CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients 18-65 both inclusive; 2. Diagnosis of: 1. Refractory B-ALL (acute lymphocytic leukemia) - relapse after hematopoietic cell transplantation, second or more relapse in patients when transplantation is contraindicated) 2. 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) 3. 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 3. Confirmed CD19 expression on malignant cells; 4. General condition measured by ECOG (Eastern Cooperative Oncology Group) ≤ 1; 5. Patient's weight between 40 kg - 13