relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia
Conditions
Interventions
Low dose level:infuse 0.3×10^6 CAR+ T Cells/kg
Middle dose level:infuse 0.6×10^6 CAR+ T Cells/kg
High dose level:infuse 1.0×10^6 CAR+ T Cells/kg
Sponsors
Hebei Yanda Lu Daopei Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Male or female aged 3-70 years old; 2) Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1); 3) Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions): a) CR not achieved after 2 or more standardized chemotherapy; b) Relapse after CR 4) The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is?5%; 5) HLA antibody(-) or HLA antibody(+) and HLA donor specific antibody(DSA)(-). 6) Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments; 7) Total bilirubin = 50%; 9) No active infection in the lungs, blood oxygen saturation in indoor air is >= 92%; 10) Latest treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatment) must have been completed at least 1 week prior to screening; 11) Estimated survival time >= 3 months; 12) ECOG performance status 0 to 2; 13) Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity to any component of cell product; 2) Prior treatment with any CAR T cell product or other genetically-modified T cell therapies; 3) Uncontrolled CNS leukemia; 4) Burkitt's leukemia/ lymphom; 5) Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome; 6) Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency; 7) Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment; 8) Poor control of hypertension, SBP >= 180mmHg and/or DBP>= 110mmHg; 9) Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 10) History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 11) Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 12) Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed; 13) History of other primary cancer, except for the following conditions: a) Cured non-melanoma after resection, such as basal cell carcinoma of the skin; b) Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival>= 2 years after adequate treatment; 14) Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy; 15) Patients with graft-versus-host disease (GVHD); 16) Prior immunizations with live vaccine 4 weeks prior to screening; 17) If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B > 1000 (if HBV DNA copy number <= 1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection; 18) Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids; 19) Patients who have participated in any other clinical studies within 2 weeks prior to screening; 20) Women pregnant or lactating and fertile patients (male and female) who have pregnancy plans are not willing to accept the medically recognized contraceptive methods during the trial and within 6 months after the end of the trial; women of childbearing age with positive pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity ;Incidence of treatment-emergent adverse events;One month after treatment, CR (complete remission) / CRI (complete remission with incomplete recovery of blood cells) and overall response rate (ORR);Overall survival (OS) (the longest 2 years);Event-free survival (EFS) (the longest 2 years); | — |
Countries
China
Contacts
Public ContactJunFang Yang
Department of General Blood and Immunotherapy, Hebei Yanda Lu Daopei Hospital
Outcome results
None listed