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.
This clinical trial is a Phase I/II, pilot, open-label, national, prospective, multicentre, non-randomised, open-label study to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma whose prognosis is less than 2 years. Phase I: Dose escalation phase with a classic 3+3 design, in which three dose levels of TranspoCART19 will be evaluated: 1 x 106 cells/kg, 3 x106 cells/kg and 5 x 106 cells/kg. The maximum number of patients included in this phase will be 18. Phase II: an expansion cohort with the maximum tolerated dose (MTD) determined in Phase I. Patients will be included in the expansion cohort up to a total of 27, including Phase I patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
CAR-T cells therapy
Hospital Clínic
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGInstitut Català d'Oncologia Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGFundación Jiménez Díaz Hospital
Madrid, Madrid, Spain
RECRUITINGVirgen de la Arrixaca University Hospital
El Palmar, Mur, Spain
RECRUITINGClínica Universidad de Navarra
Pamplona, Navarre, Spain
RECRUITINGUniversity Hospital of Navarra
Pamplona, Navarre, Spain
RECRUITINGSalamanca University Health Care Complex
Salamanca, SALAMANCA, Spain
RECRUITINGVirgen del Rocio Hospital
Seville, Sevilla, Spain
RECRUITINGMaximum 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.
Time frame: 1 month
Efficiency
Determine best response rate achieved (overall and complete).
Time frame: 3 month
Procedure-related mortality (PRM)
Rate of mortality, defined as any death not directly caused by lymphoma.
Time frame: 1 month - 3 month
Toxicity assessment
Number of grade II-IV adverse events using Common Toxicity Criteria (CTC) version 5.0
Time frame: 1 month - 3 month - 12 month - 36 month
Response (overall and complete)
Best response rate achieved (overall and complete) following Lugano classification (PET-CT treatment response)
Time frame: 1 month - 3 month - 12 month - 36 month
Duration of response
Time (month) in overall response and complete response.
Time frame: 36 month
Progression-free survival (PFS)
Time (month) between infusion of TranspoCART19 and disease progression or death.
Time frame: 12 month - 24 month
Overall survival (OS)
Time (month) between infusion of TranspoCART19 and death of the patient from any cause.
Time frame: 12 month - 24 month
Perceived general well-being
Evaluation of quality of life using EuroQol-5 Dimension-5 levels (EQ-5D-5L) questionnaire \[score range from 0 (the worst health status for that dimension) to 100 (the best health status)\]
Time frame: 3 month -6 month -12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.