B lymphoblastic leukemia /B cell lymphoma
Conditions
Interventions
Single arm:CD19+CXCR5 cell therapy
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All subjects or legal guardians must sign the EC-approved informed consent form personaly before beginning any screening process; 2. Patients aged 18-75 (excluding borderline values) with B-lymphoblastic leukemia/B-cell lymphoma; 3. Meet the clinical criteria in refractory relapsed patients with B-lymphoblastic leukemia/B-cell lymphoma. The definition of refractory includes: There is no response to the latest treatment (The most recent response of latest treatment was PD;Response to the most recent treatment was SD and maintained for no more than 6 months); Inappropriate or unwilling to receive autologous stem cell transplantation, or refractory to ASCT. Subjects have been adequately treated before and their Medical? history should include at least: (1) Used anti-CD20 monoclonal antibody (rituximab), unless the investigator ensure the tumor is CD20 negative; (2) Chemotherapy containing anthracyclines; 4. According to the revised response criteria for malignant lymhoma of IWG (2007 version), there is at least one measurable lesion at baseline; 5. Assess survival period >=12 weeks; 6. ECOG (eastern tumor cooperative group) score was 0 or 1 in the baseline period; 7. Adequate organ functions: (1) Renal function: Scr =60 ml/min/173m2; (2) liver function: ALT91% in indoor air; 8. Hemodynamic stability and left ventricular ejection fraction (LVEF) >=45% as determined by echocardiography or multichannel radionuclide angiography (MUGA); 9. Sufficient bone marrow reserve without blood transfusion, defined as: Absolute neutrophil count (ANC) > 1.000/mm3; Absolute lymphocyte count (ALC) >=300/mm3; Platelet >=50.000/mm3; Hemoglobin > 8.0g/dl; 10. To collected single or peripheral blood cells by non-mobilization for the CAR-T cell production; 11. Patients using the following drugs shall conform to the following conditions: Steroids: The treatment dose of steroids must be discontinued 2 weeks before the infusion of CD19+CXCR5. Physiological replacement doses of steroids are allowed, however; Immunosuppression:Any immunosuppressive drug must be discontinued at least 4 weeks before inclusion; Antiproliferative therapy in addition to lymphatic depletion chemotherapy in the two weeks prior to infusion; CD20 antibody-related treatment must be discontinued within 4 weeks or 5 half-lives (older) prior to infusion; CNS disease prevention must be stopped 1 week before the infusion of CD19+CXCR5 (e.g., intrathecal injection of methotrexate); 12. Women of child-bearing age and all male subjects must agree to use the effective contraceptive method for at least 12 months after the infusion of CD19+CXCR5 and until two consecutive PCR tests show no more CAR-T cells in the body.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received any anti-CD19 / anti-CD3 treatment or any other anti-CD19 treatment; 2. Patients who have previously received any gene therapy product, including CAR-T therapy; 3. Patients with detectable cerebrospinal fluid malignant cells or brain metastases, or patients with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma; 4. Patients with testicular invasion, including those who have had the testicle removed; 5. Patients with current or history of central nervous system diseases, such as epileptic seizure, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease involving the central nervous system; 6. Patients who received chemotherapy except lymphocyte clearance chemotherapy within 2 weeks before the infusion of CD19+CXCR5; 7. Patients who have received other study drugs within the screening stage first 30 days ; 8. Patients receiving radiotherapy within 2 weeks before infusion; 9. Patients with active hepatitis b (defined as HBV DNA test value > 500 IU/mL) or hepatitis c (HCV RNA positive); 10. HIV-positive or Treponema pallidum positive patients; 11. Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood culture at less than 72 hours before infusion); 12. Patients with unstable angina and/or myocardial infarction within 6 months prior to screening; 13. Patients with previous or concurrent malignant tumors, except for the following: Basal-cell or squamous cell carcinomas that have been adequately treated (adequate wound healing is required prior to study enrollment); Carcinoma in situ of cervical or breast cancer, with no signs of recurrence at least 3 years prior to the study after curative treatment; The primary malignant tumor has been completely resected and in complete remission for >=5 years; 14. Female patients during pregnancy or lactation; 15. Arrhythmia patients without medical management control; 16. Patients receiving oral anticoagulant therapy within 1 week before CAR-T cell infusion; 17. Patients who have previously received any adoptive T cell therapy; 18. Active neuroautoimmune or inflammatory disorders (e.g. Guillian-barre syndrome, amyotrophic lateral sclerosis); 19. The investigator considers should not be included in this clinical trial for other conditions, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactYirong Jiang, Jun Jia
Dongguan People's Hospital
Outcome results
None listed