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Study on Immunotherapy with HSP-CAR19M and Drug Combination for Adults with B-cell Non-Hodgkin Lymphoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called B-cell non-Hodgkin lymphoma, which includes specific subtypes such as large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma. These are conditions where the body's immune cells grow uncontrollably. The study is testing a new treatment called HSP-CAR19M, which is a form of immunotherapy. Immunotherapy is a treatment that uses the body's own immune system to fight cancer. In this study, a patient's own immune cells, specifically T cells, are collected, modified in a lab to better recognize and attack cancer cells, and then returned to the patient's body.

The purpose of this study is to evaluate the safety and effectiveness of this new treatment. Participants will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor how the body responds to the treatment and any side effects that may occur. The trial will also compare the new treatment to existing treatments to see if it offers any advantages.

In addition to HSP-CAR19M, other medications used in the study include Beneflur (containing fludarabine phosphate), Genoxal (containing cyclophosphamide monohydrate), RoActemra (containing tocilizumab), and Levact (containing bendamustine hydrochloride). These medications are used to prepare the body for the new treatment or to manage symptoms. Some participants may receive a placebo, which looks like the treatment but does not contain the active medicine. The study will continue until the end of 2025, with regular check-ups to assess the treatment's impact on the cancer and the patient's overall health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
Eligibility criteria include age between 18 and 70 years, measurable disease, and specific types of lymphoma such as large B-cell non-Hodgkin lymphoma, mantle cell lymphoma, and follicular lymphoma.
Step 2
Pre-treatment preparation
Before starting the treatment, a series of tests and evaluations are performed to ensure safety and readiness for the trial.
These tests may include blood tests, imaging studies like PET-CT or CT scans, and assessments of heart and lung function.
Step 3
Treatment phase
The treatment involves the administration of genetically modified T cells, known as HSP-CAR19M, through an intravenous infusion.
Prior to the infusion of HSP-CAR19M cells, a conditioning regimen is administered. This includes medications such as fludarabine phosphate and cyclophosphamide monohydrate, given intravenously to prepare the body for the T cell infusion.
The infusion of HSP-CAR19M cells is monitored closely to evaluate safety and any potential side effects.
Step 4
Post-treatment monitoring
After the infusion, regular follow-up visits are scheduled to monitor the patient's response to the treatment and to manage any side effects.
Additional medications, such as tocilizumab, may be administered intravenously if needed to manage specific side effects.
Step 5
Long-term follow-up
Long-term follow-up is conducted to assess the efficacy of the treatment and to monitor for any late-onset side effects.
This phase includes periodic health assessments and may continue for several months or years, depending on the study's requirements.

Who can join the trial?

13 criteria

Age must be between 18 and 70 years old.
Must have a disease that can be measured using special scans like PET-CT or CT.
For patients with Diffuse Large B-Cell Lymphoma (DLBCL): Must have a confirmed diagnosis and the disease must have returned or not responded to two treatments, including specific drugs like doxorubicin and anti-CD20 monoclonal antibody, or returned after a special type of stem cell transplant.
For patients with Mantle Cell Lymphoma (MCL): Must have a confirmed diagnosis and the disease must have returned or not responded after two treatments, including an anti-CD20 monoclonal antibody and a BTK inhibitor, or returned after a special type of stem cell transplant in patients who previously received a BTK inhibitor.
For patients with Follicular Lymphoma (FL): Must have a confirmed diagnosis and the disease must have returned or not responded to two treatments, including an anti-CD20 monoclonal antibody, or meet specific criteria for early relapse within the first 24 months after starting initial treatment.
General health condition must be between 0 and 2 on the ECOG scale, which measures daily living abilities.
Breathing tests must show certain levels: FEV1, DLCO, and FVC must be more than 40% of the expected normal values.
Heart function must be adequate, with a left ventricular ejection fraction greater than 40%.
Liver function tests must show total bilirubin and transaminases less than 4 times the normal limit, unless due to lymphoma.
Kidney function must show creatinine less than 2 times the normal limit and clearance greater than 40 mL/min.
Tests for HIV, HBV, and HCV must be negative. If positive for HBV or HCV, a viral load of 0 must be confirmed.
No uncontrolled active infections from bacteria, viruses, or fungi.
Must sign an informed consent form before starting any procedures.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Virgen del Rocío University Hospital
Verified
Sevilla, Spain

Trial locations

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Investigated drugs

Autologous Memory T Cells are a type of immune cell therapy used in this trial. These T cells are collected from the patient's own blood and are specifically selected for their CD62L expression. They are then expanded, which means they are grown in large numbers outside the body. After expansion, they are genetically modified using a lentiviral vector. This modification allows the T cells to express a chimeric antigen receptor (CAR) that targets the CD19 antigen, which is commonly found on the surface of B-cell non-Hodgkin lymphoma cells. The CAR also includes co-stimulatory sequences 4-1-BB and CD3ζ, which help enhance the T cells' ability to attack and destroy the cancer cells. This therapy aims to evaluate its safety, toxicity, and effectiveness in treating patients with B-cell non-Hodgkin lymphoma.

What is already known about the treatment

Autologous CAR T-Cell Therapy – This treatment involves the administration of genetically modified T cells, which are a type of white blood cell, to target specific cancer cells. The therapy is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory large B-cell non-Hodgkin lymphoma, mantle cell lymphoma, and follicular lymphoma. The main therapeutic indication is to help the immune system recognize and attack cancer cells. At the molecular level, the T cells are modified to express a chimeric antigen receptor (CAR) that specifically targets the CD19 antigen found on the surface of certain cancer cells. This therapy falls under the pharmacological classification of immunotherapy, as it uses the body's own immune system to fight cancer.

Investigated diseases

Large B-cell non-Hodgkin lymphoma
This is a type of cancer that originates in the lymphatic system, specifically affecting B cells, which are a type of white blood cell. It is characterized by the rapid growth of large abnormal B cells in the lymph nodes, spleen, or other organs. As the disease progresses, it can spread to other parts of the body, leading to symptoms such as swollen lymph nodes, fever, and weight loss.
Mantle cell lymphoma
This is a rare form of non-Hodgkin lymphoma that arises from B cells located in the "mantle zone" of the lymph node. It typically presents with swollen lymph nodes, and as it advances, it may involve the bone marrow, spleen, and gastrointestinal tract. The disease is known for its aggressive nature and tendency to spread quickly.
Follicular lymphoma
This is a slow-growing type of non-Hodgkin lymphoma that originates from B cells in the lymph nodes. It often presents with painless swelling of the lymph nodes and can remain stable for years before progressing. Over time, it may transform into a more aggressive form of lymphoma, leading to more pronounced symptoms.