Hematologic MalignancyPhase 1NCT05887167
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
A Phase 1 study testing autologous hematopoietic stem cells added to planned CAR T in people with Hematologic Malignancy and Large B-cell Lymphoma, run by Joshua Sasine, MD, PhD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hematologic Malignancy, Large B-cell Lymphoma, Acute Lymphoblastic Leukemia
- What is being tested?
- autologous hematopoietic stem cells added to planned CAR T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2024to 15 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
John Chute, MD
About this study
Official title: 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
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
- Hematologic Malignancy, Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma, Diffuse Large B Cell Lymphoma
- Being tested
- autologous hematopoietic stem cells added to planned CAR T
- Keywords
- CAR T-cell therapy, autologous hematopoietic stem cells, CAR T, CAR T therapy
- Medical subject headings
- Hematologic Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Mantle-Cell, Multiple Myeloma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous hematopoietic stem cells added to planned CAR TBiological
Autologous hematopoietic stem cells (aHSCs) infused on Day 10 after CAR T (any FDA-approved CAR T product) infusion on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| CAR T Therapy with Autologous Hematopoietic Stem Cells (aHSCs) | Experimental | Not described Receives: Biological: autologous hematopoietic stem cells added to planned CAR T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess feasibility of collecting the target HSC cell dose for at least 50% of enrolled patients.
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.
Measured: From Day 0 (CAR T infusion) to Day 10 (aHSC infusion).
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.
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.
Measured: From Day 0 to Day 60.
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.
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.
Measured: From Day 0 to Day 60.
Secondary outcomes (7)
Response rate of CAR T at 6 weeks.
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).
Measured: From Day 0 to Day 60.
Assess rate of recovery of absolute neutrophil count (ANC) by Day 28.
Recovery assessed by the proportion of patients with ANC recover to ≥ 500/µL.
Measured: From Day 0 to Day 28.
Assess red blood cell (RBC) count and transfusion independence by Day 28.
The proportion of patients with RBC transfusion independence by Day 28.
Measured: From Day 0 to Day 28.
Assess platelet count and transfusion independence rate by Day 28.
The proportion of patients with platelet transfusion independence by Day 28.
Measured: From Day 0 to Day 28.
Assess safety and tolerability of combining aHSCs with an FDA-approved CAR T regimen within first 52 weeks of aHSC infusion.
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.
Measured: From Day 0 to Week 52.
Median progression-free survival (PFS) for the duration of the study
PFS will be assessed from time of CAR T infusion until confirmation of disease progression or withdrawal of consent, whichever comes first.
Measured: From Day 0 until disease progression or withdrawal. Assessed up to 3 years.
Median overall survival (OS) for the duration of the study
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.
Measured: From Day 0 until death due to any cause or withdrawal of consent. Assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start2 Mar 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Sasine, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Sasine, MD, PhD, Cedars-Sinai Medical Center
- Investigators
- Joshua Sasine, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887167
- Sponsor's protocol ID
- IIT2022-04-Sasine-CAR-T
- Status last verified
- Aug 2026
- First submitted
- 17 May 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05887167
- Acronym / sponsor ID
- IIT2022-04-Sasine-CAR-T
- Conditions
- Hematologic Malignancy, Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma, Diffuse Large B Cell Lymphoma
- Keywords
- CAR T-cell therapy, autologous hematopoietic stem cells, CAR T, CAR T therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Joshua Sasine, MD, PhDUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR T Therapy with Autologous Hematopoietic Stem Cells (aHSCs) | Experimental | Biological: autologous hematopoietic stem cells added to planned CAR T |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous hematopoietic stem cells added to planned CAR TAutologous hematopoietic stem cells (aHSCs) infused on Day 10 after CAR T (any FDA-approved CAR T product) infusion on Day 0. | Biological | CAR T Therapy with Autologous Hematopoietic Stem Cells (aHSCs) |
Primary outcome
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).
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.
Time frame: 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.
Time frame: 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.
7 secondary outcomes
Response rate of CAR T at 6 weeks.
Time frame: From Day 0 to Day 60.
Assess rate of recovery of absolute neutrophil count (ANC) by Day 28.
Time frame: From Day 0 to Day 28.
Assess red blood cell (RBC) count and transfusion independence by Day 28.
Time frame: From Day 0 to Day 28.
Assess platelet count and transfusion independence rate by Day 28.
Time frame: From Day 0 to Day 28.
Assess safety and tolerability of combining aHSCs with an FDA-approved CAR T regimen within first 52 weeks of aHSC infusion.
Time frame: From Day 0 to Week 52.
Median progression-free survival (PFS) for the duration of the study
Time frame: From Day 0 until disease progression or withdrawal. Assessed up to 3 years.
Median overall survival (OS) for the duration of the study
Time frame: From Day 0 until death due to any cause or withdrawal of consent. Assessed up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Sasine, MD, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous hematopoietic stem cells added to planned CAR T in people with Hematologic Malignancy and Large B-cell Lymphoma, run by Joshua Sasine, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Recruitment Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.