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

Not Applicable

• Conditions: Lymphoma
• Interventions: Biological: CD19-targeted CAR-T cells

• Registration Number: NCT03488160
• Lead Sponsor: Sinobioway Cell Therapy Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2018-03-26
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-04
• Last Update Submitted: 2018-04-07
• Study Start: 2018-04-10
• Last Update Posted: 2018-04-10
• Primary Completion: 2019-04-10
• Study Completion: 2019-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	CD19-targeted CAR-T cells	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

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure: The overall efficiency	[Time Frame: 3 years]	Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated

Trial Locations

Locations (1)

The west area of the First Affiliated Hospital of University of Science & Technology China; 🇨🇳 Hefei, Anhui, China