Stem cells may supercharge CAR t for tough blood cancers
NCT ID NCT05887167
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This early-phase trial is testing whether adding a patient's own blood stem cells to standard CAR T-cell therapy is safe and doable for people with relapsed or refractory blood cancers like lymphoma, leukemia, and myeloma. Twenty participants will receive their own stem cells 10 days after CAR T infusion. The main goals are to see if enough stem cells can be collected and to monitor side effects like cytokine release syndrome and nerve toxicity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous hematopoietic stem cells (aHSCs) combined with FDA-approved CAR T-cell therapy
- What this could lead to
- If successful, this approach could make CAR T therapy safer and more effective for patients with hard-to-treat blood cancers.
- What could go wrong
- This is a very early phase 1 trial with only 20 participants, so results may not apply broadly. Adding stem cells could also increase risks like graft-versus-host disease or other complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas