#1 Clinical Trials Search in Europe

Ptg-Carcik-Cd19

PTG-CARCIK-CD19 is an innovative cell therapy being studied in clinical trials for patients with relapsed or refractory B-cell malignancies, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and B-cell precursor acute lymphoblastic leukemia. This treatment uses genetically modified immune cells to target cancer cells expressing the CD19 protein, offering hope for patients who have not responded to other treatments.

Table of Contents

What is PTG-CARCIK-CD19?

PTG-CARCIK-CD19 is an innovative cell therapy being developed for the treatment of certain blood cancers[1]. It belongs to a class of treatments known as CAR (Chimeric Antigen Receptor) therapies, which use modified immune cells to fight cancer. Specifically, PTG-CARCIK-CD19 uses a type of immune cell called CIK (Cytokine-Induced Killer) cells that have been genetically modified to target cancer cells expressing a protein called CD19[2].

How Does PTG-CARCIK-CD19 Work?

PTG-CARCIK-CD19 works by using a patient’s own immune system to fight cancer. Here’s a simplified explanation of the process:

  1. Immune cells are collected from a donor (usually a family member who is at least partially matched to the patient’s tissue type).
  2. These cells are then genetically modified in a laboratory using a transposon (a piece of DNA that can move from one location to another) to express a receptor that recognizes CD19, a protein found on many types of cancer cells[1].
  3. The modified cells, now called CARCIK-CD19 cells, are grown in large numbers.
  4. The CARCIK-CD19 cells are then infused back into the patient’s body through an intravenous infusion (a process similar to a blood transfusion)[1].
  5. Once in the body, these cells can recognize and attack cancer cells that have CD19 on their surface.

What Conditions Does PTG-CARCIK-CD19 Treat?

PTG-CARCIK-CD19 is being studied for the treatment of several types of blood cancers that have not responded well to other treatments (known as relapsed or refractory cancers). These include:

  • B-cell Non-Hodgkin Lymphoma (NHL): A type of cancer that starts in white blood cells called lymphocytes[1].
  • Chronic Lymphocytic Leukemia (CLL): A slow-growing cancer of the blood and bone marrow[1].
  • B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL): A fast-growing cancer of certain white blood cells[2].

These conditions all involve cancerous B cells, which typically have the CD19 protein on their surface, making them targets for PTG-CARCIK-CD19 therapy.

Clinical Trials and Research

PTG-CARCIK-CD19 is currently being studied in clinical trials to determine its safety and effectiveness. Two main studies are ongoing:

  1. A Phase I/II trial for adults and children with relapsed or refractory B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia[1].
  2. A Phase II study for pediatric and adult patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia[2].

These trials aim to determine the appropriate dose of the treatment, evaluate its safety, and measure how well it works in treating these cancers.

Eligibility for Treatment

PTG-CARCIK-CD19 is being studied in patients who have not responded well to at least two prior lines of treatment. Some key eligibility criteria include:

  • Age: Both children (typically 1-17 years old) and adults (18 years and older) may be eligible, depending on the specific trial[1][2].
  • Cancer type: Patients must have a confirmed diagnosis of one of the cancers being studied (NHL, CLL, or BCP-ALL).
  • Previous treatments: Patients must have relapsed after or been refractory to at least two prior lines of treatment[1].
  • General health: Patients must be in relatively good overall health, as measured by performance status scales.

It’s important to note that there are also several exclusion criteria, such as certain active infections or other medical conditions, that might make a patient ineligible for the treatment[1][2].

Potential Benefits and Outcomes

The main goals of PTG-CARCIK-CD19 treatment are to:

  • Achieve an overall response to the treatment, meaning a reduction in cancer cells[1][2].
  • Improve the duration of response, or how long the treatment continues to work[2].
  • Increase overall survival for patients with these difficult-to-treat cancers[2].

Researchers are measuring these outcomes in the ongoing clinical trials to determine how effective the treatment is.

