Non Hodgkin Lymphoma Clinical Trial

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

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. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.
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.
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

Exclusion Criteria:

Known CNS lymphoma or meningeal involvement.
History of or active concurrent malignancy other than B-cell NHL or DLBCL unless the patient has been disease-free for ≥ 2 years. Exceptions to the ≥ 2-year time limit include treated basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.
Infection with hepatitis B (HBV), hepatitis C (HCV), or known history of or current 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05233033

Recruitment Status:

Recruiting

Sponsor:

Kymera Therapeutics, Inc.

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There are 6 Locations for this study

See Locations Near You

MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States More Info
Monica Rengifo Pardo
Contact
202-687-6957
[email protected]
Norton Cancer Institute
Louisville Kentucky, 40207, United States More Info
Don Stevens
Contact
502-899-3366
[email protected]
Henry Ford Health System
Detroit Michigan, 48202, United States More Info
Cesar Figueras, RN
Contact
313-556-8731
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Jennifer Lue, MD
Contact
646-608-4160
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Chizobam Obi
Contact
713-794-3074
[email protected]
University of Virginia Comprehensive Cancer Center
Charlottesville Virginia, 22903, United States More Info
Erica Stallard
Contact
434-243-2649
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05233033

Recruitment Status:

Recruiting

Sponsor:


Kymera Therapeutics, Inc.

How clear is this clinincal trial information?

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