Clinical Trials

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)

Check the CC-99282 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CC-99282 functions as an oral cereblon (CRBN) E3 ligase modulator that binds CRBN, co-opting its ubiquitin ligase complex to induce the selective proteasomal degradation of transcription factors Ikaros and Aiolos. This targeted depletion downregulates essential survival signaling pathways in malignant B-lymphocytes to trigger apoptosis, providing the biological mechanism for suppressing tumor growth in clinical conditions such as diffuse large B-cell lymphoma and follicular lymphoma.

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>).

Note: Technical data last updated: Sep 1, 2026.