B cell malignancies
Conditions
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients with definitive diagnosed with B cell malignancies according to the guidline of NCCN. 2.Relapsed or refractory disease after =2 lines of standard therapy and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT. 3.Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR. 4.Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated OR. 5.Measurable disease at time of enrollment: d=1.5cm according to the Lugano critierion. 6.Life expectancy =4 weeks. 7.Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. 8.Estimated Glomerular Filtration Rate (eGFR) = 30 mL/min/1.73 m2 9.Alanine Aminotransferase (ALT) = 5 times the Upper Limit of Normal (ULN) for age Bilirubin = 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is = 3.0 x ULN and direct bilirubin = 1.5 x ULN. 10.Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) = 50% confirmed by echocardiogram. 11. Patients with CD19+ or CD22+ tumor. 12.Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CAR T infusion. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent. 13.Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for at least 12 months following CAR T infusion and until CAR T cells are no longer present by PCR on two consecutive tests. 14.Patients with no activity infection in lung. Written informed consent must be obtained prior to any screening procedures.
Exclusion criteria
Exclusion criteria: 1.Be allergic to any component part in the product of CAR T cells . 2.Acute lymphoblastic blast phase of chronic myeloid leukemia according to the WHO criteria. 3.Solitary extramedullary tumor. 4.Acute GVHD of ?~? levels by the guideline of Glucksberg or B~D levels in severity by IBMTR index; or requirement of systematical treatment within 4 weeks before enrollment. 5.undergone Live vaccines within four weeks. 6.CNS diseases except the invasion by B cell tumors, such as cerebral aneurysm, epilepsy, stroke, Alzheimers disease, and mental disorder. 7.Within 7 days before the start of the drug administration, there was fever or intravenous infusion of anti-microbial treatment due to infection(such as intravenous infusion of antibacterial drugs, antiviral drugs, antifungal drugs), or during the screening period, the researcher judged that there was an uncontrollable, active infection disease. 8.HBsAg+HBV DNA=1.00×10^3 copies/ml; Anti-HCV+;HCV -RNA=1.00×10^2 copies/ml;HIV+. 9.or patients with chronic GVHD needs to be treated 10.undergone Live vaccines within four weeks. 11.Acute GVHD or patients with chronic GVHD needs to be treated; 12.Acute lymphoblastic blast phase of chronic myeloid leukemia; 13.Solitary extramedullary tumor; 14.CNS diseases except the invasion by B cell tumors ; 15.Within 7 days before the start of the drug administration, there was fever or intravenous infusion of anti-microbial treatment due to infection(such as intravenous infusion of antibacterial drugs, antiviral drugs, antifungal drugs), or during the screening period, the researcher judged that there was an uncontrollable, active infection disease; 16.HBsAg+HBV DNA=1.00×10^3 copies/ml; Anti-HCV+;HCV -RNA=1.00×10^2 copies/ml;HIV+; 17.Acquired immunodeficiency or congenital immunodeficiency. 18.Heart failure of III~IV according to the NYHA criteria. 19.History of cancer except in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 5 years prior to the study. 20.Patients with active auto immune or inflammatory disorders(e.g. Guillain Barre Syndrome, SLE). 21.Other protocol-related inclusion/exclusion may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactJianfeng Zhou
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed