CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma
NCT ID: NCT03488160
Last Updated: 2018-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6 participants
INTERVENTIONAL
2018-04-10
2019-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
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
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..
Interventions
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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..
Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
70 Years
ALL
No
Sponsors
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Sinobioway Cell Therapy Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Guolin Wu
Role: PRINCIPAL_INVESTIGATOR
Investigator associate chief physician
Kaiyang Ding
Role: PRINCIPAL_INVESTIGATOR
Chief physician
Locations
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The west area of the First Affiliated Hospital of University of Science & Technology China
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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sinobiowayCT
Identifier Type: -
Identifier Source: org_study_id
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