Back to results

CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma

Primary Purpose

Lymphoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CD19-targeted CAR-T cells

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring lymphoma CAR-T

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
0~1 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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Primary Outcome Measure: The overall efficiency

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03488160

First Posted

March 26, 2018

Last Updated

April 7, 2018

Sponsor

Sinobioway Cell Therapy Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03488160

Brief Title

CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma

Official Title

CAR-T Cell Therapy for Relapsed / Refractory CD19 Positive Clinical Study on the Safety and Effectiveness of Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 10, 2018 (Anticipated)

Primary Completion Date

April 10, 2019 (Anticipated)

Study Completion Date

April 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinobioway Cell Therapy Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

lymphoma CAR-T

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

CD19-targeted CAR-T cells

Intervention Description

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..

Primary Outcome Measure Information:

Title

Primary Outcome Measure: The overall efficiency

Description

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

Time Frame

[Time Frame: 3 years]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 0~1 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guolin Wu

Phone

13855105487

wgldoctor@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kaiyang Ding

Phone

13966672170

dingkaiy@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guolin Wu

Organizational Affiliation

Investigator associate chief physician

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kaiyang Ding

Organizational Affiliation

Chief physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guolin Wu

Phone

13855105487

wgldoctor@sina.com

First Name & Middle Initial & Last Name & Degree

Kaiyang Ding

Phone

13966672170

dingkaiy@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma

We'll reach out to this number within 24 hrs