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Study of CD7-CART01, Cyclophosphamide, and Fludarabine Phosphate for Children and Young Adults with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia/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 blood cancer called relapsed/refractory CD7+ T-cell Acute Lymphoblastic Leukemia/Lymphoma, which affects children and young adults. The study is testing a new treatment called CD7-CART01, which involves using specially modified cells to target and fight the cancer. This treatment is being compared to standard treatments, which include medications like Cyclophosphamide and Fludarabine Phosphate. These medications are given as injections or infusions, which means they are delivered directly into the bloodstream.

The purpose of the study is to find out if the new treatment is safe and to determine the best dose to use. The study is divided into two phases. In the first phase, the focus is on ensuring the safety of the treatment and finding the right dose. In the second phase, the study will look at how well the treatment works at the dose found in the first phase. Participants will receive the treatment and be monitored closely by healthcare professionals to see how their bodies respond.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to provide valuable information that could lead to better treatment options for those affected by this type of cancer. The study is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 6 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 is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility is based on specific criteria, such as age between 6 months and 25 years, and a diagnosis of relapsed or refractory CD7+ T-cell acute lymphoblastic leukemia or lymphoma.

  2. Step 2

    Pre-treatment preparation

    Before treatment begins, a process called apheresis is performed to collect T cells from the blood. This requires adequate venous access or catheter placement.

    Collected T cells are modified to express a chimeric antigen receptor (CAR) targeting CD7, creating CD7-CART01 cells.

  3. Step 3

    Conditioning therapy

    Prior to the infusion of CD7-CART01 cells, conditioning therapy is administered. This involves receiving medications to prepare the body for the new cells.

    The medications used are cyclophosphamide and fludarabine phosphate, given as solutions for injection or infusion.

  4. Step 4

    Cd7-cart01 cell infusion

    CD7-CART01 cells are infused intravenously. The dose is determined based on body weight and is adjusted during the study to find the optimal amount.

    The primary goal is to evaluate the safety and establish the recommended dose of these cells.

  5. Step 5

    Monitoring and follow-up

    After the infusion, monitoring occurs to assess safety and response to treatment. This includes regular check-ups and tests to evaluate the effect on the disease.

    The study aims to determine the antitumor effect by assessing the response in bone marrow, blood, and cerebrospinal fluid.

  6. Step 6

    Study completion

    The study is expected to continue until September 2028, with ongoing assessments to ensure the safety and effectiveness of the treatment.

    Participants will be informed of their progress and any significant findings related to their treatment.

Who can join the trial?

7 criteria

  • The patient must have a diagnosis of **CD7 expressing** T-cell Acute Lymphoblastic Leukemia (T-ALL) or Lymphoblastic Lymphoma (LL). This means that more than 98% of the cancer cells show a marker called CD7.
  • The patient must be between **6 months and 25 years** old.
  • The patient must have **adequate venous access** for a procedure called apheresis, or be eligible for a catheter placement. Apheresis is a process where blood is taken from the body, a part of it is removed, and the rest is returned to the body.
  • The patient or their legal guardian must give **voluntary informed consent**. This means they agree to participate after understanding the study details. For patients under 18, their guardian must consent, and patients 12 and older should also agree verbally if possible.
  • The patient must have a **clinical performance status** of at least 60% on the Karnofsky scale (for those over 16) or the Lansky scale (for those under 16). This is a way to measure how well the patient can perform daily activities.
  • The patient must have a **measurable or evaluable disease** at the time of enrollment. This means there should be some evidence of the disease that can be measured or evaluated using tests like flow-cytometry, cytogenetics, or PCR (polymerase chain reaction) analysis.
  • Before starting treatment, the patient must have a potential **allogeneic hematopoietic stem cell donor** available. This means there should be a possible donor for a stem cell transplant, who could be a matched relative, an unrelated match, or a partially matched donor.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer that is not related to T-cell Acute Lymphoblastic Leukemia or Lymphoma.
  • Patients who have not experienced a return or worsening of their T-cell Acute Lymphoblastic Leukemia or Lymphoma after treatment.
  • Patients who are not within the age range specified for the study, which includes children and young adults.
  • Patients who are not able to safely receive the study treatment due to other health conditions.
  • Patients who are pregnant or breastfeeding, as the study treatment may affect the baby.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who have received certain treatments recently that might interfere with the study treatment.
  • Patients who have an active infection that could be worsened by the study treatment.
  • Patients who have a history of severe allergic reactions to similar treatments.
  • Patients who are participating in another clinical trial that could interfere with this study.
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Investigated drugs

CD7-CART01 is a type of therapy that uses specially modified T cells to target and attack cancer cells. In this trial, the T cells are engineered to express a chimeric antigen receptor (CAR) that specifically recognizes the CD7 protein found on the surface of certain cancer cells. This therapy is being tested in pediatric patients and young adults with relapsed or refractory T-cell Acute Lymphoblastic Leukemia or lymphoblastic lymphoma. The goal is to determine the safety and effectiveness of this treatment.

What is already known about the treatment

CD7-CART01 – This medication is administered through infusion and is currently being studied in clinical trials for its safety and effectiveness. It is designed for patients with relapsed or refractory CD7+ T-cell Acute Lymphoblastic Leukemia or Lymphoma. The main therapeutic indication is to treat these specific types of blood cancers. At the molecular level, CD7-CART01 works by using genetically modified T cells that express a chimeric antigen receptor (CAR) targeting the CD7 protein on cancer cells, leading to their destruction. It falls under the pharmacological classification of CAR T-cell therapies, which are a type of immunotherapy.

Investigated diseases

Relapsed/Refractory CD7+ T-cell Acute Lymphoblastic Leukemia/Lymphoma – This disease is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature T-cells, a type of white blood cell. It is termed "relapsed" when the disease returns after treatment and "refractory" when it does not respond to treatment. The disease progresses as these abnormal cells multiply rapidly, crowding out normal cells and leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. In the case of lymphoma, it involves the lymphatic system, where the cancerous T-cells form tumors in lymph nodes or other tissues. The progression can vary, with some cases advancing quickly, while others may develop more slowly. The focus of research is often on understanding how these cells evade normal growth controls and finding ways to target them effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508355-39-00Protocol codeCD7-CAR01Estimated enrolment26 patientsSponsorOspedale Pediatrico Bambino Gesu'

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