Multiple clinical trials evaluate manganese chloride across several oncological indications, including solid tumors, lymphoma, biliary tract cancer, ovarian cancer, and pancreatic cancer. Primarily Phase 1 and Phase 2 investigations sponsored by the Chinese PLA General Hospital, these studies assess safety, tolerability, and preliminary therapeutic efficacy in monotherapy and combination regimens. With recruitment statuses ranging from completed to unknown, these trials reflect the ongoing early-to-mid-stage development of manganese-based immunotherapy protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04873440 | UNKNOWN | Solid Tumor; Lymphoma |
Chinese PLA General Hospital |
2021-05-06 | PHASE1; PHASE2 |
| NCT03989336 | COMPLETED | Ovarian Cancer |
Chinese PLA General Hospital |
2020-12-23 | PHASE2 |
| NCT03989310 | UNKNOWN | Pancreatic Cancer |
Chinese PLA General Hospital |
2019-03-01 | PHASE1; PHASE2 |
| NCT04004234 | UNKNOWN | Biliary Tract Cancer (BTC) |
Chinese PLA General Hospital |
2019-03-01 | PHASE1; PHASE2 |
| NCT03991559 | UNKNOWN | Solid Tumor; Lymphoma |
Chinese PLA General Hospital |
2018-11-01 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2021-05-05)
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>).