Can gut bacteria make CAR-T therapy safer and stronger?
NCT ID NCT07871747
First seen Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time
Summary
CAR-T cell therapy helps many people with large B-cell lymphoma and multiple myeloma, but the benefits do not always last and side effects can be severe. Researchers at the University of Chicago are testing an oral product made of live gut bacteria, chosen because they produce butyrate, as an add-on to standard CAR-T treatment. The Phase 1 trial enrolls 32 adults with these cancers who are already scheduled to receive commercial CAR-T therapy. The main goal is to see whether the bacterial product is safe and tolerable, and whether the bacteria take up residence in the gut.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an oral live bacterial consortium designed to produce butyrate
- What this could lead to
- If it works, gut bacteria could become a routine add-on that makes CAR-T therapy last longer and cause fewer severe side effects. That could help more people with lymphoma and multiple myeloma get lasting benefit from treatment.
- What could go wrong
- This is a small Phase 1 trial with 32 people, so its main job is checking safety, not proving the bacteria help. The approach may fail to take hold in the gut, or the results may not hold up in larger studies.
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 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
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 years and older
- 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: * Patients with a histologically confirmed Large B-Cell Lymphoma (LBCL) or Multiple Myeloma (MM) who are to receive a commercial Chimeric Antigen Receptor T-Cell (CAR-T) product per individual investigator. * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%). * Patient meets the eligibility criteria for the commercial CAR-T product they will receive (axi-cel, liso-cel, or cilta-cel), including the organ function, hematologic, and cardiopulmonary thresholds specified by institutional standard-of-care eligibility for CAR-T administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who are receiving any other investigational agents. * Inability to swallow capsules. * Patients with known intestinal barrier dysfunction, including clinically active IBD (Crohn's or ulcerative colitis), GI bleed, enteropathy (including celiac disease), ischemic colitis, microscopic colitis, graft versus host disease, or malignant involvement of GI tract. * History of behavioral disorders, including substance abuse disorders, which, in the discretion of the primary investigator, will interfere with safe conduct and compliance with study treatment. * Diagnosis of primary immunodeficiency. * Active second malignancy requiring treatment except non-melanoma skin cancer or carcinoma in situ of the cervix, bladder, or non-metastatic prostate cancer which does not require treatment. * Active treatment (within 24 hours of LBP administration) for a bacterial, fungal, or viral infection confirmed using clinical, laboratory, and radiographic findings. Prophylactic antivirals, anti-fungals, and anti-bacterial (levofloxacin, cefdinir, and trimethoprim-sulfamethoxazole) are allowed. * Any clinical, laboratory, or radiologic findings, at the discretion of the primary investigator, will interfere with the safe conduct of study treatment and compliance with study procedures. * Documented severe hypersensitivity reaction (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS) precluding safe administration of all four of the following antibiotics: ampicillin/sulbactam, piperacillin/tazobactam, metronidazole, and meropenem. These four agents have confirmed in vitro activity against every strain in the consortium; concurrent contraindication to all four would preclude empiric antibiotic coverage in the unlikely event of bacteremia from a consortium organism. Self-reported drug intolerance (e.g., nausea, headache, non-specific rash without systemic features) does not meet this criterion; ambiguous allergy histories should be reviewed with the Sponsor-Investigator and, when feasible, evaluated by an allergist for de-labeling prior to exclusion. * History of allergic reactions attributed to any of the investigational products or components. * Ileostomy, colostomy, or resection of over 50% of the large bowel. * Pregnant or breastfeeding women.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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