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Study of cc-97540 CD19‑Targeted NEX‑T CAR T in participants with chronic immune thrombocytopenia and autoimmune hemolytic anemia

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study focuses on two blood‑cell disorders: Chronic Immune Thrombocytopenia (cITP), in which the body destroys platelets that help stop bleeding, and Autoimmune Hemolytic Anemia (AIHA), where the immune system attacks red blood cells, leading to anemia. The investigational therapy is a specially engineered cell product called Zolacabtagene Autoleucel (BMS-986353), also known as Zola‑cel, which belongs to a class of treatments named CD19-Targeted NEX‑T CAR T Cells. These cells are made from a patient’s own immune cells, altered in the laboratory, and then given back through an intravenous (through the vein) infusion; the active ingredient is identified by the code cc-97540. The main goal of the trial is to see whether this therapy is safe, tolerable, and effective in improving blood counts for people with these conditions.

Participants will first undergo screening tests, then receive a single infusion of the modified cells. After the infusion, they will have regular clinic visits where blood samples are drawn and simple health questionnaires are completed to monitor for any side effects and to check if platelet or red‑cell numbers improve. Follow‑up continues for several months to observe how long any benefit lasts and to record any additional medical support needed. Throughout the study, doctors will watch for any unusual lab results or symptoms and will provide standard medical care as needed.

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

    Enrollment and consent

    After joining the study, you will read information about the trial and sign a consent form that explains what will happen and any possible risks.

  2. Step 2

    Baseline evaluations

    The study team will collect your medical history, perform a physical exam, and draw blood samples to assess your current condition and to establish baseline values for later comparison.

  3. Step 3

    Administration of <b>zola-cel</b> (<b>cd19‑targeted nex‑t car t</b>)

    You will receive a single infusion of the investigational cell therapy.

    The product is a cell suspension for injection that is given intravenously (through a vein).

    The prescribed dose is 9999 units; this amount is administered only once during the trial.

  4. Step 4

    Immediate post‑infusion monitoring

    After the infusion, you will stay in the clinic for several hours while staff check your vital signs and watch for any early side effects.

    Blood tests may be repeated during this period to look for immediate changes.

  5. Step 5

    Ongoing follow‑up visits

    You will return for scheduled visits that include physical examinations, symptom checks, and regular blood tests to evaluate safety and efficacy of the treatment.

    These visits continue for the remainder of the study period, allowing the team to monitor how the therapy affects your condition and to record any side effects that appear later.

Who can join the trial?

5 criteria

  • Be diagnosed with chronic immune thrombocytopenia (cITP) – a long‑lasting condition with very low platelet numbers – or autoimmune hemolytic anemia (AIHA) – a condition where the immune system destroys red blood cells.
  • Be at least 18 years old.
  • Have tried at least two prior treatments that either did not work for you or caused side effects that made you stop using them.
  • If you have cITP, your platelet count (the number of platelets in your blood) must be less than 30 × 10⁹/L, or less than 50 × 10⁹/L if you are taking medicines called TPO‑RA (drugs that help your body make more platelets).
  • If you have AIHA, your doctor must have documented hemolysis (the breaking down of red blood cells) and your hemoglobin level (the protein that carries oxygen in red blood cells) must be under 10 g/dL without a recent red blood cell transfusion, or you must require regular transfusions.

Who cannot join the trial?

7 criteria

  • Having Evans syndrome, which is a combination of low platelets and anemia caused by the immune system.
  • Having another autoimmune disease that affects the whole body or a single organ and requires medicines called immunosuppressants (drugs that lower the activity of the immune system).
  • Having a viral infection such as hepatitis C or HIV that can affect blood cells.
  • Having a reaction caused by certain medicines or vaccines that leads to low platelets or anemia.
  • Having had a major surgical procedure recently.
  • Having a blood‑related cancer (called a hematologic malignancy), such as leukemia or lymphoma.
  • Having any other type of cancer that was diagnosed within the past 2 years.
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Investigated drugs

  • Zolacabtagene Autoleucel (zola‑cel)

    is a personalized cell therapy in which a patient’s own immune cells are taken out, genetically changed in the lab, and then put back into the body. The modified cells are designed to recognize and reduce the abnormal immune activity that causes chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA). In this study the therapy is being given to see if it is safe, tolerable, and effective at improving platelet counts and reducing red‑blood‑cell destruction.

  • CD19‑Targeted NEX‑T CAR T (CC‑97540)

    is another type of CAR T cell therapy that targets the CD19 protein found on certain immune cells. Like zola‑cel, the patient’s cells are collected, engineered to attack CD19‑positive cells, and infused back into the patient. The trial includes this therapy to evaluate its safety and how well it works for people with cITP and AIHA, either alone or in combination with other treatments.

What is already known about the treatment

CD19-Targeted NEX-T CAR T - It is given as an intravenous infusion of a suspension of specially modified immune cells that are injected directly into the bloodstream. The product is still experimental and is currently being evaluated in phase‑2 clinical trials, so it is not yet approved for general medical use. It is being studied as a treatment for chronic immune thrombocytopenia and autoimmune hemolytic anemia. The therapy works by re‑programming the patient’s own T‑cells to recognize the CD19 marker on B‑cells, leading to removal of those B‑cells that drive the disease, and it belongs to the class of CAR‑T cell (cellular immunotherapy) medicines.

Investigated diseases

  • Chronic immune thrombocytopenia (ITP)

    It is a disorder in which the immune system mistakenly attacks platelets, leading to a persistently low platelet count. Over time the low count remains, making bruises, nosebleeds, and small skin spots appear easily. The body continues to destroy newly produced platelets, so the shortage can last for months or years. Symptoms may become more noticeable during infections, stress, or after vaccinations. The condition often shows periods of relative stability followed by episodes of increased bleeding tendency.

  • Autoimmune hemolytic anemia (AIHA)

    This disease occurs when the immune system targets and destroys red blood cells, resulting in anemia. The ongoing loss of red cells reduces the blood’s ability to carry oxygen, causing fatigue and shortness of breath. Hemolysis can be continuous, with the body constantly breaking down red cells faster than they are made. Anemia may gradually worsen, especially during infections, stress, or other immune challenges. The disease frequently follows a pattern of fluctuating severity, with partial improvement and later relapse.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524993-41-00Protocol codeCA0611040Estimated enrolment8 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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