Non Hodgkin LymphomaPhase 1NCT05233033
Safety, PK/PD, and Clinical Activity of KT-413 in Adult Patients with Relapsed or Refractory B-cell NHL
A Phase 1 study testing KT-413 in people with Non Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by Kymera Therapeutics, Inc. at 8 sites in 2 countries.
Trial summary
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in patients with R/R NHL. The Phase 1a stage of the study will explore escalating doses of single-agent KT-413. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, DLBCL
- What is being tested?
- KT-413
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 13 Jun 2022to 28 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1a Only:
- Histologically confirmed diagnosis of B-cell NHL according to the 2016 World Health Organization (WHO) classification. Diffuse large B-cell lymphoma (DLBCL) includes: DLBCL not otherwise specified (NOS) with or without MYC and BCL2 and/or BCL6 rearrangements; Epstein-Barr virus (EBV) positive DLBCL, NOS; human herpesvirus 8 (HHV8) positive DLBCL, NOS; DLBCL associated with chronic inflammation; and Primary cutaneous DLBCL, leg type. Patients with indolent lymphoma are eligible if they meet criteria for systemic treatment.
- Clinicopathological diagnosis of Waldenström's Macroglobulinemia (WM) based on the consensus panel criteria from the Second International Workshop on WM
- Histologically/cytologically confirmed relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL) by cerebrospinal fluid (CSF) or biopsy. PCNSL patients are considered eligible if the Investigator believes that there is no other reasonable treatment alternative.
- Note: Patients with HIV-associated PCNSL are not eligible.
- Note: Patients with secondary CNS metastases are eligible assuming they meet other study criteria. Patients with secondary CNS metastases include those who have synchronous systemic and CNS involvement or those who have been previously treated and relapsed with isolated CNS involvement.
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- Phase 1b Only: Histologically confirmed diagnosis of DLBCL according to the 2016 WHO classification including: DLBCL not otherwise specified (NOS) with or without MYC and BCL2 and/or BCL6 rearrangements; Epstein-Barr virus (EBV) positive DLBCL, NOS; HHV8+ DLBCL, NOS; DLBCL associated with chronic inflammation; and Primary cutaneous DLBCL, leg type.
- Disease relapsed and/or refractory to at least 2 accepted standard systemic regimens for all indications except PCNSL. For PCNSL, patients must be relapsed and/or refractory to at least 1 prior regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
- Adequate organ and bone marrow function, in the absence of growth factors
- Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol
Who cannot join
- Infection with hepatitis B (HBV), hepatitis C (HCV), or active viral infection with human immunodeficiency virus (HIV).
- Radiation treatment within 4 weeks prior to first dose of study drug, unless the tumor site continues to increase in size after the patient has completed radiotherapy treatment.
- Major surgery requiring general anesthesia within 4 weeks prior to first dose of study drug, unless the tumor site continues to increase in size after the patient has completed radiotherapy treatment.
- Ongoing unstable cardiovascular function including history of myocardial infarction within 3 months of planned start of study drug.
- Patient has not recovered from any clinically significant AEs of previous treatments to pre-treatment baseline or Grade 1 prior to first dose of study drug.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
Henry Ford Health System
Detroit, Michigan, 48202
MD Anderson Cancer Center
Houston, Texas, 77030
Norton Cancer Institute
Louisville, Kentucky, 40207
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United Kingdom2 sites
University College London Hospitals
London
University Hospital Southampton NHS Foundation Trust
Southampton
About this study
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, PK/PD, and Clinical Activity of Intravenously Administered KT-413 in Adult Patients with Relapsed or Refractory B-cell NHL
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in patients with R/R NHL. The Phase 1a stage of the study will explore escalating doses of single-agent KT-413. The Phase 1b stage will be split into 2 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in MYD88 mutant and MYD88 wild-type R/R DLBCL.
- Being tested
- KT-413
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT-413Drug
KT-413 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined dose level.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Not described Receives: Drug: KT-413 |
| Phase 1b Dose Expansion MYD88MT | Experimental | KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 mutant DLBCL. Receives: Drug: KT-413 |
| Phase 1b Dose Expansion MYD88WT | Experimental | KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 wild type DLBCL. Receives: Drug: KT-413 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the Maximum Tolerated Dose (MTD)
Phase 1a
Measured: Within first 3 weeks of treatment
Number of Participants with protocol specified Dose Limiting Toxicities (DLTs)
Phase 1a
Measured: Within first 3 weeks of treatment
Dose recommended for future studies
Phase 1a/1b
Measured: Within first 3 weeks of treatment
Clinical Laboratory Abnormalities
Incidence and severity of clinical laboratory abnormalities in serum chemistry, hematology, coagulation parameters, and urinalysis tests as assessed by CTCAE v5.0 (Phase 1a/1b)
Measured: Clinical laboratory abnormalities will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Adverse Event Parameters
Incidence and severity of adverse events as assessed by CTCAE v5.0 (Phase 1a/1b)
Measured: Adverse Event Parameters will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
ECG Parameters
Changes in the ECG parameters, including heart rate and measures PR, QRS, QT, and QTc intervals as assessed by CTCAE v5.0 Phase 1a/1b
Measured: ECG Parameters will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Secondary outcomes (10)
Area under the plasma concentration versus time curve for KT-413 from time zero to last quantifiable time point (AUC0-t)
Phase 1a/1b
Measured: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Maximum Plasma Concentration of KT-413 (Cmax)
Phase 1a/1b
Measured: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Time of maximum plasma concentration of KT-413 (Tmax)
Phase 1a/1b
Measured: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Half-life of KT-413 [if data permits (T1/2)]
Phase 1a/1b
Measured: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Amount of KT-413 excreted in urine from time zero to last collected timepoint (Ae0-t)
Phase 1a/1b
Measured: Urine samples for PK analysis collected during the first cycle (21 day cycle)
