Lymphoma Clinical Trial
Official title:
CAR-T Cell Therapy for Relapsed / Refractory CD19 Positive Clinical Study on the Safety and Effectiveness of Lymphoma
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The west area of the First Affiliated Hospital of University of Science & Technology China | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Sinobioway Cell Therapy Co., Ltd. |
China,
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] |
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