Phase I Clinical Trial of MB.CART19.1 CD19 Chimeric Antigen Receptor (CAR)T Cells in Relapsed or Refractory CD19-Positive Haematological Malignancy

Metro North Hospital and Health Service0 个研究点目标入组 25 人开始时间: 2021年6月18日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•(1) Age equal to or greater than 18 years old
•(2) Relapsed or refractory CD19-positive haematological malignancy, with prior documentation of CD19 expression by flow cytometry and/or immunohistochemistry. Re-biopsy is mandatory for relapses following treatment with blinatumomab.
•(3) ECOG less than or equal to 2
•(4) Life expectancy equal to or greater than 12 weeks
•(5) Adequate cardiac function with LVEF equal to or greater than 45%
•(6) Adequate pulmonary reserve with pulse oximetry O2 saturation equal to or greater than 90% on room air
•(7) Adequate renal function: serum creatinine equal to or less than 1.5 x upper limit of normal (ULN) or eGFR or CrCl equal to or greater than 50 mL/min/1.73m2
•(8) Adequate liver function: ALT and AST equal to or less than 5 x ULN unless due to malignant infiltration, and total bilirubin equal to or less than 1.5 x ULN
•(9) Adequate bone marrow reserve: absolute neutrophil count (ANC) equal to or greater than 1.0 x 10e9/L and platelet count equal to or greater than 50 x 10e9/L, unless secondary to malignant infiltration
•(10) Absolute lymphocyte count (ALC) equal to or greater than 300 /µL or absolute CD3+ T cell count equal to or greater than 150 /µL (within 30 days of signing informed consent)
•(11) Males and females of child-bearing potential must agree to highly effective contraception for at least 1 year after CAR T cell therapy. Women of child bearing potential must have a negative serum pregnancy test.

•(1) Participants who have undergone prior allogeneic HSCT and have active acute Graft Versus Host Disease (GVHD) equal to or greater than grade 2 or chronic GVHD requiring equal to or greater than 0.5mg/kg prednisolone or other systemic immunosuppressants
•(2) Participants who are HIV positive, or have active Hepatitis C (HCV) or Hepatitis B (HBV). Participants who are HBV core antibody positive, with negative HBV surface antigen and HBV DNA are eligible but require anti-viral prophylaxis. Participants who have previously cleared HCV are eligible if viral clearance has been confirmed by a hepatologist.
•(3) Active non-haematological malignancy, excluding adequately treated carcinoma in situ and non-melanoma skin cancer
•(4) Active uncontrolled bacterial, fungal or viral infections
•(5) Active uncontrolled neurological disorders, including uncontrolled seizure disorders
•(6) Uncontrolled CNS involvement due to leukaemia or lymphoma
•(7) Significant cardiac disease, including NYHA stage 3 or 4 congestive heart failure; myocardial infarction, unstable angina or coronary artery revascularisation within 6 months of signing informed consent; and clinically significant cardiac arrhythmia, excluding atrial fibrillation.
•(8) Prior treatment with other CAR T cell product or gene-modified cell product
•(9) Pregnancy or breast feeding.
•(10) Patients who are eligibile for and are able to access TGA-approved CAR T cell therapy within the clinically required timeframe

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