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Набира участници Фаза 1 NCT07075185

A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Multiple Myeloma in Relapse Myeloma Multiple Multiple Myeloma Progression Neoplasms by Histologic Type Neoplasm Hemostatic Disorders Vascular Disorder Paraproteinemias Blood Protein Disorders Hematologic Disease and Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Disease Gene Therapy

Спонсор: Kelonia Therapeutics, Inc.

Налично на: БГ
Обобщение
The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.
Кой може да участва
Inclusion Criteria: * Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease * Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody * Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1 * Participants must have acceptable laboratory values as defined by the protocol Exclusion Criteria: * Participants must not have known central nervous system (CNS) involvement with myeloma * Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis * Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy * Participants cannot require systemic steroids for any condition
Интервенции
KLN-1010
DRUG
Места на провеждане 7
Австралия (3)
The Royal Prince Alfred
Camperdown , New South Wales
Peter MacCallum Cancer Centre
Melbourne , Victoria
The Alfred Paula Fox Melanoma and Cancer Centre
Melbourne , Victoria
САЩ (4)
Emory University Hospital
Atlanta , Georgia
City of Hope
Duarte , California
Stanford University
Palo Alto , California
Providence Portland Medical Center
Portland , Oregon
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
16.07.2025
Крайна дата
01.05.2042
Регистрационен номер
NCT07075185
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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