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Chimeric Antigen Receptor (CAR) T-cell therapy uses a patient’s own immune cells (T-cells) and modifies them in a lab so they are better at finding and eliminating cancer cells. CAR T-cells are engineered to carry a receptor that binds to a specific protein on cancer cells, like CD19, a protein commonly found in certain blood cancers.

CAR T-cell Therapy is Continuously Being Improved

CAR T-cell is groundbreaking for treating cancer because it uses modified healthy immune cells to eliminate cancer cells. Although its use has good responses, the downside is that side effects like cytokine release syndrome, nervous system side effects, and depletion of CAR-T cells (running out of cells), demand further treatment advancements to create improved CAR T-cells that bind only to cancer cells and last longer in the body, minimizing as much as possible the side effects.

Thanks to research, there is more than one CAR-T cell option, depending on what they were designed to do and the proteins they link to. That’s why CAR T-cell therapy is currently one of the most active areas in research, always looking for improvement.

New Clinical Trial Testing Armored CAR T-Cells

A new Phase I clinical trial is now recruiting patients to test a genetically engineered type of CAR T-cell therapy, known as EGFRt/19-28z/IL-12 CAR T-cells, for people with blood cancers that express CD19 and whose cancer came back after treatment (relapsed) or didn’t respond to other therapies (refractory).

What are Armored CAR T-cells?

These armored CAR T-cells target the CD19 protein found on lymphoma cells, and they also have a protein called interleukin-2 (IL-2), which works as an immune system booster (cytokine). Combined, they improve the immune system against cancer and enhance the T-cells' ability to survive and function for longer.

What is the Purpose of the Trial?

The trial seeks to determine the safety, side effects, and best dose of the armored CAR T-cells. The investigators want to find out if, when adding the gene for IL-12, the modified T-cells may fight cancer cells more effectively and improve the overall immune response.

Who Can Join the Trial?

The trial NCT06343376 includes people who previously received CAR T-cell therapy targeting CD19 but need further treatment. This trial includes patients with the following blood cancers that are CD19 positive:

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Diffuse large B-cell lymphoma (DLBCL)
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High-grade B-cell lymphoma (HGBL)
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Chronic lymphocytic leukemia (CLL)
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Mantle cell lymphoma
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Follicular lymphoma
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Visit the trial page for more information on eligibility criteria.

What is the Clinical Trial Plan?

All the patients who participate in this trial will first undergo a procedure called leukapheresis, where their T-cells are collected. Then, depending on the group they are assigned to, they will receive either:

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EGFRt/19-28z/IL-12 armored CAR T-cells alone, or
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A combination of chemotherapy (cyclophosphamide and fludarabine) followed by the armored CAR T-cells.
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Throughout the trial, various tests will monitor the participants’ health and will consist of heart ultrasound, imaging (PET or CT scans), and bone marrow biopsies, to observe their response to the treatment.

After treatment, patients will be closely monitored for side effects and signs of cancer reappearance, with follow-ups occurring over several months and up to 5 years or for as long as each patient agrees to, to assess long-term safety and effectiveness.

Why is This Clinical Trial Important?

This trial represents an exciting new step in CAR T-cell therapy, potentially offering a more effective treatment option for blood cancer patients. By enhancing T-cell function through the addition of IL-12, researchers hope to improve outcomes for patients who have limited options left. If you want to learn more or participate in this trial, it is important to discuss the risks and benefits with your healthcare provider.

If you’re interested in looking for more clinical trials, access HealthTree’s Clinical Trial Finder for free!

Sources:

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Are you curious about what clinical trials are and the benefits of participating in one? Learn about how clinical trials work below. This new understanding can empower you to open the door to innovative treatment options for cancer.

What are Clinical Trials?

Clinical trials, also known as interventional studies, derive their name from being conducted for people or “clinical” subjects. They are led by a principal investigator (PI), who is usually a doctor. The goal of clinical trials is to improve patients' length and health-related quality of life through various medical interventions.

Areas covered by clinical trials may include:

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Comparing the current FDA-approved standard care medicines against newer, potentially more effective treatments
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Therapies that the FDA has approved, but they look at different ways of administering the treatments, such as in combinations or different doses
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Test how new treatments work for a particular disease in a controlled and closely monitored environment
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Strategies to reduce side effects related to cancer or its treatments
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Health-related quality of life patient surveys
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Evaluating new medical devices
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How Can Clinical Trials Benefit Me?

Possible benefits you may receive by participating in a clinical trial include:

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Early access to effective new treatments if they prove successful
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Enhanced medical attention from specialized healthcare professionals
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Thorough monitoring for any side effects
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An opportunity to actively participate in your healthcare decisions
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The chance to aid in the advancement of cancer research and help future patients
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The care you receive, including its treatments, may be fully financially covered by the study
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Possible risks of participating in a clinical trial may include:

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A trial can sometimes require more time and medical attention, such as doctor visits, phone calls, more treatments, a hospital stay, or a more complicated treatment regimen
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Side effects the doctor did not anticipate from the treatment
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New treatments are not always better than current treatments
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The new treatment may not work for you, even if it works for other patients
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If the study is double-blind, you may not know which treatment you’ll be assigned to take
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Is it Free to Participate in a Clinical Trial?

What you may pay for in a clinical trial can vary. Typically, the trial's sponsors cover the treatment, but associated care costs like blood tests might not be included and could require insurance coverage. Ask the principal investigator of the trial any questions you have regarding finances, such as whether expenses related to travel or meals during the study period are reimbursed.

To prepare against justifying the trial’s costs as medically necessary for your insurance, you might need to compile a packet of supportive materials, such as relevant medical studies, a letter from your doctor, or endorsements from patient advocacy groups. The trial coordinator can assist you in assembling these documents.

