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Cldn6 Car-T(A)

A groundbreaking clinical trial is underway to evaluate the safety and effectiveness of CLDN6 CAR-T(A), an innovative cell therapy, in patients with advanced solid tumors. This Phase I/IIa study aims to assess the potential of this treatment, both alone and in combination with a specialized RNA-based vaccine, offering hope for patients with limited treatment options.

Table of Contents

What is CLDN6 CAR-T(A)?

CLDN6 CAR-T(A) is an innovative investigational cell therapy being developed for the treatment of advanced solid tumors[1]. It belongs to a class of treatments known as CAR-T cell therapies, which use a patient’s own immune cells to fight cancer. The “CLDN6” in its name refers to Claudin 6, a specific protein found on some cancer cells that this therapy targets[1].

How does it work?

CLDN6 CAR-T(A) works by modifying a patient’s own T cells (a type of immune cell) to recognize and attack cancer cells that express the CLDN6 protein. Here’s a simplified explanation of the process:

  1. T cells are collected from the patient’s blood.
  2. These cells are genetically modified in a laboratory using a gamma-retroviral self-inactivating vector to produce a special receptor called a CAR (Chimeric Antigen Receptor) that can recognize CLDN6[1].
  3. The modified cells are then multiplied in the lab.
  4. Finally, these CAR-T cells are infused back into the patient, where they can seek out and destroy cancer cells expressing CLDN6.

What conditions does it target?

CLDN6 CAR-T(A) is being investigated for the treatment of several types of advanced solid tumors, including:

  • Malignant solid tumors: Various types of cancers that form solid masses[1]
  • Carcinoma of unknown primary: Cancer that has spread in the body but the original site where it started is unknown
  • Testicular cancer
  • Non-small cell lung cancer

The therapy is designed for patients whose cancers are metastatic (spread to other parts of the body) or unresectable (cannot be completely removed by surgery), and for whom standard treatments are no longer effective or suitable[1].

Current Clinical Trial

CLDN6 CAR-T(A) is currently being studied in a Phase I/IIa clinical trial. This is a first-in-human study, meaning it’s the first time this specific therapy is being tested in people. The trial aims to:

  • Assess the safety and tolerability of CLDN6 CAR-T(A)
  • Evaluate its preliminary effectiveness in treating advanced solid tumors
  • Compare CLDN6 CAR-T(A) produced by manual and automated processes

The study is also investigating the use of CLDN6 CAR-T(A) in combination with another investigational treatment called CLDN6 RNA-LPX, which is a vaccine designed to enhance the effectiveness of the CAR-T cells[1].

Who is eligible for the trial?

The trial has specific eligibility criteria, including:

  • Patients must be 18 years or older
  • Have a confirmed solid tumor that expresses the CLDN6 protein
  • Have cancer that is metastatic or unresectable
  • Have no available standard therapy likely to provide clinical benefit
  • Have adequate organ function (bone marrow, liver, kidneys)
  • Be able to attend all required trial visits

There are also several exclusion criteria, such as having received prior CAR-T therapy (except CLDN6 CAR-T) or recent live virus vaccinations[1].

Safety and Efficacy Evaluation

The trial will closely monitor patients for side effects, particularly looking at:

  • Treatment-emergent adverse events (TEAEs), especially those that are severe or serious
  • Changes in levels of immune factors in the blood
  • How well tumors respond to the treatment (measured by standard criteria for solid tumors)
  • How long any positive responses to the treatment last

These assessments will help determine the safety profile of CLDN6 CAR-T(A) and provide initial insights into its effectiveness against solid tumors[1].

How is CLDN6 CAR-T(A) administered?

CLDN6 CAR-T(A) is given as an intravenous bolus, which means it’s injected directly into a vein. Before receiving the CAR-T cells, patients typically undergo a process called lymphodepletion, which helps prepare their body to receive the new cells[1].

It’s important to note that as an investigational therapy, CLDN6 CAR-T(A) is only available through clinical trials at this time. Patients interested in this treatment should discuss their options with their oncologist to determine if they might be eligible for any ongoing studies.

Aspect Details
Study Type Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts
Treatment CLDN6 CAR-T(A) with or without CLDN6 RNA-LPX vaccine
Target Population Patients with CLDN6-positive relapsed or refractory advanced solid tumors
Primary Objectives Assess safety, tolerability, and comparability of manual and automated CLDN6 CAR-T processes
Secondary Objectives Evaluate immune factor profiles and anti-tumor activity
Key Eligibility Criteria CLDN6-positive tumor, adequate organ function, measurable disease, age ≥18 years
Primary Endpoints Treatment-emergent adverse events, dose-limiting toxicities
Secondary Endpoints Changes in immune factors, objective response rate, duration of response

FAQ

  • What is CLDN6 CAR-T(A)? CLDN6 CAR-T(A) is a type of cell therapy where a patient's own T cells are modified to target claudin 6 (CLDN6), a protein found on certain cancer cells. This therapy is designed to help the immune system fight against advanced solid tumors.
  • Who is eligible for this clinical trial? Eligible participants are adults (18 years or older) with CLDN6-positive advanced solid tumors that are metastatic or unresectable. They must have no available standard therapy likely to benefit them or be unsuitable for such therapy.
  • What is the main goal of this clinical trial? The main goal is to assess the safety and tolerability of CLDN6 CAR-T(A), both alone and in combination with a CLDN6 RNA-based vaccine. The study also aims to evaluate the treatment's effectiveness in fighting tumors.
  • How is the treatment administered? CLDN6 CAR-T(A) is administered as a dispersion for infusion, which means it's given intravenously (through a vein) as a single dose. Some patients may also receive the RNA-based vaccine as part of the study.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include access to a novel treatment that may help fight advanced tumors. Risks may include side effects related to the therapy, which will be closely monitored. The study team will provide detailed information about potential risks and benefits to all participants.

Ongoing Clinical Trials on Cldn6 Car-T(A)

  • A Study of CLDN6 CAR-T Cell Therapy With or Without CLDN6 RNA-LPX Vaccine in Patients With CLDN6-Positive Advanced Solid Tumors That Returned or Did Not Respond to Treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany The Netherlands Sweden

Glossary

  • CLDN6 CAR-T(A): A type of cell therapy where a patient's T cells are genetically modified to target claudin 6 (CLDN6), a protein found on certain cancer cells.
  • Solid Tumor: A mass of abnormal cells that doesn't contain cysts or liquid areas. Solid tumors can occur in various organs, such as the lungs, breast, or colon.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Unresectable: A tumor that cannot be removed completely through surgery.
  • RNA-LPX: A liposomally-formulated vaccine containing ribonucleic acid (RNA) that encodes for the CLDN6 protein.
  • Immunohistochemistry (IHC): A laboratory method used to detect specific proteins in tissue samples, often used to diagnose certain types of cancer.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standardized way to measure how well a cancer patient responds to treatment.
  • Dose-limiting toxicity (DLT): Side effects of a treatment that are severe enough to prevent an increase in dose or require a dose reduction.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-cldn6-car-t-and-cldn6-rna-lpx-in-patients-with-advanced-solid-tumors/