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Restrictive Versus Standard Antibiotic Treatment During CAR-T Therapy
Sponsor: Zealand University Hospital
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2027-03-01
Completion Date
2031-12-31
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
ceftazidime
Intravenous ceftazidime will be used as initial empirical antibacterial treatment when clinically indicated during the period from randomization through day 28 after CAR-T-cell infusion. Dosing and renal dose adjustment will follow the applicable product information and local clinical practice. Treatment may be modified or broadened at any time when clinically required.
ciprofloxacin
Oral ciprofloxacin may be used as protocol-defined step-down therapy after adequate infection control and clinical stabilization or as antibacterial prophylaxis when clinically indicated in the absence of suspected ongoing infection. Ciprofloxacin will not be used as initial empirical monotherapy for suspected infection. Dosing and renal dose adjustment will follow the applicable product information and local clinical practice.
Standard-of-Care Antibiotic Strategy
Participants will receive antibacterial prophylaxis and treatment according to unrestricted local standard-of-care practice. Selection, dosing, modification, escalation, and duration of antibacterial treatment will be determined by the treating physician according to clinical findings, microbiological results, and local guidelines.
Locations (1)
Zealand University Hospital
Roskilde, Vælg Venligst Region, Denmark