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Study on ALLO-647 and ALLO-501A 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. The study is evaluating a new treatment approach for patients whose cancer has returned or has not responded to previous treatments. The treatment being tested involves a combination of medications used to prepare the body for a special type of cell therapy. The medications include Fludarabine and Cyclophosphamide, which are chemotherapy drugs, and ALLO-647, a type of protein-based medication. The cell therapy being used is called ALLO-501A, which is a form of CAR T cell therapy. CAR T cell therapy is a treatment where a patient's T cells, a type of immune cell, are modified to better fight cancer cells.

The purpose of the study is to see how effective the combination of these medications is in helping the body accept the CAR T cell therapy and to compare it to the use of Fludarabine and Cyclophosphamide alone. Participants in the study will receive either the combination of Fludarabine, Cyclophosphamide, and ALLO-647 or just Fludarabine and Cyclophosphamide before receiving the ALLO-501A therapy. The study will monitor how well the cancer responds to the treatment and how long the response lasts. It will also look at the safety of the treatment and any side effects that may occur.

The study will take place over a period of time, with participants receiving treatment and being monitored for their response to the therapy. The goal is to gather information that could help improve treatment options for people with relapsed or refractory Large B-Cell Lymphoma. This research could potentially lead to new ways to treat this type of cancer more effectively in the future.

The research process

The trial runs in 7 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, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and performing necessary tests to ensure you meet the study criteria.

  3. Step 3

    Lymphodepletion treatment

    You will receive a combination of medications to prepare your body for the main treatment. This includes fludarabine phosphate and cyclophosphamide, both administered through an intravenous infusion. The exact dosage and frequency will be determined by the study team.

  4. Step 4

    Additional medication

    Depending on the group you are assigned to, you may also receive ALLO-647 as part of the lymphodepletion regimen. This is also administered intravenously.

  5. Step 5

    Main treatment

    The main treatment involves receiving ALLO-501A allogeneic CAR T cell therapy. This is a specialized treatment designed to target and treat large B-cell lymphoma.

  6. Step 6

    Monitoring and follow-up

    After receiving the main treatment, you will be closely monitored for any side effects or changes in your condition. Regular follow-up visits will be scheduled to assess your response to the treatment and ensure your safety.

  7. Step 7

    End of study participation

    Your participation in the study will conclude after the final follow-up visit. The study team will provide you with information on any further steps or treatments that may be necessary.

Who can join the trial?

9 criteria

  • Must have a confirmed diagnosis of relapsed/refractory large B-cell lymphoma (LBCL) at the last relapse.
  • The disease must have come back 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 you are fully active or have some symptoms but can still carry out light work.
  • No significant donor-specific anti-HLA antibodies at screening. These are proteins that could react against the treatment.
  • Must have adequate hematological function, meaning your blood counts are at a safe level.
  • Must have adequate renal function, meaning your kidneys are working well.
  • Must have adequate liver function, meaning your liver is working well.
  • Open to both male and female participants.
  • Participants must be adults.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer besides Large B-Cell Lymphoma (LBCL) cannot participate.
  • Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
  • Patients with severe heart problems are excluded.
  • Patients with uncontrolled infections cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with a history of severe allergic reactions to similar treatments are excluded.
  • Patients with active hepatitis B or C, or HIV infection, cannot participate.
  • Patients who have had a stem cell transplant in the last 3 months are not eligible.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate are excluded.
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Investigated drugs

  • Fludarabine

    is a medication used in this clinical trial to help prepare the body for receiving a special type of cell therapy. It works by lowering the number of certain blood cells, which helps the new therapy work better. This process is called lymphodepletion, and it makes space in the body for the new cells to grow and fight the cancer.

  • Cyclophosphamide

    is another medication used in the trial to help prepare the body for the cell therapy. Like Fludarabine, it helps reduce the number of certain blood cells to make room for the new therapy. This helps the new cells to be more effective in treating the cancer.

  • ALLO-647

    is a medication used in the trial as part of the preparation process before the main cell therapy. It is designed to help the body accept the new cells by reducing the immune response. This helps the new therapy work better by allowing the new cells to survive and fight the cancer more effectively.

  • ALLO-501A

    is the main therapy being tested in this trial. It is a type of cell therapy that uses specially modified cells to target and destroy cancer cells. These cells are designed to recognize and attack the cancer cells in the body, helping to treat the lymphoma more effectively. This therapy is given after the body has been prepared with the other medications.

What is already known about the treatment

ALLO-647 – ALLO-647 is administered as part of a pre-treatment regimen for patients with relapsed or refractory Large B-Cell Lymphoma (LBCL) who are receiving ALLO-501A, a type of CAR T cell therapy. This medication is currently being studied in clinical trials to evaluate its effectiveness in improving patient outcomes when used alongside other drugs like Fludarabine and Cyclophosphamide. The main therapeutic indication for ALLO-647 is to help prepare the body to better accept and respond to the CAR T cell therapy. At the molecular level, ALLO-647 works by targeting specific cells in the immune system to create a more favorable environment for the CAR T cells to function. It is classified pharmacologically as an immunosuppressive agent.

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 ID2023-503830-27-00Protocol codeALLO-647-201Estimated enrolment70 patientsSponsorAllogene Therapeutics Inc.

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