Lymphoma, B-CellPhase 1(MICRO-CART)NCT07871747
Microbiome Intervention for CAR-T Optimization and Response (MICRO-CART)
A Phase 1 study testing Live Biotherapeutic Product (LBP) in people with Lymphoma, B-Cell and Multiple Myeloma, run by University of Chicago at 1 site in United States.
Trial summary
Chimeric Antigen Receptor T-Cell (CAR-T) therapy has transformed the management of large B-cell lymphoma, and multiple myeloma by achieving remarkable responses, yet inconsistent durability and severe toxicities remain major challenges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, Multiple Myeloma
- What is being tested?
- Live Biotherapeutic Product (LBP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2027to 10 Sep 2030
- Phase
- Phase 1
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
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
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
Official title: Merging Strategy That Uses Gut Microbiome Profiling and Targeted Modulation to Improve CAR-T Cell Therapy Outcomes, Predict Responses, and Reduce Toxicity
Chimeric Antigen Receptor T-Cell (CAR-T) therapy has transformed the management of large B-cell lymphoma, and multiple myeloma by achieving remarkable responses, yet inconsistent durability and severe toxicities remain major challenges. To bridge this gap, this Phase 1 trial evaluates the safety and tolerability of a cGMP-compliant oral Live Biotherapeutic Product (LBP) consortium, selected for its capacity to produce butyrate, as an adjunct to standard Chimeric Antigen Receptor T-Cell CAR-T therapy, aiming to restore microbiome function, and potentially improve clinical outcomes.
- Conditions
- Lymphoma, B-Cell, Multiple Myeloma
- Being tested
- Live Biotherapeutic Product (LBP), Placebo
- Medical subject headings
- Lymphoma, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Biotherapeutic Product (LBP)Drug
A Current Good Manufacturing Practice (cGMP) compliant oral bacterial consortium.
PlaceboDrug
A drug product manufactured to match the active Drug Product in appearance, composition, and packaging, but it does not contain the active ingredient (i.e., live bacterial organism).
| Study group | Role | What they receive |
|---|---|---|
| Live Biotherapeutic Product (LBP) + Chimeric Antigen Receptor T-Cell (CAR-T) n=16 | Active comparator | Patients receive CAR-T cell therapy plus targeted gut microbiota modulation. Receives: Drug: Live Biotherapeutic Product (LBP) |
| Chimeric Antigen Receptor T-Cell (CAR-T) + placebo, n=16 | Active comparator | Patients receive CAR-T cell therapy without microbiome intervention, serving as the control for comparison. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety and tolerability
Incidence and severity of adverse events Common Terminology Criteria for Adverse Events (CTCAE v5.0) and American Society for Transplantation and Cellular Therapy (ASTCT 2019).
Measured: 24 months from 1st dose of LBP/Placebo
Secondary outcomes (2)
Assess engraftment of Live Biotherapeutic Product (LBP)
The proportion of LBP-treated patients will be reported with detectable engraftment of at least one consortium strain at each post-dosing timepoint, with exact 95% Clopper-Pearson confidence intervals.
Measured: 12 months after the last patient completes the 30-day dosing window
Assess engraftment of Fecal diversity
Analyses will include the number of consortium strains detected per patient at each timepoint will confirm that detected strains in the LBP arm reflect administered organisms rather than endogenous colonization
Measured: 12 months after the last patient completes the 30-day dosing window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start23 Feb 2027 (estimated)
- Primary completion10 Sep 2030 (estimated)
- Study completion10 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Kline, MD, Principal investigator, University of Chicago Medicine Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871747
- Sponsor's protocol ID
- IRB26-1042
- Acronym
- (MICRO-CART)
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No