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Long-term Follow-up Study for Patients with Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma Treated with OC-1 Cells

Verified siteInvestigationalNo 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 focuses on patients with T-cell acute lymphoblastic leukemia and T-cell acute lymphoblastic lymphoma, which are types of blood cancers. The study involves a treatment called OC-1, which uses a special type of cell therapy. In this treatment, a patient's own T-cells, a type of white blood cell, are modified outside the body using a lentiviral vector. This vector helps the T-cells develop a chimeric antigen receptor (CAR) that specifically targets a protein called CD1a on cancer cells. The modified T-cells, known as hCD1a-CAR T cells, are then infused back into the patient's bloodstream.

The purpose of this study is to monitor patients who have already received the OC-1 cell therapy. The study will follow these patients for up to 15 years to check for any delayed side effects or adverse events. This long-term follow-up is important to ensure the safety of the treatment and to understand any potential risks that may arise over time. The study will look at various outcomes, such as the number of serious side effects, the development of new health issues, and the overall survival of patients after receiving the therapy.

During the study, researchers will also assess how long the OC-1 cells remain in the body and how they affect the patient's health. This includes checking for the presence of the modified T-cells in the blood and evaluating their impact on the patient's immune system. The study aims to provide valuable information about the long-term effects of this innovative treatment for patients with these challenging types of cancer.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, ensure that you have provided signed and dated informed consent. This confirms your understanding and agreement to participate in the study.

    Verify that you have been previously treated with at least one fraction of OC-1 cell investigational product and that you are able to comply with the study requirements.

  2. Step 2

    Treatment monitoring

    The main objective of the study is to monitor for any delayed adverse events over a period of 15 years following the infusion of CAR-T cells. This involves regular check-ups and assessments to ensure your safety and well-being.

    The study will assess the risk of delayed adverse events, which are unexpected medical issues that may occur after the treatment.

  3. Step 3

    Medication and administration

    The treatment involves the use of hCD1a-CAR T, which is a suspension for intravenous infusion. This means the medication is administered directly into your bloodstream through a vein.

    The medication consists of your own T-cells that have been modified outside the body to target specific cancer cells.

  4. Step 4

    Regular assessments

    You will undergo regular assessments to monitor for any new medical conditions or the progression of existing ones. This includes checking for new malignancies, neurological disorders, autoimmune disorders, hematologic disorders, infections, and skin disorders.

    These assessments help in understanding the long-term effects of the treatment and ensuring your health is closely monitored.

  5. Step 5

    Long-term follow-up

    The study will continue to follow your health status for up to 15 years. This long-term follow-up is crucial to gather comprehensive data on the treatment's effects.

    During this period, your overall survival and progression-free survival will be evaluated, along with the persistence of the OC-1 cells in your body.

Who can join the trial?

5 criteria

  • Patients must have been previously treated with at least one fraction of **OC-1 cell** investigational product. OC-1 cells are a type of treatment being studied.
  • The patient or the patient’s legal representative must have provided signed and dated **informed consent**. Informed consent means they understand the study and agree to participate.
  • The patient must be able to comply with the study requirements, meaning they can follow the study procedures and visits.
  • Both **male** and **female** patients can participate.
  • The study includes patients from vulnerable populations, which means it considers those who might need special attention or care.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than T-cell acute lymphoblastic lymphoma or T-cell acute lymphoblastic leukemia cannot participate.
  • Patients who have not experienced a return of their cancer after treatment or whose cancer is not resistant to treatment cannot participate.
  • Patients who are not positive for CD1a (a specific marker found on some cancer cells) cannot participate.
  • Patients who have not received OC-1 cells (a type of treatment involving modified cells) cannot participate.
  • Patients who are not willing to be monitored for 15 years after receiving the treatment cannot participate.
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Investigated drugs

OC-1 cells are a type of treatment used in this clinical trial for patients with a specific kind of blood cancer called T-cell acute lymphoblastic leukemia or lymphoma. These cells are a form of CAR-T cell therapy, which means they are specially modified cells that are designed to find and attack cancer cells in the body. The goal of using OC-1 cells is to help the immune system target and destroy the cancer cells more effectively. In this trial, patients who have already received OC-1 cells are being monitored over a long period to check for any delayed side effects and to see how well the treatment works over time.

What is already known about the treatment

OC-1 cells – OC-1 cells are administered through an infusion, which means they are delivered directly into the bloodstream. Currently, these cells are being studied in clinical trials, particularly for their use in treating certain types of blood cancers, specifically T-cell acute lymphoblastic leukemia and lymphoma. The main purpose of using OC-1 cells is to help patients whose cancer has returned or did not respond to previous treatments. At the molecular level, these cells work by targeting and destroying cancer cells, using a special receptor that recognizes a specific marker on the cancer cells. This type of treatment is part of a broader category known as CAR-T cell therapy, which is a form of immunotherapy that uses the body's own immune system to fight cancer.

Investigated diseases

  • T-cell Acute Lymphoblastic Leukemia

    T-cell Acute Lymphoblastic Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells known as lymphoblasts. These abnormal cells crowd out normal cells, leading to a decrease in healthy blood cells. The disease progresses rapidly, with symptoms such as fatigue, fever, and easy bruising or bleeding due to the lack of normal blood cells. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The accumulation of lymphoblasts can also cause bone pain and swelling in the lymph nodes.

  • T-cell Acute Lymphoblastic Lymphoma

    T-cell Acute Lymphoblastic Lymphoma is a type of non-Hodgkin lymphoma that originates from T-cells, a type of white blood cell. It is characterized by the rapid growth of malignant lymphocytes, which can form tumors in lymphoid tissues such as the lymph nodes, thymus, and spleen. The disease progresses quickly, often presenting with symptoms like swollen lymph nodes, chest pain, and difficulty breathing due to the enlargement of the thymus. As it advances, it can spread to other organs and tissues, including the bone marrow and central nervous system. The accumulation of cancerous cells can lead to systemic symptoms such as fever, night sweats, and weight loss.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516617-20-00Protocol codeOC-01-23002Estimated enrolment20 patientsSponsorOnechain Immunotherapeutics S.L.

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