Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.
• Adult patients 18-65 both inclusive;
• Diagnosis of:
∙ Refractory B-ALL (acute lymphocytic leukemia) - relapse after hematopoietic cell transplantation, second or more relapse in patients when transplantation is contraindicated)
‣ Large B-cell lymphoma including DLBCL NOS, lymphoma with high level of malignancy, follicular lymphoma transformed to DLBCL and primary mediastinal lymphoma - refractory or relapse or after at least 2 lines of systemic treatment)
‣ Mantle cell lymphoma (MCL) - relapsing or refractory after at least 2 lines of systemic treatment; Diagnostics of individual diagnoses (criteria for complete remission and partial responses for individual disease entities) was developed on the basis of current (July 2022) recommendations of experts of the Polish Society of Clinical Oncology
• Confirmed CD19 expression on malignant cells;
• General condition measured by ECOG (Eastern Cooperative Oncology Group) ≤ 1;
• Patient's weight between 40 kg - 130 kg
• Sufficient general condition of organs on screening visit:
∙ ALT/AST \<2,5 of UNL and bilirubin \<1,5 mg/dl (\<4 mg/dl for patients with Gilbert syndrome)
‣ Ejection fraction (EF) \>50% confirmed in ECHO with no signs of exudation in pericardium during 6 weeks before screening
‣ Saturation of arterial blood \>93% with no oxygen insufflation, with no significant exudation in pleural cavity
‣ Serum creatinine clearance \>60 ml/min (by Cockcroft-Gault formula);
• Negative result for HCV, HBV, HIV, Syphilis;
• Negative test for pregnancy (serum or urine) in the screening visit and/or 7 days before leucapheresis and 7 days before lymphodepleting therapy in women in reproductive age;
• Assumption of at least 12 months of survival time from screening visit;
⁃ Agreement to maintain sufficient method of contraception from the date of signing informed consent to 6 months after CART therapy;
⁃ The last dose of SARS-CoV-2 vaccination taken at least 6 months prior to study enrollment
⁃ Capable of providing written informed consent;
⁃ Patients polish native language speaking or fluent in polish language