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    DRUG:

    golcadomide (CC-99282)

    i
    Other names: CC-99282, BMS-986369, BMS986369, CC99282, BMS 986369, CC 99282
    Associations

    News

    Trials
    Company:
    BMS
    Drug class:
    Cereblon modulator, CRL4-CRBN E3 ubiquitin ligase modulator
    Related drugs:
    Associations

    News

    Trials
    10d
    EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=622, Recruiting, Genmab | Trial completion date: Jun 2031 --> Nov 2032 | Trial primary completion date: Jun 2031 --> Nov 2032
    Trial completion date • Trial primary completion date • Adverse events • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14) • CCND1 overexpression
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • prednisone • Jaypirca (pirtobrutinib) • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • golcadomide (CC-99282)
    11d
    Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment (clinicaltrials.gov)
    P1, N=30, Recruiting, Celgene | Not yet recruiting --> Recruiting
    Enrollment open
    |
    golcadomide (CC-99282)
    18d
    CC-220-DLBCL-001: Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma (clinicaltrials.gov)
    P1, N=174, Recruiting, Celgene | Trial primary completion date: Sep 2024 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Polivy (polatuzumab vedotin-piiq) • iberdomide (CC-220) • golcadomide (CC-99282)
    1m
    Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse (clinicaltrials.gov)
    P2, N=65, Recruiting, The Lymphoma Academic Research Organisation | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    golcadomide (CC-99282)
    1m
    CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=121, Recruiting, Hoffmann-La Roche | Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 expression
    |
    Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
    2ms
    A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants (clinicaltrials.gov)
    P1, N=35, Completed, Celgene | Recruiting --> Completed
    Trial completion
    |
    itraconazole • golcadomide (CC-99282) • rifampicin
    2ms
    CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With Iberdomide and/or Golcadomide in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=125, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2028 --> Mar 2029 | Trial primary completion date: Jul 2026 --> Mar 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 expression
    |
    Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
    2ms
    EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=622, Recruiting, Genmab | N=394 --> 622 | Trial completion date: Nov 2032 --> Jun 2031 | Trial primary completion date: Nov 2032 --> Jun 2031
    Enrollment change • Trial completion date • Trial primary completion date • Adverse events • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14) • CCND1 overexpression
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • prednisone • Jaypirca (pirtobrutinib) • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • golcadomide (CC-99282)
    3ms
    A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (clinicaltrials.gov)
    P1/2, N=85, Recruiting, Bristol-Myers Squibb | Trial completion date: Aug 2030 --> Aug 2029 | Trial primary completion date: Jan 2027 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    golcadomide (CC-99282)
    3ms
    GOLSEEK-2: A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (clinicaltrials.gov)
    P2, N=90, Recruiting, Celgene | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Rituxan (rituximab) • cyclophosphamide • pegylated liposomal doxorubicin • vincristine • prednisone • bendamustine • golcadomide (CC-99282)
    3ms
    Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Celgene
    New P1 trial
    |
    golcadomide (CC-99282)
    4ms
    A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P1, N=16, Completed, Celgene | Active, not recruiting --> Completed | Phase classification: P1b --> P1 | N=50 --> 16 | Trial completion date: May 2025 --> May 2024 | Trial primary completion date: Nov 2024 --> May 2024
    Trial completion • Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    Gazyva (obinutuzumab) • golcadomide (CC-99282)
    5ms
    GOLSEEK-1: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (clinicaltrials.gov)
    P3, N=850, Recruiting, Celgene | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • golcadomide (CC-99282)
    5ms
    Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma (clinicaltrials.gov)
    P2, N=36, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Gazyva (obinutuzumab) • golcadomide (CC-99282)
    6ms
    GOLSEEK-2: A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Celgene
    New P2 trial
    |
    Rituxan (rituximab) • cyclophosphamide • pegylated liposomal doxorubicin • vincristine • prednisone • bendamustine • golcadomide (CC-99282)
    6ms
    A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants (clinicaltrials.gov)
    P1, N=36, Recruiting, Celgene | Not yet recruiting --> Recruiting
    Enrollment open
    |
    itraconazole • golcadomide (CC-99282) • rifampicin
    7ms
    A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Celgene
    New P1 trial
    |
    itraconazole • golcadomide (CC-99282) • rifampicin
    7ms
