KT-333 for Lymphoma and Cancer

Recruiting at 12 trial locations

Overseen By Kymera Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kymera Therapeutics, Inc.

Disqualifiers: CNS metastases, CLL, other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called KT-333 in adults with certain cancers that haven't responded to other treatments. The goal is to see if the drug is safe and how it works in the body.

Research Team

Ashwin Gollerkeri, MD

Principal Investigator

Kymera Therapeutics, Inc.

Eligibility Criteria

Adults with certain types of blood cancers or solid tumors that haven't responded to standard treatments can join this trial. They should have a specific level of white blood cells, be in fair health (ECOG 0-2), and women must use effective birth control. People with brain metastases, another active cancer besides lymphoma or solid tumors, recent transplants, or unresolved treatment side effects are excluded.

Inclusion Criteria

LGL-L Patients with specific baseline disease characteristics

My disease has not responded to at least one standard treatment.

I have LGL leukemia or T-PLL and my previous treatments didn’t work or there are no standard treatments available for me.

Exclusion Criteria

I had a stem cell transplant using my own cells less than 3 months ago.

Patients with prior allogenic hematopoietic or bone marrow transplant

I do not have active, uncontrolled brain metastases or specific types of meningitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose Escalation

Participants receive escalating doses of KT-333 to evaluate safety, tolerability, and pharmacokinetics

28 days per cycle

Weekly visits for IV dosing

Phase 1b Dose Expansion

Participants are divided into cohorts to further evaluate safety and pharmacokinetics of KT-333

28 days per cycle

Weekly visits for IV dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• KT-333

Trial Overview The study is testing KT-333's safety and how the body processes it in two phases: Phase 1a tests increasing doses on various cancers; Phase 1b focuses on Peripheral T-cell Lymphoma, Cutaneous T-Cell Lymphoma, Large Granular Lymphocytic Leukemia, and solid tumors to further understand KT-333's effects.

Participant Groups

Group I: Phase 1b Dose Expansion Solid Tumor Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group II: Phase 1b Dose Expansion PTCL Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group III: Phase 1b Dose Expansion LGL-L Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group IV: Phase 1b Dose Expansion CTCL Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group V: Phase 1a Dose Escalation T-PLL Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group VI: Phase 1a Dose Escalation Solid Tumors Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group VII: Phase 1a Dose Escalation Lymphomas Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group VIII: Phase 1a Dose Escalation LGL-L Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

850+