relapsed/refractory B cell malignancies
Conditions
Interventions
ICG132 low dose:infusion of 1×10*6 ICG132
ICG132 Intermediate-lower dose:infusion of 2×10*6 ICG132
ICG132 Intermediate-higher dose:infusion of 4×10*6 ICG132
ICG132 High dose:infusion of 8×10*6 ICG132
ICG134 low dose:infusion of 1×10*6 ICG134
Intermediate-lower dose:infusion of 2×10*6 ICG134
ICG134 Intermediate-higher dose:infusion of 4×10*6 ICG134
ICG134 high dose:infusion of 8×10*6 ICG134
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. B-cell lymphoma patients diagnosed by Histopathological or flow cytometry, acute B lymphocytic leukemia (B-ALL) patients diagnosed by flow cytometry ; tumor cells CD19 expression positive (reusable tissue pathology or Take bone marrow cells for flow cytometry or use the pathological tissue at the time of initial diagnosis for review; 2. Relapsed/refractory cases, poor response to conventional chemotherapy: relapsed refractory lymphoma refers to the patient's progression after 2 cycles of standard or conventional first-line chemotherapy, or failure to achieve complete remission (CR) after 4 cycles, or After treatment, CR was achieved but recurrence occurred within 1 year; these cases did not respond after chemotherapy with second- or third-line regimens, or relapsed after autologous/allogeneic hematopoietic stem cell transplantation. Relapsed acute leukemia refers to bone marrow recurrence, molecular relapse or cytogenetic relapse after CR, or bone marrow relapse, molecular relapse or cytogenetic relapse after allogeneic stem cell transplantation (SCT); refractory acute leukemia is defined as de novo B-ALL did not achieve complete remission (CR) following 2 standard induction chemotherapy; chemotherapy refractory was defined as relapsed leukemia did not achieve CR after 1 cycle of standard chemotherapy; or Philadelphia chromosome-positive (Ph+) ALL patients who were untolerated or unresponsive to two types of tyrosine kinase inhibitors (TKI); 3. Patients with relapsed/refractory lymphoma has at least one two-dimensional measurable lesion as the basis for evaluation: for intra-nodal lesions, defined as: long diameter >= 1.5cm and short diameter >= 1.0cm; for extranodal lesions, long diameter should be >= 1.0 cm; morphologically assessed >= 5% of lymphoblasts in the bone marrow, or MRD >10-4 detected by FCM, or specific molecular biomarkers (such as BCR-ABL) in relapsed/refractory ALL) > 10-4, or specific fluorescence in situ hybridization (FISH) results were positive; 4. Aged 14~70 years old; 5. Estimated survival time >= 3 months; 6. Serum creatinine <221.0 umol/L (2.5mg/dl); 7. AST/ALT is less than 3 times the upper limit of the normal value; 8. Blood bilirubin <34.2 umol/L (2.0 mg/dl); 9. ECOG score 0~3; 10. There is a suitable vein for blood cell apheresis or whole blood collection, no blood collection contraindications; 11. Since the effects of CD20/CD19 (ICG132) and CARVAC (ICG134) cell therapy on the fetus are unknown, the serum or urine pregnancy test is negative for women of childbearing age 48 hours before ICG132 and ICG134 cell reinfusion, and agrees during the trial. Take effective contraceptive measures until the last follow-up; 12. Voluntary participation and signed informed consent by the patient or his legal/authorized agent.
Exclusion criteria
Exclusion criteria: 1. Primary central nervous system lymphoma and secondary central nervous system involvement. 2. Failure to preivous CAR T cells or other immunotherapy. 3. Anyone who is allergic to any of the research drugs involved in the program. 4. Severe heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months prior to screening, or any grade 3 (moderate) or grade 4 (severe) heart disease (according to New York Heart Association Functional Classification Method NYHA). 5. Severe lung disease, respiratory insufficiency. 6. Active and uncontrollable infections. 7. Active hepatitis B or hepatitis C. 8. HIV infection 9. Current systemic use of steroids (except inhaled steroids). 10. Suffering from other organ malignancies. 11. Pregnant or lactating women. 12. Drug addiction or mental illness. 13. Can't understand or follow the research plan. 14. Participate in other clinical researchers during the same period. 15. There are other situations that hinder research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactBing Xu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed