Study on the Safety of HSP-CAR30 Immunotherapy for Patients with Relapsed or Refractory CD30+ Hodgkin and Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying two types of blood cancers: Classical Hodgkin lymphoma and non-Hodgkin CD30+ T cell lymphoma. These are conditions where the body’s lymphatic system, which is part of the immune system, is affected by cancer. The study is testing a new treatment called HSP-CAR30, which is a type of immunotherapy. Immunotherapy is a treatment that uses the body’s own immune system to fight cancer. In this study, the patient’s own T cells, a type of white blood cell, are modified in the lab to better recognize and attack cancer cells.

The purpose of the study is to evaluate the safety and potential side effects of the HSP-CAR30 treatment. Participants will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor participants closely for any side effects or reactions to the treatment. This will help researchers understand how the treatment works and how it affects the body.

In addition to HSP-CAR30, the study involves other medications that may be used in combination with the main treatment. These include Levact (bendamustine hydrochloride), Fludarabina Accord (fludarabine phosphate), Genoxal (cyclophosphamide monohydrate), and RoActemra (tocilizumab). These medications are also given through intravenous infusion and are used to help manage the cancer or support the immune system. The study will continue until the end of 2025, with participants being monitored throughout the process to gather important data on the treatment’s effectiveness and safety.

1 initial treatment phase

The initial phase involves the administration of several medications through intravenous infusion. These medications include bendamustine hydrochloride, fludarabine phosphate, and cyclophosphamide monohydrate. The purpose of these medications is to prepare the body for the main treatment.

The specific dosages and frequency of these medications will be determined by the medical team based on individual patient needs and responses.

2 main treatment phase

The main treatment involves the administration of HSP-CAR30 cells. These are specially modified cells designed to target and attack cancer cells. The administration is done through intravenous infusion.

The goal of this phase is to evaluate the safety and effectiveness of the HSP-CAR30 cells in treating the specific type of lymphoma.

3 monitoring and follow-up

After the infusion of HSP-CAR30 cells, there is a monitoring period of 30 days. During this time, the medical team will closely observe for any side effects or adverse reactions.

Regular assessments will be conducted to evaluate the response to the treatment, using imaging techniques such as PET-CT scans to measure the disease’s status.

4 safety and response evaluation

The primary focus during this phase is to assess the safety and toxicity of the treatment. This includes calculating the proportion of patients experiencing dose-limiting toxicity within the first month after the infusion.

The response to the treatment will be analyzed according to specific criteria, and only patients who receive the infusion will be evaluated for response.

Who Can Join the Study?

All patients must sign an informed consent form before starting any procedure. This means you agree to participate after understanding the study details.
General health status should be good, as measured by the ECOG scale, which should be 0 or 1. This scale checks how well you can perform daily activities.
Breathing tests should show FEV1, DLCO, and FVC values greater than 39% of normal. These tests measure lung function.
The heart should be working well, with a left ventricular ejection fraction greater than 45%. This measures how well your heart pumps blood.
Liver function tests should show total bilirubin and transaminases less than 3 times the normal maximum value, unless the lymphoma causes higher levels.
Kidney function should be good, with creatinine less than 2 times the normal maximum value and clearance greater than 40 mL/min. These tests check how well your kidneys are working.
Tests for HIV, HBV, and HCV should be negative. If positive for HBV or HCV, the viral load must be 0, meaning no active virus is present.
No active, significant bacterial or viral infections should be present. Tests for flu, respiratory syncytial virus, and SarsCov2 must be negative before starting treatment.
The disease must be measurable using a PET-CT scan at the time of joining the study. This scan helps see the size and location of the disease.
For patients with classic Hodgkin’s disease:
- Age should be between 18 and 80 years or older.
- Patients should have relapsed after an autologous transplant of blood-forming cells and previously received specific treatments (brentuximab vedotin and anti-PDL1 antibodies) without achieving complete remission (CR).
- Primary refractory patients, meaning those who did not respond to the first treatment, should not achieve CR after rescue treatments that include brentuximab and anti-PDL1 antibodies.
For patients with anaplastic large cell T lymphoma and peripheral T lymphoma:
- CD30 expression should be present in more than 90% of tumor cells, determined by a test called immunohistochemistry.
- Age should be 18 years or older.
- Patients should have relapsed after an autologous transplant of blood-forming cells.
- Primary refractory patients, meaning those who did not respond to the first treatment that includes anthracycline, should not achieve CR after rescue chemotherapy (types like ESHAP, ICE, DHAP, Gemox, or brentuximab vedotin).

Who Cannot Join the Study?

Patients with other types of cancer that are not Hodgkin T CD30+ lymphoma or non-Hodgkin T CD30+ lymphoma cannot participate. Lymphoma is a type of cancer that starts in the cells of the immune system.
Patients who are not experiencing a relapse or refractory condition of the specified lymphomas cannot participate. Relapse means the cancer has returned after treatment, and refractory means the cancer does not respond to treatment.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to be within the required age group.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
Patients who do not meet the safety and health requirements for the study cannot participate. This includes any health conditions that might make participation unsafe.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hfrgzmsm Dz Lo Sgmmy Cwma I Siwa Pxt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.10.2019

Trial locations

Investigated drugs:

HSP-CAR30 is a type of immunotherapy that uses a patient’s own T cells. These T cells are taken from the patient’s blood and then modified in the lab. The modification involves using a lentiviral vector to introduce a new gene into the T cells. This gene helps the T cells to produce a special receptor called an anti-CD30-chimeric antigen receptor. This receptor allows the T cells to better recognize and attack cancer cells that have the CD30 marker, which is common in certain types of lymphoma, such as Classical Hodgkin lymphoma and non-Hodgkin CD30+ T cell lymphoma. The goal of this therapy is to improve the body’s ability to fight these cancers.

Investigated diseases:

Refractory or Relapsed Hodgkin T CD30+ Lymphoma – This is a type of cancer that affects the lymphatic system, specifically involving T-cells that express the CD30 protein. It is characterized by the persistence or return of the disease after initial treatment. The disease typically involves the enlargement of lymph nodes and can spread to other parts of the body. Patients may experience symptoms such as fatigue, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases remaining localized while others become more widespread.

Refractory or Relapsed Non-Hodgkin T CD30+ Lymphoma – This is a cancer of the lymphatic system that involves T-cells with CD30 protein expression, which does not respond to initial treatment or returns after treatment. It can manifest with swollen lymph nodes, fever, night sweats, and unintended weight loss. The disease can progress by spreading to other organs and tissues beyond the lymph nodes. The course of the disease can differ among individuals, with some experiencing slow progression and others facing more rapid advancement. Symptoms and disease progression can impact daily life and overall health.

Trial ID:

2024-515624-36-00

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety of HSP-CAR30 Immunotherapy for Patients with Relapsed or Refractory CD30+ Hodgkin and Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?