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Monoclonal Antibodies
KT-413 for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Kymera Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of entry on study through progression, up to 18 months
Awards & highlights
Study Summary
This trial will study the safety and how well KT-413 works in patients with relapsed or refractory non-Hodgkin's lymphoma.
Eligible Conditions
- Non-Hodgkin's Lymphoma
- MYD88 Gene Mutation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of entry on study through progression, up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of entry on study through progression, up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Event Parameters
Clinical Laboratory Abnormalities
Dose recommended for future studies
+3 moreSecondary outcome measures
Amount of KT-413 excreted in urine from time zero to last collected timepoint (Ae0-t)
Area under the plasma concentration versus time curve for KT-413 from time zero to last quantifiable time point (AUC0-t)
Disease Control Rate (DCR) as assessed by the investigator
+7 moreOther outcome measures
KT-413 levels in peripheral blood mononuclear cells
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase 1b Dose Expansion MYD88WTExperimental Treatment1 Intervention
KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 wild type DLBCL.
Group II: Phase 1b Dose Expansion MYD88MTExperimental Treatment1 Intervention
KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 mutant DLBCL.
Group III: Phase 1a Dose EscalationExperimental Treatment1 Intervention
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Who is running the clinical trial?
Kymera Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
598 Total Patients Enrolled
Ashwin Gollerkeri, MDStudy DirectorKymera Therapeutics, Inc.
4 Previous Clinical Trials
344 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your organs and bone marrow are healthy and functioning properly without the need for additional medications.You have recently had a heart attack within the past 3 months.You have been diagnosed with relapsed or refractory Primary Central Nervous System Lymphoma (PCNSL) based on tests of your cerebrospinal fluid or a biopsy. You may still be eligible if your doctor believes there are no other treatment options.You can still participate in the study if you have cancer that has spread to your brain, as long as you meet the other requirements. This includes people who have cancer in both their body and brain at the same time, or those who had cancer in their body but it has now come back only in the brain.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a Dose Escalation
- Group 2: Phase 1b Dose Expansion MYD88MT
- Group 3: Phase 1b Dose Expansion MYD88WT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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