#1 Clinical Trials Search in Europe

Cd19-Car_Lenti_Allo

A groundbreaking clinical trial is underway to evaluate the potential of CD19-CAR_Lenti_ALLO, an innovative allogeneic CAR T-cell therapy, in treating children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). This phase I study aims to assess the safety, determine the optimal dosage, and gather preliminary efficacy data for this cutting-edge treatment approach.

Table of Contents

What is CD19-CAR_Lenti_ALLO?

CD19-CAR_Lenti_ALLO is an innovative treatment being studied for children and young adults with a specific type of blood cancer called B-cell Acute Lymphoblastic Leukemia (B-ALL). This treatment is particularly aimed at patients whose cancer has either come back after treatment (relapsed) or hasn’t responded well to previous treatments (refractory)[1].

How does CD19-CAR_Lenti_ALLO work?

CD19-CAR_Lenti_ALLO is a type of therapy known as CAR T-cell therapy. CAR stands for Chimeric Antigen Receptor. In this treatment, T-cells (a type of immune cell) are taken from a donor and genetically modified to recognize and attack cancer cells that have a specific marker called CD19 on their surface. These modified T-cells are then given to the patient to help fight their cancer[1].

What makes CD19-CAR_Lenti_ALLO unique is that it’s an allogeneic therapy. This means the T-cells come from a donor, not the patient themselves. This can be especially beneficial for patients who are too ill to provide their own cells for treatment[1].

Who is CD19-CAR_Lenti_ALLO for?

This treatment is being studied for:

  • Children and young adults
  • Patients with B-cell Acute Lymphoblastic Leukemia (B-ALL)
  • Patients whose cancer has relapsed (come back) or is refractory (not responding well to other treatments)
  • Patients who have had a stem cell transplant and their cancer has returned
  • Patients who haven’t had a stem cell transplant but have a matched donor available

These criteria ensure that the treatment is tested on patients who may benefit most from this new approach[1].

The Clinical Trial

CD19-CAR_Lenti_ALLO is currently being studied in a Phase I clinical trial. This is an early-stage trial designed to:

  • Evaluate the safety of the treatment
  • Identify the recommended dose
  • Get preliminary evidence of how well it works

The trial is described as “open-label,” which means both the researchers and the patients know which treatment is being given. It’s also a “dose-escalation” study, which means researchers start with a low dose and gradually increase it to find the best balance between effectiveness and side effects[1].

The Treatment Process

The treatment process involves several steps:

  1. Lymphodepletion: Before receiving the CAR T-cells, patients undergo a process called lymphodepletion. This involves receiving two drugs, Fludarabine and Cyclophosphamide, for three days. This step helps prepare the body to receive the new T-cells[1].
  2. CAR T-cell Infusion: On Day 0 (after lymphodepletion), patients receive a single infusion of the CD19-CAR_Lenti_ALLO cells through an IV (intravenous) line[1].
  3. Monitoring: After the infusion, patients are closely monitored for any side effects and to see how well the treatment is working[1].

Safety and Efficacy Measures

The researchers are looking at several factors to determine if the treatment is safe and effective:

  • Safety: They’re watching for any serious side effects, which they call “Dose Limiting Toxicities” or DLTs. These could include severe reactions to the infusion or serious immune system reactions[1].
  • Efficacy: They’re checking to see if the treatment leads to a complete response (CR) or a complete response with incomplete blood count recovery (CRi). They’re also looking at whether the cancer becomes undetectable at a very sensitive level (called MRD negativity)[1].
  • Long-term outcomes: The study will also track how long patients survive after treatment (overall survival)[1].

Potential Side Effects

While CD19-CAR_Lenti_ALLO is a promising treatment, it may have some side effects. The researchers are particularly watching for:

  • Graft-versus-Host Disease (GvHD): This is a condition where the donor cells attack the patient’s healthy cells. The study is monitoring for both acute (short-term) and chronic (long-term) GvHD[1].
  • Infusion reactions: These are reactions that can occur when the CAR T-cells are given[1].
  • Other toxicities: The researchers are watching for any other unexpected side effects[1].

It’s important to note that this is an early-stage trial, and more research is needed to fully understand the benefits and risks of this treatment. Patients considering this or any experimental treatment should discuss it thoroughly with their healthcare team[1].

Aspect Details
Study Type Phase I, open-label, dose-escalation study
Treatment Single IV infusion of CD19-CAR_Lenti_ALLO (allogeneic CD19-directed CAR T-cells)
Patient Groups Two cohorts: A (fully matched donor) and B (haploidentical donor)
Dose Levels Cohort A: DL1 (3.0×10^6 cells/kg), DL2 (5.0×10^6 cells/kg)
Cohort B: DL1 (1×10^6 cells/kg), DL2 (3×10^6 cells/kg)
Primary Outcomes Safety assessment and establishment of Dose Limiting Toxicity (DLT)
Secondary Outcomes GvHD occurrence and severity, overall safety, complete response rates, MRD negativity, overall survival

FAQ

  • What is CD19-CAR_Lenti_ALLO? CD19-CAR_Lenti_ALLO is a type of allogeneic CAR T-cell therapy. It uses genetically modified T-cells from donors to target and fight B-cell acute lymphoblastic leukemia (B-ALL) in patients whose cancer has returned or not responded to previous treatments.
  • Who is eligible for this clinical trial? This trial is designed for children and young adults with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL). Patients may be eligible if their disease has returned after a stem cell transplant or if they have refractory disease and a fully matched donor is available.
  • How is the treatment administered? Patients receive a single intravenous (IV) infusion of CD19-CAR_Lenti_ALLO on Day 0, after undergoing lymphodepletion therapy. The lymphodepletion involves receiving Fludarabine and Cyclophosphamide for three days before the CAR T-cell infusion.
  • What are the main goals of this clinical trial? The primary goals are to evaluate the safety of CD19-CAR_Lenti_ALLO, identify the recommended dose, and gather initial evidence of its effectiveness in treating relapsed or refractory B-ALL in pediatric and young adult patients.
  • What are some potential side effects being monitored? The study is closely monitoring for side effects such as Graft-versus-Host Disease (GvHD), infusion-related reactions, and other toxicities. The researchers are particularly focused on identifying any dose-limiting toxicities to determine the safest and most effective dose for future treatments.

Ongoing Clinical Trials on Cd19-Car_Lenti_Allo

  • Study on CD19-CAR T Cells, Fludarabine, and Cyclophosphamide for Children and Young Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Allogeneic: Refers to cells or tissues that are taken from a genetically different donor of the same species. In this context, it means the CAR T-cells come from a donor, not the patient themselves.
  • CAR T-cell therapy: A type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. In this case, donor T cells are used instead of the patient's own cells.
  • B-cell Acute Lymphoblastic Leukemia (B-ALL): A type of cancer in which the bone marrow makes too many immature lymphocytes (a type of white blood cell). It affects B-cells, which are important in fighting infections.
  • Relapsed/Refractory: Relapsed means the cancer has returned after treatment. Refractory means the cancer has not responded to treatment.
  • Lymphodepletion: A process of reducing the number of lymphocytes in the body, usually through chemotherapy, to prepare the body for CAR T-cell therapy.
  • Graft-versus-Host Disease (GvHD): A condition that might occur after an allogeneic transplant where the donor cells attack the recipient's body.
  • Dose-limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or level of use.
  • Minimal Residual Disease (MRD): Small numbers of cancer cells that remain in the body during or after treatment.
  • Complete Response (CR): The disappearance of all signs of cancer in response to treatment.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients are still alive.

References

  1. https://clinicaltrials.gov/study/NCT06080191