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Autologous hematopoietic stem cells (aHSCs) infused on Day 10 after CAR T (any FDA-approved CAR T product) infusion on Day 0.

autologous hematopoietic stem cells added to planned CAR T

Clinical Trial Recruitment Navigator

John Chute, MD

Justin Darrah, MD

Noah Merin, MD, PhD

Ronald Paquette, MD

Robert Vescio, MD

Hannah Lee, MD

Akil Merchant, MD

David Oveisi, MD

Leslie Ballas, MD

Joshua Sasine, MD, PhD

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.

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

IIT2022-04-Sasine-CAR-T: A Phase 1 Single-arm, Open-label Study to Evaluate the 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

Target dose collection of autologous HSCs (2 to 5 x 106 CD34+ cells/kg) defined as collection from at least 50% of patients enrolled in this study by Day 10.

Safety will be assessed by incidence, severity, and duration of CRS per ASTCT consensus grading system. ASTCT CRS Consensus grading (Grade scale is 1-4) is based on 3 CRS parameters: fever, hypotension, and hypoxia. Higher grade indicates worse outcome.

Safety will be assessed by incidence, severity, and duration ICANS per ASTCT consensus grading system. ASTCT ICANS Consensus grading (Grade scale is 1-4) is based on 5 neurotoxicity domains: Immune Effector Cell-Associated Encephalopathy (ICE) score, level of consciousness, seizure, motor findings, raised intracranial pressure (ICP)/cerebral edema. Higher grade indicates worse outcome.

Response rate of CAR T will be defined as the proportion of subjects who experience partial response (PR) or complete response (CR) assessed at 6 weeks or day 60. Response criteria used will be according to type of disease: Response by International Myeloma Working Group (IMWG) Criteria (for multiple myeloma); Response by Center for International Blood and Marrow Transplant Research (CIMBTR) Criteria (for acute lymphoblastic leukemia); Response by Lugano Criterial (for lymphoma).

Recovery assessed by the proportion of patients with ANC recover to ≥ 500/µL.

The proportion of patients with RBC transfusion independence by Day 28.

The proportion of patients with platelet transfusion independence by Day 28.

Safety and tolerability will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs) related to study treatment according to CTCAE v.5, up to Week 52.

PFS will be assessed from time of CAR T infusion until confirmation of disease progression or withdrawal of consent, whichever comes first.

OS will be assessed from date of CAR T infusion until date of death due to any cause or withdrawal of consent, whichever comes first.

Assistant Professor of Medicine, Co-Director, CAR T Program

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT05887167	Hematologic Mal... Large B-cell Ly... Acute Lymphobla... Mantle Cell Lym... Multiple Myelom... Diffuse Large B...	autologous hema...	18 Years - 85 Years	Cedars-Sinai Medical Center
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	NCT05887167	Hematologic Mal... Large B-cell Ly... Acute Lymphobla... Mantle Cell Lym... Multiple Myelom... Diffuse Large B...	autologous hema...	18 Years - 85 Years	Cedars-Sinai Medical Center

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