Actively Recruiting

Phase 1
Age: 18Years - 85Years
All Genders
NCT05887167

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

Led by Joshua Sasine, MD, PhD · Updated on 2026-05-07

20

Participants Needed

1

Research Sites

197 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 85 years
  • Histologically confirmed hematological malignancy with an FDA-approved CAR T product available
  • Relapsed or refractory disease, defined as disease progression after last treatment or failure to achieve partial or complete remission
  • At least 2 weeks or 5 half-lives since prior systemic therapy before leukapheresis
  • Stable or recovered toxicities from prior therapy to Grade 1 or less, except alopecia
  • No active uncontrolled infection before starting CAR T therapy
  • ECOG performance status of 0 to 2
  • Adequate blood, liver, and heart function
  • Negative pregnancy test for women of childbearing potential at screening
  • Willingness to comply with research specimen collection
  • Ability to provide written informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Autologous hematopoietic cell transplant planned or done within 8 weeks before CAR T infusion
  • History of allogeneic cell transplant within 8 weeks before CAR T infusion
  • Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infection requiring IV antimicrobials at screening
  • History of major cardiac events or significant heart disease within 6 months before enrollment
  • History of seizure disorder, stroke, dementia, or autoimmune disease affecting the central nervous system
  • Use of corticosteroids ≥5 mg/day prednisone or equivalent and other immunosuppressives without required washout before enrollment
  • Medical conditions interfering with feasibility or safety assessment of study treatment
  • Live vaccine within 6 weeks before starting conditioning regimen
  • History of severe immediate allergic reactions to study agents
  • Current pregnancy or breastfeeding
  • Not willing to use birth control from consent through 6 months after chemotherapy completion (except surgically sterilized or postmenopausal women)
  • Unlikely to complete all study visits or follow-up
  • Presence of myeloid clonal hematopoiesis on screening bone marrow biopsy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

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CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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