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Study on the Safety and Effectiveness of ALLO-501A and ALLO-647 for Adults with Relapsed or Refractory Large B-Cell Lymphoma

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 a type of cancer called Large B-Cell Lymphoma (LBCL), which is a form of blood cancer that affects a type of white blood cell known as B cells. The study is testing a new treatment called ALLO-501A, which is a type of therapy that uses specially modified cells to target and destroy cancer cells. This treatment is combined with another medication called ALLO-647, which is a monoclonal antibody designed to help the body accept the cell therapy. The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients whose cancer has returned or has not responded to previous treatments.

Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into the bloodstream. The study will monitor how the body responds to the treatment over a period of time, looking at factors such as how well the cancer responds and any side effects that may occur. The study will also explore how the treatment affects the immune system and how long the modified cells remain active in the body.

This trial is an important step in understanding how these new therapies can help people with Large B-Cell Lymphoma who have limited treatment options. By participating, researchers hope to gather valuable information that could lead to new and effective treatments for this type of cancer in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and current health status.

    A diagnosis of relapsed/refractory large B-cell lymphoma must be confirmed, and certain health criteria must be met, such as adequate liver and kidney function.

  2. Step 2

    Pre-treatment phase

    Before starting the main treatment, you will receive medications to prepare your body. This includes fludarabine phosphate and cyclophosphamide, both administered through an intravenous infusion.

    These medications help to prepare your immune system for the main treatment by reducing the number of certain blood cells.

  3. Step 3

    Main treatment

    The main treatment involves the administration of ALLO-501A, an anti-CD19 allogeneic CAR T cell therapy, through an intravenous infusion.

    You will also receive ALLO-647, an anti-CD52 monoclonal antibody, to support the main treatment.

  4. Step 4

    Supportive care

    During the treatment, supportive care medications will be provided to manage side effects. These include promethazine hydrochloride for nausea, hydrocortisone for inflammation, and paracetamol for pain relief.

    Other medications like loratadine and famotidine may be used to manage allergic reactions and stomach acid, respectively.

  5. Step 5

    Follow-up and monitoring

    After the main treatment, regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment.

    These visits will include physical exams, blood tests, and imaging studies to assess the response to the treatment and to check for any side effects.

Who can join the trial?

10 criteria

  • Must have a confirmed diagnosis of relapsed/refractory large B-cell lymphoma (LBCL) at the last relapse, according to the World Health Organization (WHO) 2017 guidelines.
  • Must have at least one measurable tumor at the time of joining the study.
  • The disease must have returned or not responded after at least two different chemotherapy treatments.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means the patient is fully active or has some symptoms but does not need bed rest during the day.
  • Must not have significant donor-specific anti-HLA antibodies at screening. These are antibodies that might react against the treatment.
  • Must have adequate blood cell counts and function.
  • Must have adequate kidney function.
  • Must have adequate liver function.
  • Both males and females can participate.
  • Participants can be from vulnerable populations, which may include groups like children or the elderly.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer besides Large B-Cell Lymphoma (LBCL) cannot participate.
  • Patients who have not experienced a return or worsening of their LBCL after treatment cannot participate. This is referred to as R/R LBCL, meaning "relapsed or refractory" LBCL.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not able to give informed consent or understand the study requirements cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with certain medical conditions that might interfere with the study treatment cannot participate. These conditions are usually specified by the study organizers.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have had certain treatments or medications that might interfere with the study cannot participate.
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Investigated drugs

  • ALLO-501A

    is a type of therapy that uses specially modified cells to help fight cancer. These cells are called CAR T cells, and they are designed to target and destroy cancer cells in the body. In this trial, ALLO-501A is being tested to see how well it works in treating a type of cancer called Large B Cell Lymphoma, which has come back or has not responded to previous treatments. The goal is to see if these modified cells can help reduce the cancer or make it go away.

  • ALLO-647

    is a medication that helps prepare the body to receive the ALLO-501A therapy. It is a type of drug known as a monoclonal antibody, which means it is designed to target specific cells in the body. ALLO-647 works by targeting certain immune cells, helping to create a better environment for the ALLO-501A therapy to work effectively. This preparation is important to increase the chances of success for the main treatment.

What is already known about the treatment

  • ALLO-501A

    ALLO-501A is administered as an infusion, which means it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating a type of cancer called Large B-Cell Lymphoma (LBCL), particularly in patients whose cancer has returned or not responded to previous treatments. The main therapeutic goal of ALLO-501A is to help the immune system recognize and attack cancer cells. It works by using specially modified immune cells, known as CAR T cells, that are designed to target a specific protein on the surface of cancer cells. ALLO-501A is classified as a type of cell therapy, which is a form of treatment that uses living cells to fight disease.

  • ALLO-647

    ALLO-647 is given as an infusion, meaning it is introduced into the body through a vein. It is being investigated in clinical trials for its role in treating Large B-Cell Lymphoma (LBCL) when the disease has returned or not responded to other treatments. The primary purpose of ALLO-647 is to prepare the body for receiving CAR T cell therapy by reducing the number of certain immune cells that might interfere with the treatment. It functions by targeting a specific protein on these immune cells, helping to create a more favorable environment for the CAR T cells to work effectively. ALLO-647 is classified as a monoclonal antibody, which is a type of drug designed to bind to specific proteins in the body.

Investigated diseases

Large B-Cell Lymphoma (LBCL) – Large B-Cell Lymphoma is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It typically presents as a rapidly growing mass, often in the lymph nodes, spleen, liver, or other organs. The disease progresses as the abnormal B cells multiply uncontrollably, forming tumors that can disrupt normal organ function. As the lymphoma advances, it may spread to other parts of the body, including the bone marrow and central nervous system. Symptoms can include swelling of lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501927-25-00Protocol codeALLO-501A-201Estimated enrolment100 patientsSponsorAllogene Therapeutics Inc.

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