Several clinical trials are investigating indications across Lyme disease, diffuse large B-cell lymphoma and other B-cell malignancies, cardiometabolic conditions including diabetes and hypertension, and osteogenesis imperfecta. Ranging from early-phase interventional studies (Phase 1 and Phase 1/Phase 2) to observational and unassigned classifications, these protocols are currently either actively recruiting or not yet recruiting participants. Trial sponsors include academic institutions, university health networks, government entities, and biotechnology companies such as Poseida Therapeutics and Roche-Genentech.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06045416 | Not yet recruiting | Lyme Disease|Borrelia Infections |
University Children''s Hospital Zurich|Institute of Medical Microbiology University of Zurich Zurich Switzerland |
2024-04-01 | -- |
| NCT06003179 | Not yet recruiting | Lymphoma Large B-Cell Diffuse |
University Health Network Toronto |
2024-04 | Phase 1 |
| NCT06014762 | Recruiting | Diffuse Large B Cell Lymphoma|Follicular Lymphoma|Mantle Cell Lymphoma|Marginal Zone Lymphoma|Primary Mediastinal Large B-cell Lymphoma (PMBCL)|Chronic Lymphocytic Leukemia |
Poseida Therapeutics Inc.|Roche-Genentech |
2024-04 | Phase 1 |
| NCT06358859 | Not yet recruiting | Cardiometabolic Risk Factors|Diabetes|High Blood Pressure|Obesity|Nutrition Security |
Tufts University|National Institute on Minority Health and Health Disparities (NIMHD)|Tougaloo College Mississippi|Delta Health Center Mississippi|Reuben V. Anderson Center for Justice at Tougaloo |
2024-04 | Not Applicable |
| NCT05559801 | Not yet recruiting | Osteogenesis Imperfecta|Osteogenesis Imperfecta Type III |
Emory University |
2024-04 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).