Study on the Safety and Effectiveness of OC-1 Therapy for Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or Lymphoma

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a new treatment called hCD1a-CAR T (also known as OC-1) for patients with a type of blood cancer known as T-cell Acute Lymphoblastic Leukemia or T-cell Acute Lymphoblastic Lymphoma. These are aggressive forms of cancer that affect the white blood cells, and the study is specifically for patients whose cancer has returned or has not responded to previous treatments. The treatment involves using the patient’s own immune cells, which are modified outside the body to better recognize and attack cancer cells when reintroduced into the bloodstream.

The purpose of the study is to assess the safety of this new treatment in patients with relapsed or refractory CD1a-positive T-cell cancers. Participants in the study will receive the hCD1a-CAR T therapy through an intravenous infusion, which means the treatment is delivered directly into the bloodstream. The study will monitor patients for any side effects and evaluate how well the treatment works in controlling the cancer. Some patients may receive a placebo as part of the study to compare the effects of the new treatment.

Throughout the study, patients will have regular check-ups to assess their health and the response of their cancer to the treatment. The study aims to gather information on the remission rates, which is the period during which the cancer is under control, and overall survival, which is the length of time patients live after receiving the treatment. The study will also look at how long the modified immune cells remain active in the body. This research is important for developing new therapies for patients with these challenging types of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of CD1a antigen in at least 20% of cells, either through flow cytometry or histological confirmation.

Eligibility criteria include being a child older than 2 years or an adult, having relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoma, and meeting specific medical conditions related to previous treatments.

2 t-cell collection

T-cells are collected from the patient. These cells are then modified outside the body using a lentiviral vector to encode a chimeric antigen receptor (CAR) specific for CD1a.

3 cell modification

The collected T-cells are modified in a laboratory setting to create the hCD1a-CAR T cells. This process involves genetic modification to enhance the cells’ ability to target and destroy cancer cells.

4 infusion preparation

Before the infusion of the modified T-cells, the patient may undergo a conditioning regimen to prepare the body for the treatment. This step is crucial for the success of the infusion.

5 hCD1a-CAR T cell infusion

The modified T-cells, now called hCD1a-CAR T cells, are administered to the patient through an intravenous infusion. This is the main treatment phase where the cells are expected to target and eliminate cancer cells.

6 monitoring and follow-up

After the infusion, the patient is closely monitored for any adverse effects and the effectiveness of the treatment. Monitoring includes assessing the number of adverse events, the incidence of severe reactions, and the overall response to the treatment.

Regular follow-up visits are scheduled to evaluate the patient’s remission status, progression-free survival, and overall survival. The persistence of the modified T-cells is also assessed using specific laboratory techniques.

Who Can Join the Study?

Children older than 2 years or adults, both males and females, can participate.
Patients must have a specific marker called CD1a antigen present in at least 20% of their cancer cells. This can be confirmed through special tests like flow cytometry or by examining tissue samples.
Patients with relapsed/refractory CD1a-positive T-ALL/LL can join. This includes those who have had a return of cancer in the bone marrow or other areas after two treatment attempts, or those who did not respond to initial treatments. Specific situations include:
- Relapse after a type of stem cell transplant called allogeneic haematopoietic stem cell transplantation (allo-HSCT).
- Primary refractoriness, meaning the cancer did not go away after two standard treatments, making the patient not suitable for allo-HSCT.
- Refractory first relapse, meaning the cancer returned and did not respond to treatment.
- Second or further relapse, meaning the cancer has returned multiple times.
Patients must either be unable to have children or agree to use a highly effective method of birth control during the study.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied.
Patients who are not in the age range specified for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.
Patients who are unable to provide consent to participate in the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	31.01.2023

Trial locations

Investigated drugs:

Autologous T-Cells Ex Vivo Modified With A Lentiviral Vector Encoding A Chimeric Antigen Receptor Specific For Cd1A

hCD1a-CAR T (OC-1): This is a type of therapy that uses specially modified immune cells called T-cells to target and attack cancer cells. In this trial, the T-cells are engineered to recognize a specific marker, CD1a, found on certain cancer cells in patients with T-cell acute lymphoblastic leukemia or lymphoma. The goal is to help the immune system better identify and destroy these cancer cells, especially in cases where the disease has returned or not responded to previous treatments.

T-cell Acute Lymphoblastic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells known as lymphoblasts. It primarily involves T-cells, a type of white blood cell that plays a crucial role in the immune system. The disease progresses rapidly, leading to an accumulation of these abnormal cells in the bone marrow, which can interfere with the production of normal blood cells. Patients may experience symptoms such as fatigue, fever, and easy bruising or bleeding due to the lack of healthy blood cells. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen.

T-cell Acute Lymphoblastic Lymphoma – This is a type of non-Hodgkin lymphoma that originates from T-cells, a subset of white blood cells. It is closely related to T-cell acute lymphoblastic leukemia but primarily presents as a mass in the lymphoid tissues, such as the thymus or lymph nodes. The disease progresses quickly, with the potential to spread to other organs, including the bone marrow and central nervous system. Symptoms may include swollen lymph nodes, chest pain, and difficulty breathing if the thymus is involved. As the abnormal T-cells multiply, they can disrupt normal immune function and lead to systemic symptoms like fever and weight loss.

Trial ID:

2024-514591-40-00

Protocol code:

OC-01-21001- CARxALL

NCT ID:

NCT05679895

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study on the Safety and Effectiveness of OC-1 Therapy for Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or Lymphoma

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