refractory or relapse B cell hematology malignancies, such as CML lymphoid blast crisis, Ph+ Acute lymphoid leukemia, lymphoma
Conditions
Interventions
case series:CD19 CAR-T\CD22 CAR-T\CD20 CAR-T cell
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
4 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 4 to 70 years old, with an expected survival period of more than 3 months; 2. Recurrent refractory chronic myeloid leukemia lymphoid blast crisis, Ph+ acute lymphoblastic leukemia, B-cell lymphoma; 1) recurrence after allogeneic hematopoietic stem cell transplantation; 2) chemotherapy-resistant or relapse after autologous hematopoietic stem cell transplantation. 3. ECOG score = 2 points (Appendix 1); 4. tumor burden: 0.5x10^9/L, Hb =80 g/L, PLT =60×10^9/L), ALB=35g/L; 6. Cerebrospinal fluid and cranial magnetic resonance examination confirmed: leukemia cells did not invade the central nervous system; 7. Non-severe allergies; 8. There are no other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation) that conflict with this program; 9. No history of other malignant tumors; 10. No serious mental disorders; 11. Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial and within 3 months after the trial; 12. The patient signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women; (2) severe infectious diseases or viral diseases (HIV positive, syphilis, etc.); (3) active hepatitis B or C virus; (4) Patients who have used a high dose of glucocorticoids within 1 week; (5) Those suffering from severe heart, liver, kidney dysfunction, diabetes and other diseases; (6) Patients who have not undergone chemotherapy or hematopoietic stem cell transplantation within 3 months before blood collection; (7) Those who have participated in other clinical studies in the past 3 months or who have been treated with other gene products; (8) Patients with lymphocyte vector transduction difficulties (<20%) or ineffective amplification (<5 times).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Progress Free Survival;minimal residual disease;toxic and adverse effects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Remission; | — |
Countries
China
Contacts
Public ContactSun Kai
He'nan Provincial People's Hospital
Outcome results
None listed