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Study on CCTx-001, Cyclophosphamide Monohydrate, and Fludarabine Phosphate for Patients with Relapsed or Refractory Acute Myeloid Leukemia

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 blood cancer called Acute Myeloid Leukemia (AML), specifically in patients whose disease has returned or has not responded to previous treatments. The trial will test a new treatment called CCTx-001, which is a form of cell therapy known as Chimeric Antigen Receptor T Cells (CAR-T). These are special immune cells that have been modified to better recognize and attack cancer cells. The study will also use two other medications, Cyclophosphamide Monohydrate and Fludarabine Phosphate, which are given to help prepare the body for the CAR-T cell treatment.

The purpose of the study is to find the best dose of CCTx-001 and to see how safe and effective it is for patients with relapsed or refractory AML. The study will be conducted in two phases. In the first phase, the focus will be on determining the safest dose and understanding any side effects. In the second phase, the study will look at how well the treatment works in controlling the leukemia. Patients will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, participants will be closely monitored for any side effects and to see how their leukemia responds to the treatment. The study aims to gather important information that could lead to new treatment options for people with this challenging form of leukemia. Participants will receive regular check-ups and assessments to track their health and the progress of their treatment.

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

    Initial assessment

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

    A blood test is performed to ensure a circulating blast count of less than 20,000/mm³. Additional tests may be conducted to assess organ function and overall health.

  2. Step 2

    Leukapheresis preparation

    Eligible patients undergo a procedure called leukapheresis, which involves collecting white blood cells from the blood. This is necessary for the preparation of the treatment.

  3. Step 3

    Treatment phase 1

    The first phase of treatment involves the administration of cyclophosphamide monohydrate and fludarabine phosphate through intravenous infusion. This is done to prepare the body for the main treatment.

    The dosage and frequency of these medications are determined by the medical team based on individual patient needs.

  4. Step 4

    Administration of cctx-001

    Following the initial treatment, the main medication, CCTx-001, is administered. This is also given through intravenous infusion.

    The goal of this phase is to evaluate the safety and tolerability of CCTx-001, as well as to determine the appropriate dosage for further treatment.

  5. Step 5

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the patient's response to the treatment. This includes tracking any side effects and evaluating the effectiveness of the medication.

    The medical team will perform regular check-ups and tests to ensure the patient's safety and to adjust treatment as necessary.

  6. Step 6

    Treatment phase 2

    In the second phase, the focus shifts to evaluating the clinical activity of CCTx-001. This involves assessing the patient's response to the treatment and determining the overall effectiveness.

    The treatment continues with adjustments made based on the patient's progress and any side effects experienced.

  7. Step 7

    Completion and follow-up

    Upon completion of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

    Follow-up appointments may be scheduled to monitor the patient's health and to gather additional data for the study.

Who can join the trial?

11 criteria

  • Patients must have active **relapsed/refractory acute myeloid leukemia (AML)**, which means the disease has returned or did not respond to treatment.
  • Women who can have children must have a negative pregnancy test.
  • Patients who can have children must agree to use a highly effective birth control method during the study and for 12 months after the last dose of the study drug.
  • Patients must have a **circulating blast count** (a type of white blood cell) of less than 20,000 per cubic millimeter. This can be controlled with a medication called hydroxyurea.
  • Patients must have an **absolute lymphocyte count** (a type of white blood cell) of more than 200 per cubic millimeter.
  • Patients must have an **Eastern Cooperative Oncology Group performance status** of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • Patients must have a life expectancy of more than 3 months.
  • Patients must be 18 years or older at the time they agree to participate in the study.
  • Patients must read, understand, and sign a written informed consent form before any study procedures begin.
  • Patients must be eligible for **leukapheresis**, a procedure to collect white blood cells.
  • Patients must have adequate organ function, meaning their organs are working well enough to participate in the study.
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Investigated drugs

CCTx-001 is an investigational medication being studied for its potential use in treating patients with relapsed or refractory acute myeloid leukemia. The trial aims to determine the appropriate dose for future studies and to assess how safe and tolerable the medication is for patients. Additionally, the study will evaluate how effective CCTx-001 is in achieving a complete response in patients.

What is already known about the treatment

CCTx-001 – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating relapsed or refractory acute myeloid leukemia (AML). It is in the early stages of research, specifically in a phase 1/2 trial, to determine its safety, tolerability, and effectiveness. The main therapeutic indication for CCTx-001 is to help patients with AML who have not responded to previous treatments. At the molecular level, it works by targeting specific pathways involved in the growth and survival of cancer cells, aiming to inhibit their proliferation. CCTx-001 is classified as an investigational anti-cancer agent.

Investigated diseases

Relapsed/Refractory Acute Myeloid Leukemia (AML) – This is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These cells accumulate in the bone marrow and interfere with the production of normal blood cells. "Relapsed" refers to the return of the disease after treatment, while "refractory" indicates that the disease does not respond to treatment. The progression of AML can lead to symptoms such as fatigue, fever, and an increased risk of infections and bleeding. The disease can advance quickly, requiring prompt medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-506865-71-00Protocol codeCCTx-001-AML-001Estimated enrolment105 patientsSponsorCanCell Therapeutics

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