Clinical Trials
Several Phase 1 and Phase 1b clinical trials, sponsored by Janssen Research & Development LLC and currently active but not recruiting, are evaluating safimaltib (JNJ-67856633) in patients with hematologic malignancies, specifically non-Hodgkin lymphoma and chronic lymphocytic leukemia. These studies investigate safimaltib both as a monotherapy and in combination regimens with other targeted agents, including ibrutinib. Together, these clinical trials aim to establish the safety, pharmacokinetics, and pharmacodynamics of safimaltib in relapsed or refractory B-cell malignancies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04876092 | Active not recruiting | Leukemia Lymphocytic Chronic B-Cell|Lymphoma Non-Hodgkin |
Janssen Research & Development LLC |
2021-07-28 | Phase 1 |
| NCT04657224 | Active not recruiting | Lymphoma Non-Hodgkin|Chronic Lymphocytic Leukemia |
Janssen Research & Development LLC |
2021-02-25 | Phase 1 |
| NCT03900598 | Active not recruiting | Leukemia Lymphocytic Chronic B-Cell|Lymphoma Non-Hodgkin |
Janssen Research & Development LLC |
2019-04-03 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).