Recruiting
Phase 1

CAR T-Cell Therapy

Sponsor:

Joshua Sasine, MD, PhD

Code:

NCT05887167

Conditions

Hematologic Malignancy

Large B-cell Lymphoma

Acute Lymphoblastic Leukemia

Mantle Cell Lymphoma

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

autologous hematopoietic stem cells added to planned CAR T

Study Details

Brief 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. 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

Study ID

NCT05887167

Start date

Mar 2, 2024

Status verified date

Aug, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

autologous hematopoietic stem cells added to planned CAR T

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

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). ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

More Information

Sponsor

Joshua Sasine, MD, PhD

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • CAR T-cell therapy
  • autologous hematopoietic stem cells
  • CAR T
  • CAR T therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Joshua Sasine, MD, PhD on 2026-08-10.