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RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

This research study is for people in the UK with a type of blood cancer called B-cell lymphoma. This is when the lymphoma hasn't responded well to previous treatments (refractory) or has come back after treatment (relapsed). The study is testing two new medicines, KITE-363 and KITE-753, to understand how well they work and how safe they are. It involves different stages (Phase 1 and Phase 2) which help researchers find the right dose and see if the treatments are helpful. The goal is to find better ways to treat this type of lymphoma.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Kite, A Gilead Company
Enrolment target
247
Start
27 Oct 2021
Estimated completion
01 Feb 2030

What is this study about?

This study, called "Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma," is designed for adults aged 18 and older who have a type of blood cancer called B-cell lymphoma. Specifically, it's for people whose lymphoma has either come back after treatment (relapsed) or hasn't responded to earlier treatments (refractory). The main aim is to carefully study two new medicines, KITE-363 and KITE-753.

Researchers want to understand two key things about these new treatments: firstly, how safe they are, meaning what side effects they might cause; and secondly, how well they work to fight the lymphoma. Before getting the new treatments, participants will receive some standard chemotherapy medicines called Cyclophosphamide and Fludarabine. This is a common step in preparing the body for certain types of new therapies. The study is divided into different stages, Phase 1 and Phase 2, which allows researchers to gather more information gradually and make sure the treatments are as safe and effective as possible.

After a participant receives KITE-363 or KITE-753, their health will continue to be monitored for a very long time, up to 15 years. This is important to fully understand the long-term effects of these new treatments. The information gathered from this study will help doctors and scientists learn more about new ways to treat B-cell lymphoma and potentially improve care for patients in the future.

Key takeaways

  • This study is for adults with B-cell lymphoma that has returned or not responded to previous treatments.
  • It tests two new experimental drugs, KITE-363 and KITE-753.
  • The main goals are to check the safety and effectiveness of these new treatments.
  • Participants will receive some chemotherapy before the new drugs.
  • Long-term follow-up of up to 15 years is expected.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be an adult (18 or older) with B-cell lymphoma that has come back or not responded to previous treatments. Doctors would need to see that your lymphoma can be measured, and your important organs (like your heart, kidneys, and liver) are working well. Your body's ability to make blood cells (bone marrow function) also needs to be healthy enough.

You would not be able to join if you've already had certain types of gene-based cell therapies. You also can't have serious uncontrolled infections or certain long-term conditions like uncontrolled heart problems, specific types of autoimmune diseases needing strong medicines, or a history of certain other cancers or stem cell transplants recently. Careful checks will be done for conditions such as HIV, Hepatitis B, or Hepatitis C, or any active problems in your brain or spinal cord.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have B-cell lymphoma that has come back or not responded to treatment?
  3. Do you have good general organ function (heart, liver, kidneys, etc.)?
  4. Have you not had certain types of gene-based cell therapies in the past?
  5. Do you not have an active uncontrolled infection?
  6. Do you not have certain uncontrolled heart conditions or specific autoimmune diseases requiring strong recent treatment?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have some standard chemotherapy using medicines called Cyclophosphamide and Fludarabine. After this, you would receive either KITE-363 or KITE-753, which are the main drugs being tested. The study involves regular visits to the clinic for check-ups, blood tests, and scans to see how your body is responding to the treatment and to monitor for any side effects. You will be closely looked after during this time.

Once you have received the study drug, your health will continue to be monitored for a very long time, for up to 15 years. This long-term follow-up is important to understand how the new treatments affect people over many years. The study team will explain exactly what this involves, but it usually includes periodic check-ups and tests. The total duration of active treatment and close monitoring may vary, but the overall follow-up is for a significant period.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving new treatments that aren't yet widely available, and your health will be very closely monitored by a dedicated medical team. However, there's no guarantee the new treatments will work for you, and they could have side effects, some of which might be serious. The study treatments (including the chemotherapy) may also affect your fertility. All specific risks and potential side effects will be fully explained before you decide to take part. Remember, you can choose to leave the study at any time, for any reason, without affecting your usual medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banner MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States· Recruiting
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    Verified postcode
    Duarte, United States· Recruiting
  • Stanford Cancer Institute
    Verified postcode
    Stanford, United States· Recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Recruiting
  • Northside Hospital
    Verified postcode
    Atlanta, United States· Recruiting
  • Midwestern Regional Medical Center, Inc.City of Hope Chicago
    Verified postcode
    Park Ridge, United States· Recruiting
  • University of MD, Greenebaum Comprehensive Cancer Center
    Verified postcode
    Baltimore, United States· Recruiting
  • Hackensack University Medical Center
    Verified postcode
    Hackensack, United States· Recruiting
  • Columbia University Irving Medical Center
    Verified postcode
    New York, United States· Recruiting
  • University of Rochester Medical Center
    Verified postcode
    Rochester, United States· Recruiting
  • The Ohio State University Wexner Medical Center - James Cancer Hospital
    Verified postcode
    Columbus, United States· Recruiting
  • The University of Texas, MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting

Common questions

What is B-cell lymphoma?

B-cell lymphoma is a type of cancer that starts in white blood cells called lymphocytes, specifically B cells, which are part of your immune system.

What does 'relapsed and/or refractory' mean?

Relapsed means the cancer has come back after treatment. Refractory means the cancer has not responded to previous treatments.

Are KITE-363 and KITE-753 chemotherapy?

No, they are new experimental treatments. You will receive some standard chemotherapy (Cyclophosphamide and Fludarabine) to prepare your body before you get KITE-363 or KITE-753.

How long will I be followed after treatment?

You will be monitored for a long time, up to 15 years, to understand the long-term effects of the new treatments.

Can I leave the study at any time?

Yes, you can withdraw from the study at any point, and it will not affect your future medical care.

How to find out more

Medical Information

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of KITE-363 or KITE-753 in Participants With Relapsed …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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