Multiple clinical trials across Phase 1, Phase 1/2, and unallocated phases are evaluating therapeutic candidates and diagnostic protocols for multiple sclerosis, advanced EGFR-mutant non-small cell lung cancer, relapsed or refractory lymphoma, and advanced solid tumors. Sponsored by entities including Innodem Neurosciences and EpimAb Biotherapeutics, these studies range in status from active recruitment to not yet recruiting. Together, they assess novel biomarker tracking technologies as well as targeted bispecific and combination biological regimens across neurodegenerative and oncological pathologies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06283524 | Not yet recruiting | Multiple Sclerosis |
Innodem Neurosciences |
2024-03-18 | -- |
| NCT05661266 | Recruiting | Multiple Sclerosis |
Innodem Neurosciences |
2023-08-16 | -- |
| NCT05498389 | Not yet recruiting | Metastatic Lung Non-Small Cell Carcinoma|Advanced Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8|EGFR Mutation-Related Tumors |
Shanghai EpimAb Biotherapeutics Co. Ltd.|Labcorp Corporation of America Holdings Inc |
2023-06 | Phase 1|Phase 2 |
| NCT05607498 | Recruiting | Advanced/Metastatic Solid Tumors|Relapse/Refractory Lymphoma |
EpimAb Biotherapeutics (Suzhou)Co. Ltd. |
2023-03-01 | Phase 1 |
(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>).