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Study of CART84 Treatment for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia and T-Cell Acute Lymphoblastic Leukemia

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating patients with Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia (T-ALL) that have not responded to previous treatments or have returned after treatment. The study will test a new treatment called CART84, which is made from a patient's own immune cells that are modified in a laboratory to better fight cancer cells.

The purpose of this research is to determine if CART84 is safe to use and to find the most effective dose for treating these types of blood cancers. The treatment involves collecting immune cells from the patient, modifying them to target cancer cells, and then returning them to the patient through an intravascular infusion (delivery into a vein).

During the study, patients will receive the CART84 treatment and will be monitored for response to therapy and any side effects. After receiving CART84, some patients may proceed to receive a stem cell transplant from a matched donor. The study includes regular blood tests and bone marrow examinations to check how well the treatment is working.

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 medical assessment

    Your blood and bone marrow will be tested to confirm at least 5% of leukemia cells are present

    Medical tests will check your kidney, liver, lung, and heart function

    Your blood oxygen level must be above 92% when breathing room air

    Your physical condition will be evaluated using the ECOG scale, which measures your ability to perform daily activities

  2. Step 2

    Pre-treatment preparation

    A stem cell donor will be identified for possible future transplant

    The donor can be a family member or unrelated person with matching tissue type

    This transplant may occur between 30-90 days after your CART84 treatment

  3. Step 3

    CART84 treatment

    You will receive CART84 cells through an intravenous infusion

    The treatment is given as a dispersion (liquid form) into your bloodstream

    Your response to the treatment will be monitored closely for the first 30 days

  4. Step 4

    Post-treatment monitoring

    Regular blood tests will track your recovery and the presence of CART84 cells

    Bone marrow tests will check for remaining cancer cells

    Your blood cell counts will be monitored to ensure proper recovery

    You will be checked for possible side effects for up to 6 months

  5. Step 5

    Long-term follow-up

    Your progress will be monitored for up to 24 months

    Regular checkups will assess your overall health and cancer status

    If needed, you may proceed to stem cell transplant between 30-90 days after CART84 treatment

Who can join the trial?

11 criteria

  • Must be 18 years or older at the time of signing the consent
  • Male participants must use 2 methods of contraception (one barrier method by the patient and one highly effective method by their partner) during treatment and for 12 months after the last dose
  • Must have adequate organ function including: - Normal or slightly elevated liver function tests - Good kidney function - Normal bilirubin levels (except for patients with Gilbert's syndrome) - Heart pumping function of at least 45% - Blood oxygen levels above 92% when breathing room air
  • Must be willing and able to provide written informed consent
  • Must have good physical function status (ECOG score of 0 or 1, meaning able to carry out light work)
  • Must have diagnosed blood cancer (AML or T-ALL) with at least 5% cancer cells in bone marrow or blood, and either: - Disease that didn't respond to initial treatment - Second or later relapse - Disease that returned and didn't respond to salvage therapy - Disease that returned after stem cell transplant (at least 3 months must have passed)
  • Must have confirmed CD84 protein present on cancer cells
  • For T-ALL patients: must have specific type of T-ALL (either lacking CD4 and CD8 markers, or having these markers but no cancer cells in blood)
  • Must have an available stem cell donor (family member or unrelated) for possible transplant 30-90 days after treatment
  • Women who can become pregnant must have a negative pregnancy test before starting treatment
  • Women who are not post-menopausal or surgically sterile must use 2 methods of contraception (one highly effective method plus a barrier method) during treatment and for 12 months after the last dose

Who cannot join the trial?

14 criteria

  • Active or uncontrolled infection, including patients with hepatitis B, hepatitis C, or HIV (human immunodeficiency virus)
  • History of other cancers in the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Pregnant or breastfeeding women
  • Severe heart problems, including uncontrolled heart failure or serious heart rhythm disorders
  • Severe lung problems that require oxygen therapy
  • Severe kidney problems requiring dialysis
  • Severe liver problems
  • Active disease in the central nervous system (brain and spinal cord)
  • Previous treatment with CAR-T cell therapy
  • Participation in another clinical trial within 30 days before starting this study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to provide informed consent
  • Known allergic reactions to components of the study treatment
  • Psychiatric conditions that could interfere with study participation
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Investigated drugs

CART84 is a type of cell therapy where a patient's own immune cells (T-cells) are modified in a laboratory to recognize and fight cancer cells. This therapy is specifically designed to target cells in acute myeloid leukemia (AML) and acute lymphoblastic T leukemia (T-ALL). The modified T-cells are given back to the patient through an infusion to help their immune system fight the cancer.

What is already known about the treatment

CART84 - A novel cell therapy product administered through intravenous infusion, consisting of genetically modified T cells designed to target specific antigens present on leukemia cells. This investigational treatment is currently being evaluated in Phase I/IIa clinical trials for patients with relapsed or refractory acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL). CART84 belongs to the class of CAR-T cell therapies, where the patient's own immune cells are engineered to recognize and attack cancer cells, representing a personalized approach to cancer treatment. The therapy works by enabling modified T cells to identify and eliminate cancer cells that have become resistant to conventional treatments, offering a potential new option for patients who have exhausted other therapeutic alternatives.

Investigated diseases

  • Acute Lymphoblastic T Leukemia (T-ALL)

    A blood cancer that develops when abnormal T lymphocytes (a type of white blood cell) begin multiplying uncontrollably in the bone marrow. These abnormal cells crowd out healthy blood cells and can spread to other parts of the body. The disease progresses rapidly without intervention, affecting the body's ability to fight infections and maintain normal blood functions. This condition primarily affects the blood and bone marrow, causing symptoms such as fatigue, frequent infections, and easy bruising.

  • Acute Myeloid Leukemia (AML)

    A type of blood and bone marrow cancer where the body produces abnormal myeloid cells, which are precursors to various types of blood cells. These immature cells accumulate in the bone marrow and interfere with the production of normal blood cells. The disease develops quickly, with abnormal cells rapidly replacing healthy blood-forming cells. As the condition progresses, it affects the body's ability to produce normal white blood cells, red blood cells, and platelets.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-519966-31-00Protocol codeGYA-CART84-AL-001Estimated enrolment39 patientsSponsorGyala Therapeutics S.L.

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