Relapsed or Refractory B-cell Lymphoma
Conditions
Interventions
Sponsors
Beijing Shijitan Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed positive B-cell lymphoma, such as CD19, was clinically identified as relapsed or refractory; 2. ECOG score was 0-2 when selected; 3. The life expectancy is more than 3 months; 4. Aged 18 to 75 years old male and female; 5. Have at least one two-dimensional measurable target lesion as the basis for evaluation; 6. At least 21 days apart from the last chemotherapy, and blood routine: WBC (>3.5 *10^9/L), Hb (>80g/L), ANC (>1.5 *10^9/L), Plt (>80 *10^9/L); 7. Important organs function is normal: liver function test: total bilirubin 50%) was measured by echocardiography; 11. It can tolerate the collection of monocytes through venous pathway; 12. Women of childbearing age must be confirmed not to be pregnant by pregnancy test and take effective contraceptive measures within 12 months after the end of the experiment. All male subjects take contraceptive measures during the period of the test and within 3 months after the last administration; 13. Understand and sign informed consent and voluntarily accept clinical trials.
Exclusion criteria
Exclusion criteria: 1. After allogeneic hematopoietic stem cell transplantation, or have received other allogeneic organ transplantation or xenotransplantation; 2. During the first four weeks of admission, active bacteria, viruses, fungi, mycobacteria, parasitic infections (excluding nail bed fungal infections) or any major systemic infections requiring intravenous antibiotic treatment or hospitalization (except for the treatment of neoplastic fever) were known; 3. Suspected active or latent tuberculosis patients; 4. Severe cardiopulmonary, liver and kidney dysfunction or other organ dysfunction, unexplained history of syncope; active autoimmune diseases; 5. Allergic constitutions or known allergies to the active ingredients, excipients or rodent-derived products or foreign proteins of any drug included in this test; 6. Pregnant and lactating women; 7. Subjects had a history of alcoholism or drug abuse, and had severe mental illness; 8. Receiving or having received any gene therapy products; 9. Those who used any monoclonal antibodies or participated in other clinical trials within 3 months before admission to the group; 10. Those who had been vaccinated with (attenuated) live virus vaccine within one month before admission; 11. It is difficult for peripheral blood monocytes to amplify CAR-T cells to meet the needs of treatment by stimulation in vitro; 12. Subjects who used prednisone > 5 mg/day or equivalent corticosteroids within 2 weeks before cell collection; 13. Central nervous system disease or tumor infiltration; 14. Patients with other malignant tumors or major diseases; 15. Subjects who were unable to comply at the trial and/or follow-up stages; 16. Other researchers do not think it is suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events;overall response Summary;overall survival rate;Median Survival Time;event free survival; | — |
Countries
China
Contacts
Public ContactXiaosong Zhong
Beijing Shijitan Hospital, Capital Medical University
Outcome results
None listed