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Study on the Safety and Effectiveness of BCN-CP01 for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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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 two types of blood cancers: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are conditions where the body produces too many abnormal white blood cells, which can crowd out healthy cells and lead to various health issues. The treatment being tested in this study is called BCN-CP01, which is a type of cell therapy. This therapy involves using a patient's own immune cells, known as T cells, which are modified in a laboratory to better recognize and attack cancer cells. The modified T cells are then infused back into the patient through a process called intravenous infusion.

The purpose of the study is to evaluate the safety and effectiveness of BCN-CP01 in patients whose CLL or SLL has returned or has not responded to previous treatments. The study is divided into two phases. In the first phase, the focus is on determining the safety of BCN-CP01 and observing any initial signs of its effectiveness. In the second phase, the study aims to further assess how well the treatment works in reducing cancer cells in the body. Participants will receive the treatment and be monitored for any side effects and improvements in their condition.

Throughout the study, participants will undergo regular check-ups and tests to track their health and the response of their cancer to the treatment. The study will help researchers understand if BCN-CP01 can be a viable treatment option for patients with relapsed or refractory CLL or SLL, potentially offering a new way to manage these challenging conditions.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure all criteria are met.

  2. Step 2

    Informed consent

    A detailed explanation of the study is provided, and an informed consent form must be signed. This form confirms understanding and agreement to participate in the study.

  3. Step 3

    Contraception agreement

    Participants must agree to use highly effective methods of contraception from the time of signing the informed consent form until at least 6 months after receiving the BCN-CP01 infusion. This is to prevent pregnancy during the study.

  4. Step 4

    Screening tests

    Screening tests are conducted to ensure adequate bone marrow, renal, hepatic, and pulmonary function. Women of childbearing potential must have a negative pregnancy test before starting treatment.

  5. Step 5

    Treatment preparation

    Preparation for treatment involves confirming the diagnosis of CD19+ chronic lymphocytic leukemia or small lymphocytic lymphoma and ensuring the disease is relapsed or refractory after at least two prior lines of therapy.

  6. Step 6

    Treatment administration

    The treatment involves the administration of BCN-CP01 through intravenous infusion. The dosage and frequency are determined based on the phase of the study and individual response.

  7. Step 7

    Monitoring and follow-up

    Regular monitoring is conducted to assess safety and efficacy. This includes checking for any adverse effects and evaluating the response to treatment. Follow-up visits are scheduled as per the study protocol.

  8. Step 8

    End of study participation

    Upon completion of the study, a final assessment is conducted. Participants are informed about the results and any further steps if necessary.

Who can join the trial?

10 criteria

  • Signed informed consent form.
  • Women who can have children and all men must agree to use very effective birth control methods and not donate eggs or sperm from the time they sign the consent form until at least 6 months after receiving the study treatment.
  • Must be at least 18 years old.
  • Confirmed diagnosis of CD19+ CLL (chronic lymphocytic leukemia) or SLL (small lymphocytic leukemia) that needs treatment. A type of disease change called Richter's transformation is allowed.
  • The disease must have returned or not responded after at least two previous treatments. Patients must have tried or been unable to take certain medications like BTK-inhibitors (e.g., ibrutinib, acalabrutinib), BCL2-inhibitors (e.g., venetoclax), or PI3K inhibitors (e.g., idelalisib, duvelisib). Patients with Richter's transformation who did not respond to a BTK-inhibitor can join regardless of previous treatments.
  • The disease must be measurable according to specific guidelines.
  • Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
  • Must have adequate bone marrow function, which includes having enough white blood cells, platelets, and lymphocytes without recent medical support.
  • Must have adequate kidney, liver, and lung function, including specific levels of proteins and enzymes in the blood, and no significant fluid around the lungs. Oxygen levels must be above 92% on room air.
  • Women who can have children must have a negative pregnancy test before starting certain medications in the study.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer than the ones being studied.
  • Patients who have not experienced a return or worsening of their condition after treatment.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have a serious infection that is not controlled.
  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients who have another serious medical condition that could interfere with the study.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have participated in another clinical trial recently.
  • Patients who have received certain treatments recently that could affect the study results.
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Investigated drugs

BCN-CP01 is a type of therapy that uses specially modified cells from your own immune system to fight cancer. In this trial, the therapy is designed to target a specific protein called CD19 found on the surface of certain cancer cells. The process involves taking some of your immune cells, changing them in a lab to better recognize and attack cancer cells, and then putting them back into your body. This approach aims to help your immune system find and destroy cancer cells more effectively, especially in cases where the cancer has come back or hasn't responded to other treatments.

What is already known about the treatment

BCN-CP01 – BCN-CP01 is administered as a form of cell therapy, specifically using anti-CD19 CAR T-cells, which are modified immune cells designed to target and destroy cancer cells. This treatment is currently being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The main therapeutic use of BCN-CP01 is to help patients whose cancer has returned or not responded to previous treatments. At the molecular level, the therapy works by engineering T-cells to recognize and attack cells expressing the CD19 protein, which is commonly found on the surface of certain cancer cells. This medication falls under the pharmacological classification of immunotherapy, specifically CAR T-cell therapy.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia (CLL) is a type of cancer that starts in the bone marrow and affects the blood, specifically targeting a type of white blood cell called lymphocytes. It progresses slowly and often does not cause symptoms in its early stages. Over time, the abnormal lymphocytes accumulate in the blood and bone marrow, crowding out healthy cells and leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. As the disease advances, it can spread to other parts of the body, including the liver and spleen. CLL is characterized by its relapsing and refractory nature, meaning it can return after treatment and may become resistant to therapies. The progression of CLL varies greatly among individuals, with some experiencing a slow course and others a more aggressive form.

  • Small Lymphocytic Leukemia

    Small Lymphocytic Leukemia (SLL) is a type of cancer closely related to Chronic Lymphocytic Leukemia, primarily affecting the lymph nodes rather than the blood and bone marrow. It involves the overproduction of abnormal lymphocytes, which can accumulate in the lymph nodes, causing them to swell. SLL progresses slowly and may not present symptoms initially, but as it advances, it can lead to symptoms such as fatigue, night sweats, and weight loss. The disease can also affect the liver and spleen, leading to their enlargement. SLL is known for its relapsing and refractory nature, meaning it can return after treatment and may become resistant to therapies. The progression of SLL can vary, with some individuals experiencing a slow course and others a more aggressive form.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-501686-47-00Estimated enrolment25 patientsSponsorGalapagos

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