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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488160
• Other study ID #: sinobiowayCT
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2018
• Last updated: April 7, 2018
• Start date: April 10, 2018
• Est. completion date: April 20, 2019

Study information

• Verified date: April 2018
• Source: Sinobioway Cell Therapy Co., Ltd.
• Contact: Guolin Wu
• Phone: 13855105487
• Email: wgldoctor[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: April 20, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age is 16 years old, less than 70 years old, sex is not limited, race is not limited;

2. 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;

3. The patient needs to have a lesion that can be used to detect or evaluate the disease.

4. 0~1 score of physical status score of the eastern cancer cooperation group (ECOG).

5. At the time of collection of peripheral white blood cell counts over 1 * 10^9/L;

6. Expected survival time > 90 days;

7. Patients have the ability to know and sign informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;

2. Uncontrolled infection;

3. HIV infected people, hepatitis B or HCV active stage;

4. Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.).

5. Combined with active central nervous system malignant tumor invading;

6. Has abnormal coagulation function, and there are patients with serious thrombus.

7. 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.

8. Patients who participated in other clinical trials in the past 30 days or in other clinical trials;

9. Researchers believe that patients are not suitable for the study.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• CD19-targeted CAR-T cells
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..

Locations

Country	Name	City	State
China	The west area of the First Affiliated Hospital of University of Science & Technology China	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Sinobioway Cell Therapy Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]