Clinical trial NCT03488160: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Keywords: lymphoma CAR-T
Lead sponsor: Sinobioway Cell Therapy Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-04
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome Measure: The overall efficiency
timeFrame: [Time Frame: 3 years]
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The west area of the First Affiliated Hospital of University of Science & Technology China
state: Anhui
Study officials:
affiliation: Investigator associate chief physician
name: Guolin Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Chief physician
name: Kaiyang Ding
role: PRINCIPAL_INVESTIGATOR
References: