Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed/Refractory Hematological Malignancies
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The study is designed to examine the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be combined with CAR T-cell therapy for patients with relapsed/refractory (r/r) hematological disease. The study will evaluate feasibility of collecting the target dose of HSCs from at least 50% of enrolled patients. The study will assess safety based on incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days post CAR T dosing, and also through the collection of adverse events (AEs) and serious adverse events (SAEs) as well as the durability of response after treatment with HSCs with CAR T. The study follows an open-label, single-center and single non-randomized cohort design. 20 subjects with r/r hematological malignancies will be enrolled and treated to evaluate the feasibility and preliminary safety of collecting autologous HSCs and combining them with CAR T-cell therapy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-85 lat
- •Potwierdzony nowotwór krwi, dla którego istnieje zatwierdzone leczenie CAR T
- •Choroba powróciła lub nie reaguje na poprzednie leczenie
- •Przerwa co najmniej 2 tygodnie od ostatniego leczenia przed procedurą poboru komórek
- •Skutki uboczne poprzednich terapii ustabilizowane lub zagojoone
- •Brak niekontrolowanego zakażenia
- •Wystarczająca funkcja serca, wątroby i krwiotwórczego systemu
- •Zgoda na uczestnictwo w badaniu i pobieranie prób krwi
✗ Disqualifies
- •Przeszczep macierzystych komórek krwi przeprowadzony w ostatnich 8 tygodniach
- •Historia przeszczepu od dawcy w ostatnich 8 tygodniach
- •Niekontrolowane zakażenie bakteryjne, wirusowe lub grzybiczne
- •Zawał serca, zabiegi na serce lub niestabilna dusznica w ostatnich 6 miesiącach
- •Zaburzenia napadów, udar mózgu lub choroby autoimmunologiczne systemu nerwowego
- •Przyjmowanie kortykosteroidów w dawce 5 mg na dzień lub wyższej
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Last updated (source)
- August 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Cedars-Sinai Medical Center
Los Angeles, United States
Trial contact
Clinical Trial Recruitment Navigator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/11/2026.
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