Limiting antibiotics during CAR-T therapy for lymphoma or myeloma to protect gut bacteria
Tests a restricted antibiotic approach in adults receiving CAR-T therapy for lymphoma or myeloma.
Plain-language title generated from the registry record
Registry title: Restrictive Versus Standard Antibiotic Treatment During CAR-T Therapy
Key facts
- Where
- Roskilde, DenmarkSee the site
- Phase
- Phase 2
Where in Denmark
- Zealand University HospitalRoskilde, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zealand University Hospital
- Trial code
- NCT07842198
- Record updated
- 25 September 2026
- Original description
The purpose of the CARMic study is to investigate whether a restrictive, microbiome-sparing antibiotic strategy can better preserve the gut microbiota in patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy without compromising infectious safety.Read full original descriptionShow less
Gut Microbiota in Patients With Haematological Malignancies Undergoing CAR-T Cell Therapy: A Randomized Phase II Trial Comparing Standard of Care Versus a Restrictive Antibiotic Strategy
The purpose of the CARMic study is to investigate whether a restrictive, microbiome-sparing antibiotic strategy can better preserve the gut microbiota in patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy without compromising infectious safety.
This is a randomized, open-label Phase II trial enrolling 150 adults with large B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care CAR-T therapy. Participants will be randomly assigned in a 1:1 ratio to either a restrictive antibiotic strategy based on ceftazidime and/or ciprofloxacin or an unrestricted standard-of-care antibiotic strategy. The assigned strategy will apply from randomization until 28 days after CAR-T-cell infusion. Antibiotic treatment may be modified or broadened at any time when clinically indicated.
The primary question is whether the restrictive antibiotic strategy results in greater gut microbial diversity 28 days after CAR-T-cell infusion compared with standard-of-care antibiotic treatment. Gut microbial diversity will be assessed in stool samples using the Shannon diversity index.
The study will also compare infections, antibiotic exposure, adherence to the assigned strategy, CAR-T-related toxicities, treatment response, relapse, progression-free survival, and overall survival between the two groups. Changes in gut microbiota composition and in blood and stool metabolomic and proteomic profiles will be evaluated over time. Blood and stool samples will be collected at randomization, around the time of CAR-T-cell infusion, 28 days after infusion, and at the end-of-treatment evaluation approximately 3-6 months after infusion.
Inclusion: Age 18 years or older. Relapsed or refractory large B-cell lymphoma according to the current World Health Organization classification, or relapsed or refractory multiple myeloma according to the current International Myeloma Working Group classification; Eligible for treatment with a CAR-T-cell product authorized in the European Union and recommended for reimbursement by the Danish Medicines Council; A clinical decision to proceed with CAR-T-cell therapy has been made jointly by the participant and the treating physician; Written informed consent to participate in the trial.
Exclusion: Clinical signs of an uncontrolled serious infection. Severe colitis. Previous allergic reaction to cephalosporins or ciprofloxacin. Participants with a known allergy to other beta-lactam antibiotics, including penicillins, may be enrolled provided that they do not have a known allergy to cephalosporins; Pregnancy or breastfeeding. Psychiatric illness or other condition that may interfere with the ability to understand or comply with the trial requirements.