Evidence of clinical activity of KT-413 as determined by Objective Response Rate (ORR)
Phase 1a/1b
Measured: From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Duration of Response (DOR) as assessed by the Investigator
Phase 1a/1b
Measured: From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Progression-free survival (PFS) as assessed by the Investigator
Phase 1b
Measured: From time of entry on study through progression, up to 18 months
Disease Control Rate (DCR) as assessed by the investigator
Phase 1b
Measured: From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Overall Survival (OS) as assessed by the investigator
Phase 1b
Measured: From time of entry on study through death or date last known alive at end of follow-up, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start13 Jun 2022
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashwin Gollerkeri, MD, Study director, Kymera Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233033
- Sponsor's protocol ID
- KT413-DL-101
- Status last verified
- Dec 2024
- First submitted
- 18 Jan 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, PK/PD, and Clinical Activity of Intravenously Administered KT-413 in Adult Patients with Relapsed or Refractory B-cell NHL
- ClinicalTrials.gov ID
- NCT05233033
- Acronym / sponsor ID
- KT413-DL-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Kymera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in patients with R/R NHL. The Phase 1a stage of the study will explore escalating doses of single-agent KT-413. The Phase 1b stage will be split into 2 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/ pharmacodynamics (PK/ PD) of KT-413 in MYD88 mutant and MYD88 wild-type R/R DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: KT-413 |
| Phase 1b Dose Expansion MYD88MT | Experimental | Drug: KT-413KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 mutant DLBCL. |
| Phase 1b Dose Expansion MYD88WT | Experimental | Drug: KT-413KT-413 given at the RP2D identified in Phase 1a Dose Escalation in patients with MYD88 wild type DLBCL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Phase 1a Only:
- Phase 1b Only: Histologically confirmed diagnosis of DLBCL according to the 2016 WHO classification including: DLBCL not otherwise specified (NOS) with or without MYC and BCL2 and/or BCL6 rearrangements; Epstein-Barr virus (EBV) positive DLBCL, NOS; HHV8+ DLBCL, NOS; DLBCL associated with chronic inflammation; and Primary cutaneous DLBCL, leg type.
- Disease relapsed and/or refractory to at least 2 accepted standard systemic regimens for all indications except PCNSL. For PCNSL, patients must be relapsed and/or refractory to at least 1 prior regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
- Adequate organ and bone marrow function, in the absence of growth factors
Key exclusion criteria (5 listed)
- Infection with hepatitis B (HBV), hepatitis C (HCV), or active viral infection with human immunodeficiency virus (HIV).
- Radiation treatment within 4 weeks prior to first dose of study drug, unless the tumor site continues to increase in size after the patient has completed radiotherapy treatment.
- Major surgery requiring general anesthesia within 4 weeks prior to first dose of study drug, unless the tumor site continues to increase in size after the patient has completed radiotherapy treatment.
- Ongoing unstable cardiovascular function including history of myocardial infarction within 3 months of planned start of study drug.
- Patient has not recovered from any clinically significant AEs of previous treatments to pre-treatment baseline or Grade 1 prior to first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KT-413KT-413 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined dose level. | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion MYD88MT, Phase 1b Dose Expansion MYD88WT |
Primary outcome
To establish the Maximum Tolerated Dose (MTD)
Time frame: Within first 3 weeks of treatment
Phase 1a
Number of Participants with protocol specified Dose Limiting Toxicities (DLTs)
Time frame: Within first 3 weeks of treatment
Phase 1a
Dose recommended for future studies
Time frame: Within first 3 weeks of treatment
Phase 1a/1b
Clinical Laboratory Abnormalities
Time frame: Clinical laboratory abnormalities will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Incidence and severity of clinical laboratory abnormalities in serum chemistry, hematology, coagulation parameters, and urinalysis tests as assessed by CTCAE v5.0 (Phase 1a/1b)
Adverse Event Parameters
Time frame: Adverse Event Parameters will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Incidence and severity of adverse events as assessed by CTCAE v5.0 (Phase 1a/1b)
ECG Parameters
Time frame: ECG Parameters will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Changes in the ECG parameters, including heart rate and measures PR, QRS, QT, and QTc intervals as assessed by CTCAE v5.0 Phase 1a/1b
10 secondary outcomes
Area under the plasma concentration versus time curve for KT-413 from time zero to last quantifiable time point (AUC0-t)
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Maximum Plasma Concentration of KT-413 (Cmax)
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Time of maximum plasma concentration of KT-413 (Tmax)
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Half-life of KT-413 [if data permits (T1/2)]
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 21 days)
Amount of KT-413 excreted in urine from time zero to last collected timepoint (Ae0-t)
Time frame: Urine samples for PK analysis collected during the first cycle (21 day cycle)
Evidence of clinical activity of KT-413 as determined by Objective Response Rate (ORR)
Time frame: From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Duration of Response (DOR) as assessed by the Investigator
Time frame: From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Progression-free survival (PFS) as assessed by the Investigator
Time frame: From time of entry on study through progression, up to 18 months
Disease Control Rate (DCR) as assessed by the investigator
Time frame: From date of baseline scan until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Overall Survival (OS) as assessed by the investigator
Time frame: From time of entry on study through death or date last known alive at end of follow-up, up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashwin Gollerkeri, MD study director
Kymera Therapeutics, Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KT-413 in people with Non Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by Kymera Therapeutics, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the Maximum Tolerated Dose (MTD) (time frame: Within first 3 weeks of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.