A note about NIH studies: Clinical trials conducted by the National Institutes of Health (NIH) are free with no insurance involved. Travel costs may be covered in certain cases.

Can I Get Paid to Participate in a Clinical Trial?

Some clinical trials, like Phase I studies involving healthy individuals, may offer compensation ranging from $10-$20 an hour. However, Phase I studies involving people with cancer generally do not pay for participation.

How to find paid clinical trials: To learn if the study you would like to participate in compensates volunteers, please read the trial’s informed consent form. You can also contact the study’s principal investigator for financial-related questions.

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How Do Clinical Trials Work?

Who Can Join a Clinical Trial?

Each clinical trial has rules called eligibility criteria that dictate who can join the study. These include inclusion and exclusion criteria and are set up to preserve the health-related safety of the participants.

Eligibility criteria may include factors like:

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Age
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Prior medications taken
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Cancer stage
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Cancer type
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Eastern Cooperative Oncology Group performance status (measures your ability to complete daily tasks)
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Health history (vaccination record, prior surgeries, comorbidities, active infections)
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Ability to understand and willingness to sign a written informed consent document
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These criteria are located on the trial’s page. If you have questions about the study’s criteria, please reach out to the principal investigator whose contact information is also listed on the trial’s page.

What is the Consent Process of a Clinical Trial?

Every clinical trial is governed by a detailed protocol, which includes the treatment plan, the types of medical tests participants might undergo, the number of participants involved, eligibility criteria, and safety information. An extensive informed consent process is integral to this, where potential participants are educated about the trial's objectives, duration, procedures, all potential risks and benefits, and the confidentiality of their medical records.

If you decide to join, you'll sign a consent form summarizing this information, which you can reference at any time. Importantly, signing the form does not waive your right to withdraw from the study at any point. Informed consent is an ongoing process, allowing for updates on trial progress, emerging side effects, or other risks as they become known.

What are the Phases of Clinical Trials?

Clinical trials are only conducted after preclinical research is finished, a period when the treatment is evaluated not on people. The medicine only moves forward into a clinical trial if there is enough evidence that the therapy has a good chance of helping individuals.

The phases of clinical trials include:

PHASE 0

Phase 0 trials are the first clinical trials that involve people. This phase aims to learn how a medicine is processed in the body, how it affects the body, and whether it reaches cancer cells. A minimal dose of medicine is given to about 10 to 15 people.

PHASE I

This phase is generally tested in a small group of 15 to 30 patients and seeks to find out:

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If the new treatment is safe (fewest side effects)
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The best way to give the new treatment, such as by mouth or by vein, and at what dose
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If there are signs that cancer responds to the new treatment
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PHASE II

Phase II trials are conducted in groups of less than 100 patients to further analyze the safety of medicines and determine whether they work.

PHASE III

The purpose of the phase III trial is to compare the new medicine to the current medicine it could replace. This phase monitors each medicine's side effects and determines which works better. It is tested in hundreds to thousands of patients.

Patients who enroll in a Phase III clinical trial have a chance of being in one of the following randomly selected groups:

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Control group: Receives the current standard treatment
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Study group: Receives the new treatment being tested
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You don’t get to choose which group you are in; this is assigned at random. You might also not know which group you’re in until the trial ends.

PHASE IV

Phase IV trials continue testing new medicines that the FDA has recently approved. The medicine is tested in hundreds to thousands of patients worldwide, allowing for a better understanding of its short—and long-term side effects, safety, and benefits.

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How Long Do Clinical Trials Take?

In general, the amount of time a study takes varies by phase. Other factors like how long it takes to enroll participants and what the study is trying to accomplish can also influence time.

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Phase I: The shortest phase, usually takes less than a year to complete
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Phase II: Often lasts up to two years
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Phase III: Can last up to 5 years
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Phase IV: Can last several years
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Phases II-IV of a clinical trial can often take several years because time is needed to study the long-term effects of a treatment. Your participation in the trial, however, may be shorter than its full duration because participants can join the study at different times.

Am I Allowed to Quit a Clinical Trial?

As a volunteer, you have the freedom to discontinue your involvement in a clinical trial whenever you choose. It is advisable to consult your doctor before making this decision to discuss potential health implications, the safest method to stop the medications, and alternative treatment options available to you. If you find that the clinical trial is not meeting your needs, you may opt to withdraw and explore other trials or different treatment approaches.

How Do I Find a Clinical Trial?

Now that you understand the gist of clinical trials, how do you find one that suits your needs? Strategies may include:

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Ask a cancer specialist about clinical trials you are eligible for
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Review HealthTree’s clinical trial finder by clicking here
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If you are not finding a clinical trial on HealthTree’s site, you can also visit clinicaltrials.gov for a more comprehensive list
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Stay tuned to HealthTree news articles, which cover some of the latest updates on blood cancer clinical trials
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Conclusion

Participating in a clinical trial that aligns with your needs may help provide you access to some of the best new therapies that are not readily available to the general public. Your participation can also help researchers and doctors gather data that improves the treatment landscape for other people with cancer.

Access HealthTree’s Clinical Trial Finder

Click the button below to access HealthTree’s clinical trial finder, opening the door to potential innovative treatment options.

Find Clinical Trials

Sources:

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NIH Clinical Research Trials and You
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Deciding to Join a Clinical Trial
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Who Pays for Clinical Trials?
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How Long Does Each Clinical Trial Last?
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NIH Clinical Center: Are Clinical Studies for You?
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The IRB’s Perspective: Determining Optimal Compensation for Clinical Trial Participants

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