RecruitingPhase 1Phase 2NCT06378190

Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology

Multicentre Phase I/IIa Study of Infusion of Autologous Peripheral Blood T Lymphocytes Expanded and Genetically Modified Using Sleeping Beauty Family Transposons to Express a Chimeric Antigenic Receptor With Anti-CD19 Specificity Conjugated to the 4-1BB Co-stimulatory Region and CD3z and huEGFRt Signal Transmission (TranspoCART19) in Patients With Relapsed or Refractory B-cell Lymphoma


Sponsor

Instituto de Investigación Biomédica de Salamanca

Enrollment

27 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is offering a new CAR T-cell therapy — where immune cells are taken from a patient, genetically modified to attack cancer, and then returned to the body — to people with relapsed or treatment-resistant B-cell lymphoma using an improved manufacturing technology. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with relapsed or refractory B-cell lymphoma (including DLBCL, mantle cell lymphoma, follicular lymphoma grades 1–3a, marginal zone lymphoma, or primary CNS DLBCL) - Your general health is reasonably good (ECOG 0–1, or ECOG 2 if caused by blood cancer) - You have adequate bone marrow function and venous access for the cell collection procedure - Your expected survival is at least 2 months **You may NOT be eligible if...** - You have other serious conditions that would make cell collection or treatment unsafe - Your cancer has not relapsed and is still responding to treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCAR-T cells therapy

CAR-T cells therapy


Locations(8)

Hospital Clínic

Barcelona, Barcelona, Spain

Institut Català d'Oncologia Hospital

L'Hospitalet de Llobregat, Barcelona, Spain

Fundación Jiménez Díaz Hospital

Madrid, Madrid, Spain

Virgen de la Arrixaca University Hospital

El Palmar, Mur, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

University Hospital of Navarra

Pamplona, Navarre, Spain

Salamanca University Health Care Complex

Salamanca, SALAMANCA, Spain

Virgen del Rocio Hospital

Seville, Sevilla, Spain

View Full Details on ClinicalTrials.gov

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NCT06378190


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