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DRUG CLASS:

Microbiome modulator

2d
StarFish-UC: Confirmatory Clinical Study in Active Ulcerative Colitis (clinicaltrials.gov)
P2, N=204, Recruiting, MRM Health NV | Not yet recruiting --> Recruiting
Enrollment open
3d
New P1/2 trial
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Jakafi (ruxolitinib) • Xervyteg (MaaT013)
5d
A probiotic bacterium modulates antitumour γδ T-cell responses in lung cancer. (PubMed, Front Immunol)
The probiotic Clostridium butyricum strain MIYAIRI 588 (CBM588) improves response rates and overall survival in patients receiving immune checkpoint inhibitor (ICI) therapy for non-small cell lung cancer and metastatic renal cell carcinoma but the mechanism underlying this benefit remains unclear...Across the patient cohort, higher post-treatment frequencies of CD69+ Vδ2 T-cells were associated with improved survival and more favourable clinical outcomes. These findings provide a potential mechanism by which manipulation of the intestinal microflora might contribute to cancer prognosis through effects on immune effector cells with intrinsic anticancer properties.
Journal • IO biomarker
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CD69 (CD69 Molecule)
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Cdactin-O (CBM588)
6d
Enrollment closed • Trial initiation date
8d
KAN-004 for Immune-Related Diarrhea or Colitis (clinicaltrials.gov)
P1, N=21, Recruiting, Centre hospitalier de l'Université de Montréal (CHUM) | Initiation date: Oct 2025 --> Mar 2026 | Not yet recruiting --> Recruiting
Enrollment open • Trial initiation date
13d
RESIST-PTSD: Microbiome Modulation With Prebiotics in PTSD and Cirrhosis (clinicaltrials.gov)
P=N/A, N=30, Recruiting, Hunter Holmes Mcguire Veteran Affairs Medical Center | Trial completion date: Sep 2025 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Jun 2027
Trial completion date • Trial primary completion date
15d
MIYAIRI 588: CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant (clinicaltrials.gov)
P1, N=36, Active, not recruiting, City of Hope Medical Center | Trial completion date: Mar 2026 --> Feb 2027 | Trial primary completion date: Mar 2026 --> Feb 2027
Trial completion date • Trial primary completion date
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Cdactin-O (CBM588)
19d
Enrollment open
|
Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • MaaT033 • Navelbine oral (vinorelbine tartrate oral)
1m
SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov)
P1/2, N=36, Active, not recruiting, Theriva Biologics, Inc. | Trial completion date: Dec 2026 --> Sep 2030 | Trial primary completion date: Dec 2025 --> Sep 2029
Trial completion date • Trial primary completion date
1m
Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis (clinicaltrials.gov)
P2, N=58, Recruiting, The University of Texas Health Science Center, Houston | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date