CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma (NCT03029338) | Clinical Trial Compass
CompletedPhase 1
CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma
China20 participantsStarted 2017-06-08
Plain-language summary
In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10\^6/kg-1×10\^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell lymphoma.
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
* Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal(ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min.
* Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
* Patients should sign informed consent form.
Exclusion Criteria:
* Patients with central nervous system involvement by lymphoma.
* Prior chemotherapy within 2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load.
* Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have≥ grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.
* Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
* Major surgery within 4 weeks before enrollment.
* Impaired …
What they're measuring
1
Number of patients with adverse events
Timeframe: 2 years
Trial details
NCT IDNCT03029338
SponsorInstitute of Hematology & Blood Diseases Hospital, China