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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of entry on study through progression, up to 18 months for reporting.

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 more

Secondary 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 more

Other 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

Do I qualify?Apply below to find out

Find a Location

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

Media Library

KT-413 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05233033 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Phase 1a Dose Escalation, Phase 1b Dose Expansion MYD88MT, Phase 1b Dose Expansion MYD88WT

Non-Hodgkin's Lymphoma Clinical Trial 2023: KT-413 Highlights & Side Effects. Trial Name: NCT05233033 — Phase 1

KT-413 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233033 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare centers are administering this experiment?

"This clinical trial has locations in several cities, such as Washington D.C., Houston and Louisville. Additionally, there are 6 other enrolment sites that participants can attend for their participation."

Answered by AI

Could you detail the key aims of this trial?

"The primary endpoint of this experiment, which will be monitored over the initial three weeks of treatment, is to determine an optimal dosage for future trials. Secondary endpoints include quantifying KT-413 excretion from baseline (Ae0-t) in Phase 1a/1b, evaluating progression-free survival as judged by researchers during Phase 1b, and measuring maximum plasma levels of KT-413 in both phases one A and B."

Answered by AI

What is the scope of recruitment for this research effort?

"Affirmative. The clinical trial's webpage on clinicaltrials.gov confirms that recruitment is underway, beginning from June 13th 2022 and last updated November 15th 2022. A total of 80 patients are to be enlisted across 6 different sites for the study."

Answered by AI

Has the FDA granted its stamp of approval to KT-413?

"The risk associated with KT-413 was rated at a 1 since the clinical trial is still in its initial testing phase, meaning data related to safety and effectiveness are limited."

Answered by AI

Is this research endeavor still enrolling participants?

"The most current information posted on clinicaltrials.gov states that this trial is actively recruiting participants, with the initial posting having been made on June 13th 2022 and updated lastly on November 15th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients With Relapsed or Refractory B-cell NHL

2022. "Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients With Relapsed or Refractory B-cell NHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233033.