Safety and Side Effects

As with any new treatment, safety is a crucial concern. The clinical trials are closely monitoring for any side effects or adverse events. Some potential side effects that are being watched for include:

  • Cytokine Release Syndrome (CRS): A condition where the immune system becomes overly activated, causing symptoms like fever, low blood pressure, and difficulty breathing.
  • Neurological effects: Such as confusion, seizures, or other brain-related issues.
  • Infections: Due to the impact on the immune system.
  • Prolonged low blood cell counts: Which could increase the risk of bleeding or infections[1][2].

It’s important to note that while these side effects are possible, they are being carefully monitored and managed in the clinical trial setting. The researchers are working to find the safest and most effective way to use this new treatment.

Aspect Details
Drug Name PTG-CARCIK-CD19
Type of Therapy Cell therapy using genetically modified immune cells
Target Diseases Relapsed/refractory B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, B-cell precursor acute lymphoblastic leukemia
Administration Intravenous infusion
Trial Phases Phase I/II and Phase II
Key Objectives Determine safety, find optimal dose, evaluate efficacy (response rates, duration of response, survival)
Patient Age Range 1-75 years old
Notable Inclusion Criteria Relapsed/refractory disease, measurable disease, specific performance status scores
Notable Exclusion Criteria Active infections, rapidly progressive disease, certain organ dysfunctions

FAQ

  • What is PTG-CARCIK-CD19? PTG-CARCIK-CD19 is a type of cell therapy that uses genetically modified immune cells to target cancer cells expressing the CD19 protein. It's being studied for patients with certain types of B-cell cancers that haven't responded well to other treatments.
  • What types of cancer is PTG-CARCIK-CD19 being tested for? PTG-CARCIK-CD19 is being tested in clinical trials for patients with relapsed or refractory B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, and B-cell precursor acute lymphoblastic leukemia.
  • How is PTG-CARCIK-CD19 administered? PTG-CARCIK-CD19 is given as an intravenous infusion, which means it's delivered directly into the bloodstream through a vein.
  • Who is eligible for these clinical trials? Eligibility varies, but generally includes patients aged 1-75 years with specific B-cell cancers that have relapsed or not responded to at least two prior lines of treatment. Patients must also meet certain health criteria and have measurable disease.
  • What are the main goals of these clinical trials? The main goals are to determine the safety of PTG-CARCIK-CD19, find the right dose, and evaluate how effective it is in treating these cancers. Researchers are looking at factors such as overall response rate, duration of response, and survival rates.

Ongoing Clinical Trials on Ptg-Carcik-Cd19

  • Study on PTG-CARCIK-CD19 for Adults and Children with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

    Recruiting

    1 1
    Investigated drugs:
    Italy

Glossary

  • Allogeneic: Cells or tissues that come from a genetically different donor of the same species. In these trials, the CARCIK-CD19 cells may come from a family member or other donor.
  • CAR-T cells: Chimeric Antigen Receptor T cells. These are T cells (a type of immune cell) that have been genetically modified to target specific proteins on cancer cells.
  • CD19: A protein found on the surface of B cells, including many types of cancerous B cells. It's the target for the CARCIK-CD19 therapy.
  • Chronic Lymphocytic Leukemia (CLL): A type of cancer that affects white blood cells called lymphocytes, usually developing slowly over time.
  • Non-Hodgkin Lymphoma (NHL): A group of blood cancers that develop from lymphocytes. It's called 'non-Hodgkin' to distinguish it from a different disease called Hodgkin lymphoma.
  • B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL): A fast-growing cancer of immature B cells (a type of white blood cell) in the bone marrow.
  • Relapsed: When cancer returns after a period of improvement.
  • Refractory: When cancer does not respond to treatment or stops responding after initial improvement.
  • Measurable Residual Disease (MRD): Small numbers of cancer cells that remain during or after treatment, often undetectable by standard tests.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): How long a patient's positive response to treatment lasts.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-on-ptg-carcik-cd19-for-adults-and-children-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-and-chronic-lymphocytic-leukemia/
  2. http://clinicaltrials.eu/trial/study-of-carcik-cd19-cells-for-patients-with-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic-leukemia/