KK2223 for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effects of a new treatment, KK2223, for individuals with certain types of T cell lymphoma. It targets patients whose cancer has returned or not responded to previous treatments. The trial consists of two parts: the first part tests different doses to determine a safe level, and the second part gathers more information using the safe doses identified in the first part. Suitable candidates have relapsed or hard-to-treat T cell lymphoma and have tried at least one treatment for peripheral T cell lymphoma (PTCL) or two for cutaneous T cell lymphoma (CTCL). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that KK2223 is likely to be safe for humans?
Research has shown that KK2223 remains in the early testing stages to determine its safety for humans. In this first phase of trials, the primary goal is to assess its safety and tolerability. Researchers closely monitor for any side effects and how participants respond to the treatment.
Currently, there is limited solid information about its safety, which is typical for treatments in early trials. Researchers continue to gather data to ensure KK2223 is safe for individuals with relapsed or hard-to-treat peripheral T cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL).
For those considering joining a trial, it's important to understand that at this stage, the treatment is primarily tested to observe bodily reactions and establish a safe dose. This step is crucial to ensure the treatment can eventually help people safely.12345Why do researchers think this study treatment might be promising for lymphoma?
Most treatments for lymphoma, such as chemotherapy and radiation, work by targeting rapidly dividing cells, which can lead to significant side effects as they also affect healthy cells. But KK2223 offers a new approach by specifically targeting and modulating the immune response in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). This targeted mechanism may result in fewer side effects and improved outcomes, which is a significant step forward. Researchers are excited about the potential of KK2223 to provide a more precise and tolerable treatment option for lymphoma patients who have not responded well to traditional therapies.
What evidence suggests that KK2223 might be an effective treatment for lymphoma?
Research is investigating KK2223 to determine its potential in treating certain types of T cell lymphoma, specifically relapsed or refractory peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL). Participants in this trial will join either Part One, which focuses on dose escalation to assess the safety and tolerability of KK2223, or Part Two, which will gather additional data at doses deemed tolerable from Part One. While specific results on KK2223's efficacy are not yet available, it is designed to target specific processes in T cell lymphomas, potentially aiding in managing these conditions. Generally, new treatments for lymphoma have a low approval rate at this stage, but each trial is a crucial step toward finding effective options. Early studies are essential to determine if KK2223 can benefit patients with these challenging cancers.12678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Safety and tolerability of KK2223 are assessed using a BOIN dose-escalation design
Backfill
Additional data collected with dose levels and cohort size based on Part 1 results
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KK2223
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Part 2 will collect additional data, with dose levels and cohort size based on Part 1 results, administering doses approved for tolerability. Backfill cohorts at cleared doses may open, prioritizing Part 1 enrollment.
In Part 1, safety and tolerability of KK2223 in relapsed/refractory PTCL or CTCL patients will be assessed using a BOIN dose-escalation design.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kyowa Kirin, Inc.
Lead Sponsor
Citations
A First-in-Human Study of KK2223 in Participants With ...
The purpose of this study is to determine the safety, tolerability, PK and pharmacodynamics of KK2223 in adult participants with relapsed or refractory ...
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/KYKOF/pressreleases/35742312/kyowa-kirins-new-clinical-trial-a-potential-game-changer-in-t-cell-lymphoma-treatment/Kyowa Kirin's New Clinical Trial: A Potential Game ...
The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KK2223 in adults with relapsed or refractory ...
Clinical trial success rate in lymphoma: fate of trials and ... - PMC
The approval rate of new investigational agent from all phase 1 trials in lymphoma is only 6.1%. The median duration required from phase 1 trials to ...
4.
aging.networkofcare.org
aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT07192471?keyword=%22Lymphoma%2C%20T-Cell%2C%20Peripheral%22San Mateo Clinical Trial A First-in-Human Study of KK2223 ...
This is a Phase 1, multicenter, open-label, non randomized study in participants with relapsed or refractory PTCL or CTCL. This study consists of Part 1 ...
5.
pharmatimes.com
pharmatimes.com/news/kyowa-kirin-announces-positive-interim-data-for-lymphoma-treatment/Kyowa Kirin announces positive interim data for lymphoma ...
Real-world studies show effectiveness of mogamulizumab in routine practice. ... Kyowa Kirin announces positive interim data for lymphoma treatment.
KK 2223 - AdisInsight
KK 2223 is being developed by Kyowa Kirin for the treatment of peripheral T cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL).
7.
researchgate.net
researchgate.net/figure/Safety-data-in-patients-with-R-R-PTCL-and-CTCL_tbl2_379307737Safety data in patients with R/R PTCL and CTCL
Brentuximab vedotin (BV) monotherapy (BV-M) and combination (BV-C) therapies are safe and effective for classical Hodgkin lymphoma (cHL) and CD30-expressing ...
Clinical Features and Outcomes of Primary Cutaneous ... - PMC
An analysis of the survival data revealed that 20% (3/15) of all patients died due to lymphoma (DDL). Twenty percent (3/15) of the patients were ...
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