Multiple clinical trials are currently evaluating CC-99282 (golcadomide) across Phase I and Phase II studies for various B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, high-grade B-cell lymphoma, and relapsed or refractory non-Hodgkin lymphoma. Sponsored by pharmaceutical companies and academic entities, these protocols encompass active recruiting, active non-recruiting, and completed statuses. Together, these trials evaluate the safety, pharmacokinetics, and therapeutic efficacy of CC-99282 as a targeted therapy.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05283720 | ACTIVE_NOT_RECRUITING | Non-Hodgkin Lymphoma |
Genmab |
2022-06-14 | PHASE2 |
| NCT06835530 | RECRUITING | Diffuse Large B Cell Non-Hodgkin Lymphoma |
Fondazione Italiana Linfomi - ETS |
2025-04-09 | PHASE2 |
| NCT05169515 | ACTIVE_NOT_RECRUITING | Non-Hodgkin Lymphoma |
Hoffmann-La Roche |
2022-10-26 | PHASE1 |
| NCT04884035 | ACTIVE_NOT_RECRUITING | Lymphoma, B-Cell |
Celgene |
2021-09-15 | PHASE1 |
| NCT06108232 | RECRUITING | Follicular Lymphoma; Tumor |
M.D. Anderson Cancer Center |
2024-03-15 | PHASE2 |
| NCT03930953 | ACTIVE_NOT_RECRUITING | Lymphoma, Non-Hodgkin |
Celgene |
2019-05-20 | PHASE1; PHASE2 |
| NCT06209619 | RECRUITING | B-Cell Non-Hodgkin Lymphoma-Recurrent; Diffuse Large B-Cell Lymphoma-Recurrent; Follicular Lymphoma-Recurrent; High Grade B-Cell Lymphoma-Recurrent; Primary Mediastinal Large B-Cell Lymphoma-Recurrent; Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent; B-Cell Non-Hodgkin Lymphoma-Refractory; Diffuse Large B-Cell Lymphoma-Refractory; Follicular Lymphoma-Refractory; High Grade B-Cell Lymphoma-Refractory; Primary Mediastinal Large B-Cell Lymphoma-Refractory; Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Refractory |
Nathan Denlinger |
2024-01-29 | PHASE1 |
| NCT04434196 | COMPLETED | Lymphoma, Non-Hodgkin |
Celgene |
2020-12-21 | PHASE1 |
| NCT03310619 | COMPLETED | Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular |
Celgene |
2017-12-20 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-07)
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>).