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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Joshua Sasine, MD, PhD
Study ID
NCT05887167
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • autologous hematopoietic stem cells added to planned CAR T — BIOLOGICAL
    Autologous hematopoietic stem cells (aHSCs) infused on Day 10 after CAR T (any FDA-approved CAR T product) infusion on Day 0.

Study Details

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.

Key Dates

Start date
Mar 2, 2024
Status verified
May 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CAR T Therapy with Autologous Hematopoietic Stem Cells (aHSCs)

Primary Outcome Measure

To assess feasibility of collecting the target HSC cell dose for at least 50% of enrolled patients. [ Time Frame: From Day 0 (CAR T infusion) to Day 10 (aHSC infusion). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
310-423-2133
John Chute, MD (SUB_INVESTIGATOR)
Justin Darrah, MD (SUB_INVESTIGATOR)
Noah Merin, MD, PhD (SUB_INVESTIGATOR)
Ronald Paquette, MD (SUB_INVESTIGATOR)
Robert Vescio, MD (SUB_INVESTIGATOR)
Hannah Lee, MD (SUB_INVESTIGATOR)
Akil Merchant, MD (SUB_INVESTIGATOR)
David Oveisi, MD (SUB_INVESTIGATOR)
Leslie Ballas, MD (SUB_INVESTIGATOR)

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