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.
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).
Age over 18 years and under 80 years.
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).
Adequate bone marrow haematopoietic reserve.
Patients who, in the opinion of a physician, may benefit from other approved potentially curative therapeutic options, including commercial CAR-Ts.
Treatment with any experimental or non-commercialised substance in the four weeks prior to recruitment, or who are actively participating in another therapeutic clinical trial.
Diagnosis of another neoplasm, past or present. Patients who have been in complete remission for more than 3 years, or with a history of non-melanoma skin cancer or completely resected carcinoma in situ may be included. A current or previous history of clonal T-lymphocytes is also an exclusion criterion.
Early relapse after allogeneic haematopoietic stem cell transplantation (less than 3 months for lymphapheresis, less than 6 months for TranspoCART19 infusion) or patients on active immunosuppressive treatment for graft-versus-recipient disease (corticosteroids or other systemic immunosuppressants).
Single group
CAR-T cells therapy
Biological/VaccineCAR-T cells therapy
Maximum tolerated dose (MTD)
Determine the maximum tolerated dose (MTD) and/or recommended dose of TranspoCART19 cells in patients with relapsed or refractory B-cell lymphoma.
Efficiency
Determine best response rate achieved (overall and complete).
Procedure-related mortality (PRM)
Rate of mortality, defined as any death not directly caused by lymphoma.
Toxicity assessment
Number of grade II-IV adverse events using Common Toxicity Criteria (CTC) version 5.0
Response (overall and complete)
Best response rate achieved (overall and complete) following Lugano classification (PET-CT treatment response)
Duration of response
Time (month) in overall response and complete response.
Molecular and cell biology exploratory objectives: Response dynamics
Assess disease response dynamics by Positron Emission Tomography (PET) \- Calculate SUVmax value
Molecular and cell biology exploratory objectives: Response dynamics
Assess disease response dynamics by Positron Emission Tomography (PET) \- Calculate tumour metabolic volume (mL)
Molecular and cell biology exploratory objectives: Response dynamics
Assess disease response dynamics by Positron Emission Tomography (PET) \- Calculate total lesion glycolysis (mL)
Molecular and cell biology exploratory objectives: In vivo survival of TranspoCART19 cells in peripheral blood
Evaluation of time (days) for TranspoCART19 cell survival determined by flow cytometry
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Instituto de Investigación Biomédica de Salamanca
Lead sponsor
Spanish Clinical Research Network - SCReN
Collaborator
Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Collaborator
Fundación para la Investigación Biomédica del Hospital 12 de Octubre
Collaborator
