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Feasibility and Safety of Autologous Hematopoietic Stem Cells with CAR T-Cell Therapy for Blood Cancers

This study is looking at a new way to treat certain blood cancers like lymphoma and leukemia that have come back or are not responding to treatment. It combines your own stem cells (autologous hematopoietic stem cells) with an existing CAR T-cell therapy. Researchers want to see if it's possible to collect enough of your stem cells and if adding them to CAR T-cell therapy is safe. They will be watching for side effects like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days. This study is for adults aged 18 to 85 with specific types of relapsed or refractory blood cancers. The goal is to enroll 20 patients.

Study design
This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It is a single-center study, not randomized, and plans to include 20 participants.
What's involved
You will receive CAR T-cell therapy on Day 0, followed by an infusion of your own stem cells on Day 10. Your safety will be monitored for at least 60 days after the CAR T infusion.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be assessed for the first 60 days after CAR T-cell therapy infusion.

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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

Recruiting
PHASE1Ages 18–85InterventionalTreatment
Joshua Sasine, MD, PhD
~20 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:autologous hematopoietic stem cells added to planned CAR T

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess feasibility of collecting the target HSC cell dose for at least 50% of enrolled patients.
Measured over From Day 0 (CAR T infusion) to Day 10 (aHSC infusion).
+2 more outcomes measured

Conditions

Hematologic Malignancy
Large B-cell Lymphoma
Acute Lymphoblastic Leukemia
Mantle Cell Lymphoma
Multiple Myeloma
Diffuse Large B Cell Lymphoma

Explore related trials

Acute Lymphoblastic LeukemiaDiffuse Large B-Cell LymphomaLarge B-cell lymphomaMalignant neoplasm of lymphoid, hematopoietic and/or related tissueMantle Cell LymphomaMultiple Myeloma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Joshua Sasine, MD, PhD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Recruitment Navigator
[email protected]
310-423-5842
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 - 85 years.
Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially available, FDA-approved CAR T product exists.
Relapsed or refractory disease, defined by the following:
Disease progression after last regimen, or
Refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy for the malignancy at the time the subject is planned for leukapheresis.
Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 with the exception of alopecia.
Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved.
Eastern cooperative oncology group (ECOG) performance status 0 - 2.
Adequate hematologic, hepatic, and cardiac function
Serum pregnancy test for women of childbearing potential (WOCBP) at Screening.
Willing to comply to research specimen collection as specified in the protocol.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion

Autologous hematopoietic cell transplant intent or execution within 8 weeks of planned CAR T infusion.
History of allogeneic cell transplantation within 8 weeks of planned CAR T infusion.
Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management at time of screening.
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.
History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, or any autoimmune disease with CNS involvement.
Doses of corticosteroids of greater than or equal to 5 mg/day of prednisone or equivalent doses of other corticosteroids and other immunosuppressive drugs are not allowed prior to enrollment. A washout period of 10 days prior to leukapheresis and 10 days prior to anti-CD19 CAR T cell administration is required.
Any medical condition likely to interfere with assessment of feasibility or safety of study treatment.
Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.
History of severe immediate hypersensitivity reaction to any of the agents used in this study.
Current pregnancy or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
Subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy. Females who have undergone surgical sterilization or who have been postmenopausal for at least 1 year are not considered to be of childbearing potential.
In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
Patients with obvious myeloid clonal hematopoiesis on the screening bone marrow biopsy will be excluded based on the risk of developing myeloid neoplasms with aHSC infusion.

What this trial measures

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

    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.

  • To assess safety of aHSC to planned CAR T therapy in the first 60 days through the incidence, severity, and duration of CRS based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system.From Day 0 to Day 60.

    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.

  • To assess safety of aHSC to planned CAR T therapy in the first 60 days through the incidence, severity, and duration of ICANS based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system.From Day 0 to Day 60.

    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.