CD19 positive relapsed/refractory B-cell lymphoma
Conditions
Interventions
Experimental group:CART treatment sequential ASCART treatment of sequential ASCT
control group:CART cell alone treatment
Sponsors
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 65 years old, the expected survival period is greater than 3 months; 2. Relapsed and refractory B lymphocyte malignant hematological disease diagnosed as CD19+, the patient currently has no other effective treatment plan; or the patient voluntarily chooses to infusion anti-CD19 CAR-T sequential ASCT as the first treatment plan; 3. B-cell tumors include the following 4 types: (1) Indolent B-cell lymphoma (FL, MZL); (2) Invasive B-cell lymphoma (DLBCL, BL, MCL); 4. ECOG score =2.5x10^9/L, lymphocyte count>0.5x10^9/L, Hb >=80 g/L, PLT >=60x10^9/L), ALB>=35g/L; 7. Cerebrospinal fluid and craniocerebral magnetic resonance examination confirmed: the tumor does not invade the central nervous system; 8. Non-severe allergies; 9. There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation); 10. No history of other malignant tumors; 11. No serious mental disorders; 12. Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the test and within 3 months after the test; 13. The patient himself agrees to participate in this clinical study and signs the "Informed Consent".
Exclusion criteria
Exclusion criteria: (1) Women during pregnancy or lactation (women of childbearing age need to undergo pregnancy examination); (2) Severe infectious diseases or viral diseases (HIV positive, syphilis, etc.); (3) Active viral hepatitis B or C; (4) Patients who have used a lot of corticosteroids within 1 week; (5) People with severe heart, liver, kidney insufficiency, diabetes and other diseases; (6) Those who have participated in other clinical studies in the past 3 months, or have been treated with other gene products in the past; (7) Difficulties in lymphocyte vector transduction (<10%) or ineffective amplification (<5 times) occurred during the assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Count of blood cells;Subsets of CD19 CART cells;cytokines;morphology of bone marrow cell;function of live and kidney;Dectation of minimal residual disease; | — |
Countries
China
Contacts
Public ContactHao Siguo
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicne
Outcome results
None listed