Table 3.
Genetically modified microorganisms in different clinical trial stages.
| Condition | Engineered microorganisms | Target | Clinical trial code | Clinical trial phase | Status |
|---|---|---|---|---|---|
| Metabolic diseases | E. coli (SYNB1934 and SYNB1618) | Phenylketonuria | NCT04984525 | Phase 1 | Ongoing |
| Metabolic diseases | E. coli (SYNB8802) | Enteric hyperoxaluria | NCT04629170 | Phase 1 | Ongoing |
| Cancer | E. coli (SYNB1891) | Metastatic solid Neoplasm and Lymphoma | NCT04167137 | Phase 1 | Ongoing |
| Cancer | B. longum (bacTRL-IL-12) | Solid tumors | NCT04025307 | Phase 1 | Ongoing |
| Metabolic diseases | E. coli (SYNB1618) | Phenylketonuria | NCT03516487 | Phase 1/2a | Ongoing |
| Metabolic diseases | Bacteroides (NB1000S) | Enteric hyperoxaluria | NCT04909723 | Phase 1/2a | Ongoing |
| Cancer | B. longum (APS001F) | Solid tumor | NCT01562626 | Phase 1/2 | Ongoing |
| Cancer | B. animalis lactis (EDP1503) | Colorectal cancer and checkpoint inhibitor relapsed tumors | NCT03775850 | Phase 1/2 | Done |
| Disease | L. lactis (AG011) | Moderately active ulcerative colitis | NCT00729872 | Phase 1/2 | Done |
| Metabolic diseases | E. coli (SYNB1020) | Cirrhosis and hyperammonemia | NCT03447730 | Phase 1/2 | Done |
| Metabolic diseases | L. lactis (AG019) | Type 1 diabetes | NCT03751007 | Phase 1/2 | Ongoing |
| Infection | L. lactis (AG013) | Oral mucositis | NCT03234465 | Phase 2 | Done |
| Infection | L. crispatus (LACTIN-V, Osel, Inc.) | Bacterial vaginosis | NCT02766023 | Phase 2 | Done |
| Infection | L. crispatus (LACTIN-V) | Urinary tract infection | NCT00305227 | Phase 2 | Done |
| Diseases | L. rhamnosus GG (LGG) | Gastroenteritis | NCT01773967 | Phase 2/3 | Done |
| Infection | Salmonella (Vivotif) | S. typhi | STN:103123 | — | License |
| Infection | Vibrio cholerae (Vaxchora) | V. cholerae serogroup O1 | STN:125597 | — | License |
| Cancer | Salmonella (VNP20009) | Cancer neoplasm, neoplasm, metastasis | NCT00004988 | Phase 1 | Done |
| Cancer | Salmonella (VNP20009) | Advanced solid tumors | NCT00006254 | Phase 1 | Done |
| Cancer | IL-2 expressing, attenuated Salmonella typhimurium | Unresectable hepatic metastasis | NCT01099631 | Phase 1 | Ongoing |
| Metabolic diseases | E. coli (SYNB1020) | Urea cycle disorder | NCT03179878 | Phase 1 | Done |
| Cancer | E. coli bacterial minicell (VAX014) | Urothelial carcinoma of the urinary bladder | NCT03854721 | Phase 1 | Ongoing |
| Cancer | Clostridium novyi-NTspores | Malignant neoplasm of breast or digestive organs, etc | NCT03435952 | Phase 1 | Ongoing |
| Cancer | Clostridium novyi-NTspores | Solid tumor malignancies | NCT01924689 | Phase 1 | Done |
| Cancer | Salmonella (VXM01) | Recurrent glioblastoma | NCT03750071 | Phase 1/2 | Ongoing |
| Cancer | Listeria monocytogenes (ADXS31-142 + Pembrolizumab) | Cancer prostate cancer | NCT02325557 | Phase 1/2 | Ongoing |
| Cancer | Listeria monocytogenes (CRS-207) | Pancreatic cancer | NCT03190265 | Phase 2 | Ongoing |
| Infection | E. coli (ACE527) | Diarrhea | NCT03179878 | Phase 1/2 | Done |
| Metabolic diseases | Cutaneous microbiota (STMC-103) | Atopic immunoglobulin e-mediated allergic disorder | NCT03819881 | Phase 1b | Unknown |
| Cancer | MRx0518 + Pembrolizumab | Non-small-cell lung cancer, renal cell carcinoma, melanoma | NCT03637803 | Phase 1/2 | Ongoing |
| Cancer | VE800 + Nivolumab | Metastatic cancer | NCT04208958 | Phase 1/2 | Ongoing |
| Infection | Oral full-spectrum microbiota (CP101) | C. difficile infection recurrence | NCT03110133 | Phase 2 | Done |
| Metabolic diseases | Full spectrum microbiota (FSM) | Autism spectrum disorder, gastrointestinal disorder | NCT03408886 | Phase 2 | Ongoing |
| Disease | DS-01 | Irritable bowel syndrome | NCT04598295 | Phase 2 | Unknown |
| Metabolic diseases | MaaT013 | Gastrointestinal acute graft vs host disease | NCT03359980 | Phase 2 | Done |
| Infection | VE303 | C. difficile infection recurrence | NCT03788434 | Phase 2 | Done |
| Infection | SER-109 (purified Firmicutes spores) | C. difficile infection | NCT03183141 | Phase 3 | Done |
| Infection | RBX2660 | C. difficile infection | NCT03244644 | Phase 3 | Done |
Bifidobacterium animalis: B. animalis; Lactobacillus crispatus: L. crispatus.