeted

Target at below P25 for not_applicable lymphoma

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable lymphoma

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

March 26, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 26, 2018

Last Update Submit

April 7, 2018

Conditions

Lymphoma

Keywords

lymphoma CAR-T

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure: The overall efficiency

    Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated

    [Time Frame: 3 years]

Study Arms (1)

Single arm

EXPERIMENTAL

The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:the first day,the second day Duration:total two times

Biological: CD19-targeted CAR-T cells

Interventions

CD19-targeted CAR-T cellsBIOLOGICAL

This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..

Single arm

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age is 16 years old, less than 70 years old, sex is not limited, race is not limited;
  • The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation;
  • The patient needs to have a lesion that can be used to detect or evaluate the disease.
  • \~1 score of physical status score of the eastern cancer cooperation group (ECOG).
  • At the time of collection of peripheral white blood cell counts over 1 \* 10\^9/L;
  • Expected survival time \> 90 days;
  • Patients have the ability to know and sign informed consent.

You may not qualify if:

  • Pregnant or lactating women;
  • Uncontrolled infection;
  • HIV infected people, hepatitis B or HCV active stage;
  • Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.).
  • Combined with active central nervous system malignant tumor invading;
  • Has abnormal coagulation function, and there are patients with serious thrombus.
  • Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system.
  • Patients who participated in other clinical trials in the past 30 days or in other clinical trials;
  • Researchers believe that patients are not suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The west area of the First Affiliated Hospital of University of Science & Technology China

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Guolin Wu

    Investigator associate chief physician

    PRINCIPAL INVESTIGATOR

  • Kaiyang Ding

    Chief physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guolin Wu

CONTACT

13855105487wgldoctor@sina.com

Kaiyang Ding

CONTACT

13966672170dingkaiy@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 4, 2018

Study Start

April 10, 2018

Primary Completion

April 10, 2019

Study Completion

April 20, 2019

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)