Clinical Trials

Numerous clinical trials across Phase 1, Phase 2, and Phase 3 are evaluating mezigdomide (CC-92480) in relapsed or refractory multiple myeloma, acute myeloid leukemia, acute lymphoblastic leukemia, and healthy volunteers. Sponsored by major pharmaceutical companies such as Celgene and Bristol-Myers Squibb alongside academic institutions like Memorial Sloan Kettering Cancer Center, these studies encompass completed early-phase safety assessments, actively recruiting late-phase protocols, active non-recruiting trials, and expanded access programs.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06892522 RECRUITING
Multiple Myeloma
AbbVie
2025-06-30 PHASE1; PHASE2
NCT07348393 NOT_YET_RECRUITING
Relapsed or Refractory Multiple Myeloma (RRMM)
Assistance Publique - Hôpitaux de Paris
2026-02 PHASE2
NCT07356154 RECRUITING
Leukemia; Acute Leukemia; Relapse Leukemia; Refractory Leukemia; Refractory Acute Leukemia; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia
Memorial Sloan Kettering Cancer Center
2026-01-16 PHASE1; PHASE2
NCT07105059 RECRUITING
Multiple Myeloma
Memorial Sloan Kettering Cancer Center
2025-08-08 PHASE1
NCT06121843 RECRUITING
Multiple Myeloma
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
2024-02-22 PHASE1
NCT07612787 NOT_YET_RECRUITING
Myeloma Multiple
Centre Hospitalier Universitaire de Saint Etienne
2026-06-01 PHASE1; PHASE2
NCT05651932 RECRUITING
Multiple Myeloma; Myeloma; Myeloma Multiple
K36 Therapeutics, Inc.
2023-02-22 PHASE1
NCT07355335 NOT_YET_RECRUITING
KMT2A-rearranged; NPM1-mutant Refractory or Relapsed AML
Massachusetts General Hospital
2026-07-09 PHASE1
NCT07032714 RECRUITING
Relapsed Refractory Multiple Myeloma (RRMM)
Massachusetts General Hospital
2025-12-19 PHASE1
NCT06988488 RECRUITING
Multiple Myeloma
Celgene
2025-10-07 PHASE1; PHASE2
NCT06627751 RECRUITING
Extramedullary Disease in Multiple Myeloma; Recurrent Multiple Myeloma; Refractory Multiple Myeloma
Roswell Park Cancer Institute
2025-05-01 PHASE2
NCT02343042 RECRUITING
Multiple Myeloma
Karyopharm Therapeutics Inc
2015-10 PHASE1; PHASE2
NCT05519085 RECRUITING
Relapsed or Refractory Multiple Myeloma
Celgene
2022-09-20 PHASE3
NCT05981209 ACTIVE_NOT_RECRUITING
Recurrent Multiple Myeloma; Refractory Multiple Myeloma
Abdullah Khan
2023-12-21 PHASE1
NCT03989414 ACTIVE_NOT_RECRUITING
Multiple Myeloma
Celgene
2019-09-30 PHASE1; PHASE2
NCT05372354 RECRUITING
Multiple Myeloma
Bristol-Myers Squibb
2022-10-18 PHASE1; PHASE2
NCT06645678 RECRUITING
Relapsed Refractory Multiple Myeloma (RRMM)
YOUNGIL KOH
2024-11-26 PHASE1; PHASE2
NCT06050512 WITHDRAWN
Relapsed and Refractory Multiple Myeloma
Kathleen Dorritie
2023-10-02 PHASE1; PHASE2
NCT06048250 RECRUITING
Multiple Myeloma
City of Hope Medical Center
2024-04-09 PHASE1
NCT05552976 ACTIVE_NOT_RECRUITING
Relapsed or Refractory Multiple Myeloma
Bristol-Myers Squibb
2023-01-10 PHASE3
NCT03374085 TERMINATED
Multiple Myeloma
Celgene
2018-02-06 PHASE1; PHASE2
NCT06163898 TERMINATED
Multiple Myeloma
Celgene
2024-02-27 PHASE1
NCT06318676 COMPLETED
Renal Impairment
Celgene
2024-03-21 PHASE1
NCT05707390 COMPLETED
Hepatic Impairment
Bristol-Myers Squibb
2023-02-20 PHASE1
NCT05389722 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
2022-06-09 PHASE1
NCT04839809 COMPLETED
Healthy Volunteers
Celgene
2021-01-19 PHASE1
NCT04560738 COMPLETED
Healthy Volunteers
Celgene
2020-10-15 PHASE1
NCT04560738 Completed
Healthy Volunteers
Celgene
2020-10-15 Phase 1
NCT04211545 COMPLETED
Healthy Volunteer
Celgene
2019-10-21 PHASE1
NCT03803644 COMPLETED
Healthy Volunteer
Celgene
2018-12-21 PHASE1
NCT03803644 Completed
Healthy Volunteer
Celgene
2018-12-21 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-21)

Check the Mezigdomide (CC-92480) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mezigdomide functions as a potent cereblon E3 ubiquitin ligase modulator that binds cereblon with high affinity to induce the selective ubiquitination and degradation of target proteins. This targeted protein degradation disrupts downstream survival signaling and triggers apoptotic cell death, underlying its potent antimyeloma activity in relapsed or refractory multiple myeloma.

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.