A Phase 1 interventional study of KT-333 in Non Hodgkin Lymphoma (NHL), Peripheral T-cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL), sponsored by Kymera Therapeutics, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Kymera Therapeutics, Inc. · Phase 1, Interventional, and Treatment
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or Refractory (R/R) Lymphomas, Large Granular Lymphocytic Leukemia (LGL-L), T-cell prolymphocytic leukemia (T-PLL), and Solid Tumors. The Phase 1a stage of the study will explore escalating doses of single-agent KT-333. The Phase Ib stage will consist of 4 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Peripheral T-cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), LGL-L, and solid tumors.
This is an open-label Phase 1a (dose escalation)/1b (dose expansion) first-in-human study of KT-333 in adult patients. Patients with relapsed/refractory (R/R) lymphomas, LGL-L, T-PLL, and solid tumors will be enrolled in Phase 1a. Phase 1b will consist of separate cohorts of patients with R/R PTCL, CTCL, LGL-L, and solid tumors.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 56 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Kymera Therapeutics, Inc. is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
LGL-L patients only (hematology specific criteria):
One of the following:
LGL-L Patients Only (baseline disease characteristics):
Exclusion Criteria:
Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
Note: Patients with solid tumors are eligible if their CNS metastases or cord compression have been treated (e.g., radiotherapy, stereotactic surgery) and they are clinically stable, off steroids for at least 4 weeks before first dose of study drug and have no evidence of progression at time of study enrollment.
Note: Patients with lymphomas are eligible if their CNS metastases or cord compression have been treated effectively (i.e. achieved CR) and there is no clinical or radiographic evidence of active lymphoma.
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 dosed IV weekly in 28 day cycles
Drug: KT-333
KT-333 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined frequency and dose level.
Safety
Incidence and severity of adverse events as assessed by CTCAE v5.0 Phase 1a/1b
Time frame: Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Safety
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
Time frame: Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Safety
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
Time frame: Safety will be assessed from the time ICF signature through 30 days post dose or prior to start of a new anticancer therapy
Maximum Tolerated Dose (MTD)
To establish the Maximum Tolerated Dose (MTD) Phase 1a
Time frame: Within the first 28 days of treatment
Dose Limiting Toxicities (DLTs)
Number of Participants with protocol specified Dose Limiting Toxicities (DLTs) Phase 1a
Time frame: Within the first 28days of treatment
Area under the plasma concentration versus time curve for KT-333
Area under the plasma concentration versus time curve for KT-333 from time to zero to last quantifiable time point (AUC 0-t ) Phase 1a/1b
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Maximum Plasma Concentration of KT-333 (Cmax)
Maximum Plasma Concentration of KT-333 (Cmax)
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Time of maximum plasma concentration of KT-333 (Tmax)
Time of maximum plasma concentration of KT-333 (Tmax) Phase 1a/1b
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Half-life of KT-333 if data permits (T1/2)
Half-life of KT-333 if data permits (T1/2) Phase 1a/1b
Time frame: Blood samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Amount of KT-333 dose excreted in urine from time zero to last collected time point (Ae0-t)
Amount of KT-333 dose excreted in urine from time zero to last collected time point (Ae0-t) Phase 1a
Time frame: Urine samples for PK analysis collected at multiple visits during cycle 1 and cycle 2 (each cycle is 28days)
Evidence of clinical activity of KT-333
Evidence of clinical activity of KT-333 as determined by Objective Response Rate (ORR) as per Lugano criteria 2014 for Lymphomas Phase 1a/1b.
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
Evidence of clinical activity of KT-333
Evidence of clinical activity of KT-333 as determined by RECIST 1.1 to determine ORR , complete response (CR), partial response (PR) for solid tumors Phase 1a/1b.
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
Evidence of clinical activity of KT-333
Evidence of clinical activity of KT-333 as determined by ORR by Modified Severity-Weighted Assessment Tool (mSWAT) for Cutaneous T-Cell Lymphoma (CTCL) Phase 1a/1b
Time frame: Composite assessment from date of baseline assessment until the date of first documented progression or date of death from any cause, whichever came first, about 18 months
Evidence of clinical activity of KT-333
Evidence of clinical activity of KT-333 as determined by ORR by investigator assessment for Large Granular Lymphocytic Leukemia (LGL-L) Phase 1a/1b
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
Evidence of clinical activity of KT-333
Evidence of clinical activity of KT-333 as determined by ORR based on T-PLL International Study Group criteria, Phase 1a
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)
Duration of Response (DOR) Phase 1a/1b
Time frame: From date of first of response to the date of documented first progression or death whichever comes first, about 18 months
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Kymera Therapeutics, Inc.