Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology
Trial Parameters
Brief Summary
The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are: Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months.
Eligibility Criteria
Inclusion Criteria: 1. Patients diagnosed with relapsed or refractory B-cell lymphoma (Diffuse large B-cell lymphoma, Primary diffuse large B-cell lymphoma of the Central Nervous System (CNS), Mantle cell lymphoma, Follicular lymphoma grades 1, 2 or 3a or Marginal lymphoma, including splenic, nodal and MALT). 2. Age over 18 years and under 80 years. 3. Functional status Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Patients with ECOG 2 may be included if motivated by haematological disease (Annex 3). 4. Adequate bone marrow haematopoietic reserve. 5. Life expectancy of at least 2 months. 6. Adequate venous access for lymphapheresis. Absence of contraindications for lymphapheresis. 7. Signed informed consent (patient or legal guardian). Exclusion Criteria: 1. Patients who, in the opinion of a physician, may benefit from other approved potentially curative therapeutic options, including commercial CAR-Ts. 2. Treatment with any experimental or non-commercialised substa