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19Cp02

Clinical trials are currently underway to evaluate the safety and effectiveness of 19Cp02, an innovative CAR T-cell therapy designed to treat patients with relapsed or refractory B-cell non-Hodgkin lymphoma and other blood cancers. This groundbreaking treatment involves genetically modifying a patient’s own T-cells to target cancer cells more effectively. The trials aim to assess the therapy’s potential in improving outcomes for patients who have not responded well to conventional treatments.

Table of Contents

What is 19CP02?

19CP02, also known as GLPG5101, is an innovative CAR T-cell therapy being developed to treat certain types of blood cancers[1]. CAR T-cell therapy is a type of treatment that uses a patient’s own immune cells, specifically T cells, which are modified in a laboratory to better recognize and fight cancer cells.

How Does 19CP02 Work?

19CP02 works by targeting a specific protein called CD19, which is found on the surface of certain cancer cells[1]. The therapy involves:

  1. Collecting T cells from the patient’s blood
  2. Modifying these T cells in a laboratory to express a special receptor called anti-CD19 CAR (Chimeric Antigen Receptor)
  3. Multiplying these modified T cells
  4. Infusing the modified T cells back into the patient’s bloodstream

Once infused, these modified T cells can recognize and attack cancer cells that have the CD19 protein on their surface.

What Conditions Does 19CP02 Treat?

19CP02 is being studied for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL)[1]. This includes several subtypes of NHL:

  • Diffuse Large B-Cell Lymphoma (DLBCL): An aggressive form of NHL
  • Follicular Lymphoma (FL): Grades 1, 2, or 3A
  • Marginal Zone Lymphoma (MZL)
  • Mantle Cell Lymphoma (MCL)
  • Burkitt Lymphoma (BL)
  • Primary Central Nervous System Lymphoma (PCNSL)

“Relapsed” means the cancer has returned after treatment, while “refractory” means the cancer has not responded to treatment[1].

Clinical Trials and Research

19CP02 is currently being studied in clinical trials to evaluate its safety and effectiveness. The main clinical trial is a Phase I/II study with two primary objectives[1]:

  • Phase I: To evaluate the safety of 19CP02 and determine the recommended dose for Phase II
  • Phase II: To evaluate how well 19CP02 works in treating different subtypes of NHL

The researchers are looking at several factors, including[1]:

  • How many patients respond to the treatment (objective response rate)
  • How long the response lasts
  • How long patients survive without their disease getting worse (progression-free survival)
  • Overall survival rates

Eligibility for 19CP02 Treatment

To be eligible for treatment with 19CP02 in the clinical trial, patients must meet certain criteria[1]:

  • Be 18 years or older
  • Have a confirmed diagnosis of one of the NHL subtypes mentioned earlier
  • Have relapsed or refractory disease
  • Have measurable disease according to specific criteria
  • Have adequate bone marrow, kidney, liver, and lung function

Some conditions may exclude a patient from participating, such as[1]:

  • Richter’s transformation (a rare condition where chronic lymphocytic leukemia or small lymphocytic lymphoma transforms into an aggressive lymphoma)
  • Certain prior treatments
  • Active central nervous system involvement by the lymphoma
  • Infection with HIV, hepatitis B, or hepatitis C virus

Safety and Side Effects

As with any medical treatment, 19CP02 may cause side effects. The clinical trials are closely monitoring for any adverse events, including[1]:

  • Cytokine release syndrome: A condition that can cause fever, low blood pressure, and breathing difficulties
  • Neurological effects: Such as confusion, seizures, or difficulty speaking
  • Changes in blood cell counts
  • Infections

The researchers are carefully evaluating these potential side effects to ensure patient safety.

Long-Term Follow-Up

Because 19CP02 is a new type of therapy, researchers are conducting a long-term follow-up study to monitor patients for up to 15 years after treatment[2]. This study aims to:

  • Evaluate the long-term safety of the treatment
  • Monitor for any delayed side effects
  • Track the long-term effectiveness of the treatment
  • Check for the presence of the modified T cells in the body over time

This long-term follow-up is crucial to fully understand the benefits and potential risks of 19CP02 therapy.

Aspect Details
Drug Name 19Cp02 (GLPG5101)
Type of Therapy CAR T-cell therapy
Target Conditions Relapsed/refractory B-cell non-Hodgkin lymphoma, CLL, SLL, multiple myeloma
Administration Method Intravenous infusion
Trial Phases Phase I/II and long-term follow-up (up to 15 years)
Primary Objectives Evaluate safety, determine recommended dose, assess efficacy
Key Endpoints Incidence of adverse events, objective response, survival rates
Eligibility Adults (≥18 years) with confirmed diagnosis of specified lymphomas

FAQ

  • What is 19Cp02? 19Cp02 is a type of CAR T-cell therapy, which involves modifying a patient's own T-cells to target cancer cells. It is specifically designed to treat relapsed or refractory B-cell non-Hodgkin lymphoma and other blood cancers.
  • What types of cancer is 19Cp02 being tested for? 19Cp02 is being tested for various types of B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), Burkitt's lymphoma (BL), and primary central nervous system lymphoma (PCNSL). It is also being evaluated for chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and multiple myeloma.
  • How is 19Cp02 administered to patients? 19Cp02 is administered to patients through intravenous infusion. This means the modified T-cells are delivered directly into the bloodstream.
  • What are the main objectives of the clinical trials for 19Cp02? The main objectives of the clinical trials are to evaluate the safety of 19Cp02, determine the recommended dose for Phase 2 trials, assess its efficacy in treating different types of non-Hodgkin lymphoma, and study its long-term effects for up to 15 years after treatment.
  • What are some of the potential side effects being monitored in the 19Cp02 trials? The trials are monitoring for various side effects, including serious adverse events related to the therapy, the presence of CAR transgene levels in the blood, and the potential development of replication-competent lentivirus. They are also tracking long-term effects on patients' overall health and cancer progression.

Ongoing Clinical Trials on 19Cp02

  • Long-Term Safety Study of BCMACP03, BCN-CP01, and 19CP02 for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, CLL, SLL, or Multiple Myeloma

    Recruiting

    3 1 1
    Investigated drugs:
    Belgium Finland The Netherlands Spain

  • Study on the Safety and Effectiveness of 19CP02 for Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

    Not recruiting

    2 1 1
    Investigated drugs:
    Belgium Finland The Netherlands

Glossary

  • CAR T-cell therapy: A type of treatment that uses a patient's own T-cells (a type of immune cell) that have been genetically modified to better recognize and attack cancer cells.
  • B-cell non-Hodgkin lymphoma: A type of cancer that starts in white blood cells called lymphocytes, specifically in B-cells, which are part of the body's immune system.
  • Relapsed/refractory disease: Cancer that has returned after treatment (relapsed) or has not responded to initial treatment (refractory).
  • ECOG performance status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Lugano classification: A set of criteria used to evaluate the response to treatment in lymphoma patients.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Dose-limiting toxicities (DLTs): Side effects of a drug or treatment that are severe enough to prevent an increase in dose or level of that treatment.
  • Objective response (OR): A measurable response to treatment, typically referring to a reduction in tumor size or cancer symptoms.
  • Minimal residual disease (MRD): Small numbers of cancer cells that remain in the body during or after treatment.
  • Replication-competent lentivirus (RCL): A virus used in gene therapy that has regained the ability to replicate, which could potentially cause safety concerns.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-19cp02-for-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma/
  2. http://clinicaltrials.eu/trial/long-term-safety-study-of-bcmacp03-bcn-cp01-and-19cp02-for-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-cll-sll-or-multiple-myeloma/