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Study of Rapcabtagene Autoleucel and Ibrutinib for Adults with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Other Blood Cancers

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 several types of blood cancers, including Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B-Cell Lymphoma (DLBCL), Acute Lymphoblastic Leukemia (ALL), and High-Risk Large B-Cell Lymphoma (HR LBCL). The main treatment being tested is called Rapcabtagene Autoleucel, also known by its code name YTB323. This treatment involves using a patient's own immune cells, which are modified to better fight cancer. The study also involves other medications, such as Ibrutinib, Tocilizumab, Cytarabine, Fludarabine Phosphate, Etoposide, Bendamustine Hydrochloride, and Cyclophosphamide Monohydrate.

The purpose of the study is to find the best dose of Rapcabtagene Autoleucel and to understand its safety and effectiveness in treating these cancers. The study is divided into two phases. In the first phase, researchers aim to determine the appropriate dose and assess the safety of the treatment, both alone and in combination with Ibrutinib for CLL/SLL. The second phase focuses on evaluating how well the treatment works in reducing or eliminating the cancer. Participants will receive the treatment through an infusion, which is a method of delivering medication directly into the bloodstream.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. The study will also look at how the treatment affects the cancer over time. This research is important for developing new ways to treat these types of blood cancers and could lead to more effective therapies in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and 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 specific conditions such as chronic lymphocytic leukemia, small lymphocytic lymphoma, and others.

  2. Step 2

    Pre-Treatment Preparation

    Before starting treatment, a series of tests and evaluations are performed to establish baseline health metrics.

    These tests may include blood tests, imaging studies, and other diagnostic procedures.

  3. Step 3

    Treatment Phase I

    The primary objective is to identify the recommended dose of rapcabtagene autoleucel and assess its safety.

    Patients with specific conditions receive rapcabtagene autoleucel as a single agent or in combination with ibrutinib.

  4. Step 4

    Treatment Administration

    Medications are administered through intravenous infusion. The specific drugs include tocilizumab, cytarabine, fludarabine phosphate, etoposide, bendamustine hydrochloride, rapcabtagene autoleucel, ibrutinib, and cyclophosphamide monohydrate.

    The frequency and duration of administration depend on the specific treatment protocol and patient response.

  5. Step 5

    Monitoring and Evaluation

    Patients are closely monitored for any side effects or adverse reactions. This includes regular check-ups and laboratory tests.

    The effectiveness of the treatment is evaluated through various measures, including response rates and progression-free survival.

  6. Step 6

    Follow-Up and Long-Term Monitoring

    After the treatment phase, patients continue to be monitored to assess long-term outcomes and any delayed side effects.

    Follow-up visits are scheduled at regular intervals to ensure ongoing health and well-being.

Who can join the trial?

8 criteria

  • Patients must have one of the following conditions: Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), High-Risk large B-Cell lymphoma (HR LBCL), Diffuse large B-Cell lymphoma (DLBCL), or Acute lymphoblastic leukemia (ALL).
  • For 3L+ DLBCL: Patients must have a disease that has come back or not responded after receiving at least two treatments, including specific types of chemotherapy. They must have a measurable disease at the time of joining the study.
  • For ALL: Patients must have a type of ALL that is positive for a marker called CD19 and have a certain amount of disease in the bone marrow. They must meet at least one of the following: have had a stem cell transplant, have had at least two treatments, have a disease that did not respond to initial treatment, have a first relapse within 12 months, or have a specific genetic type of ALL that did not respond to at least two different targeted treatments.
  • For 1L HR LBCL: Patients must be considered high-risk based on certain criteria at diagnosis, such as a specific score called IPI or certain genetic changes.
  • For 1L HR LBCL: Patients must have received two cycles of initial treatment with specific chemotherapy regimens. If they have a certain type of lymphoma, they must have received a specific treatment called DA-EPOCH-R.
  • For 1L HR LBCL: Patients must have a positive result on a specific type of scan called PET after two cycles of initial treatment. Certain scores on this scan determine eligibility.
  • Participants must be adults, as the study includes age ranges for adults only.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

5 criteria

  • Patients with certain types of cancer, such as Chronic lymphocytic leukemia (a type of blood cancer), Small lymphocytic lymphoma (a type of cancer affecting the lymph nodes), High-Risk large B-Cell lymphoma (a fast-growing type of cancer in the lymphatic system), Diffuse large B-Cell lymphoma (another type of fast-growing cancer in the lymphatic system), and Acute lymphoblastic leukemia (a type of cancer of the blood and bone marrow) may not be eligible.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specific clinical trial groups required for the study.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Rapcabtagene autoleucel

    is a type of therapy used in this clinical trial. It is a form of treatment that involves modifying a patient's own immune cells to help them fight cancer. This therapy is being tested to see how safe it is and how well it works in treating different types of blood cancers, such as relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and acute lymphoblastic leukemia (ALL). It is also being studied in combination with another medication for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

  • Ibrutinib

    is a medication used in combination with rapcabtagene autoleucel in this trial. It is a type of drug that helps to stop cancer cells from growing and spreading. In this study, it is being used to see if it can enhance the effects of rapcabtagene autoleucel in treating CLL and SLL.

What is already known about the treatment

Rapcabtagene autoleucel – This medication is administered through an infusion, typically in a clinical setting. It is currently being studied in clinical trials for its effectiveness and safety in treating various types of blood cancers, including chronic lymphocytic leukemia, small lymphocytic lymphoma, high-risk large B-cell lymphoma, diffuse large B-cell lymphoma, and acute lymphoblastic leukemia. The main therapeutic indication is its potential to target and destroy cancerous cells in these conditions. At the molecular level, rapcabtagene autoleucel works by modifying a patient's own immune cells to better recognize and attack cancer cells. It is classified as a type of gene therapy and immunotherapy, specifically a CAR T-cell therapy, which is a promising area of cancer treatment research.

Investigated diseases

  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

    This disease is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal white blood cells. It progresses slowly and can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. Over time, the accumulation of these cells can interfere with normal blood cell production and function.

  • High-Risk Large B-Cell Lymphoma

    This is an aggressive form of non-Hodgkin lymphoma that originates in the B cells, a type of white blood cell. It is considered high-risk due to its rapid growth and potential to spread quickly to other parts of the body. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss.

  • Diffuse Large B-Cell Lymphoma

    This is the most common type of non-Hodgkin lymphoma, characterized by large cancerous B cells in the lymphatic system. It typically presents with rapidly enlarging lymph nodes, often in the neck, armpit, or groin. The disease can progress quickly, affecting other organs and tissues.

  • Acute Lymphoblastic Leukemia

    This is a fast-growing cancer of the blood and bone marrow that affects immature white blood cells called lymphoblasts. It is most common in children but can also occur in adults. The disease progresses rapidly, leading to symptoms such as fatigue, easy bruising, and increased risk of infections due to the lack of healthy blood cells.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-507062-34-00Protocol codeCYTB323A12101Estimated enrolment243 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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