    GOLSEEK-1: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (clinicaltrials.gov)
    P3, N=850, Not yet recruiting, Celgene
    New P3 trial
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • golcadomide (CC-99282)
    9ms
    Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse (clinicaltrials.gov)
    P2, N=65, Not yet recruiting, The Lymphoma Academic Research Organisation
    New P2 trial
    |
    golcadomide (CC-99282)
    10ms
    CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1, N=18, Recruiting, Nathan Denlinger | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    Rituxan (rituximab) • Mabtas (rituximab biosimilar) • golcadomide (CC-99282)
    10ms
    CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Nathan Denlinger
    New P1 trial • CAR T-Cell Therapy
    |
    Rituxan (rituximab) • Mabtas (rituximab biosimilar) • golcadomide (CC-99282)
    10ms
    EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=394, Recruiting, AbbVie | Trial completion date: May 2029 --> Nov 2032 | Trial primary completion date: May 2029 --> Nov 2032
    Trial completion date • Trial primary completion date • Adverse events • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14) • CCND1 overexpression
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • prednisone • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • golcadomide (CC-99282)
    11ms
    Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma (clinicaltrials.gov)
    P1, N=174, Recruiting, Celgene | Phase classification: P1b --> P1
    Phase classification • Combination therapy
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Polivy (polatuzumab vedotin-piiq) • iberdomide (CC-220) • golcadomide (CC-99282)
    12ms
    Investigation of the Synergistic Combination of a Novel Celmod (CC-99282) and BET Inhibitors in Preclinical DLBCL (ASH 2023)
    Similar synergistic effects were found when combining GOLCA with JQ1, another tool compound BET inhibitor, confirming BET inhibition potentiates the anti-DLBCL effects of the CELMoD agent. BET inhibition potentiates anti-proliferative effects of GOLCA in DLBCL cells through synergistic induction of p21 and inhibition of E2F signaling. The synergetic effects of BMS-986158 and GOLCA suggest potential clinical benefits of combining lower doses of single agents to achieve better efficacy with reduced risk of adverse effects.
    Preclinical
    |
    IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon) • AURKA (Aurora kinase A) • CHEK1 (Checkpoint kinase 1) • BRD4 (Bromodomain Containing 4) • CDKN1A (Cyclin-dependent kinase inhibitor 1A) • CDC45 (Cell Division Cycle 45) • E2F1 (E2F transcription factor 1) • IL17RB (Interleukin 17 Receptor B) • SKP2 (S-phase kinase-associated protein 2)
    |
    JQ-1 • ezobresib (BMS-986158) • golcadomide (CC-99282)
    12ms
    A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (clinicaltrials.gov)
    P1/2, N=85, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    golcadomide (CC-99282)
    1year
    EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=394, Recruiting, AbbVie | Phase classification: P1b/2 --> P2
    Phase classification • Adverse events • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14) • CCND1 overexpression
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • prednisone • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • golcadomide (CC-99282)
    1year
    Golcadomide (GOLCA; CC-99282), a Novel CELMoD Agent, Plus R-CHOP in Patients (pts) with Previously Untreated Aggressive B-Cell Lymphoma (a-BCL): Safety and Efficacy Results from Phase 1b Dose Expansion (ASH 2023)
    Introduction Up to 40% of pts with diffuse large B-cell lymphoma (DLBCL) relapse after first-line chemo-immunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)...CC-220-DLBCL-001 (NCT04884035) is an ongoing open-label, multicenter, dose escalation and expansion trial to assess safety and preliminary efficacy of CELMoD agents + R-CHOP for untreated a-BCL...Efficacy results and substantial ctDNA decrease indicate robust clinical activity in frontline DLBCL, with a high CMR rate at EoT, particularly among patients treated at DL1. Study support Bristol Myers Squibb.
    Clinical • P1 data
    |
    IKZF1 (IKAROS Family Zinc Finger 1)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • iberdomide (CC-220) • golcadomide (CC-99282)
    1year
    Efficacy and Safety of Golcadomide, a Novel Cereblon E3 Ligase Modulator (CELMoD) Agent, Combined with Rituximab in a Phase 1/2 Open-Label Study of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (ASH 2023)
    Golcadomide oral therapy combined with rituximab showed promising efficacy in heavily pretreated patients with R/R DLBCL, including 1 durable response over 300 days. Golcadomide can be safely combined with rituximab, and the combination showed a safety profile similar to that previously reported for golcadomide monotherapy.
    Clinical • P1/2 data
    |
    IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon)
    |
    Rituxan (rituximab) • golcadomide (CC-99282)
    1year
    Trial in Progress: Treatment of Newly-Diagnosed Follicular Lymphoma with Celmod BMS-986369, Rituximab +/- Nivolumab: An Umbrella Phase II Investigator-Initiated Study (ASH 2023)
    Survival probabilities will be reported using Kaplan-Meier analysis. Status: This trial received IRB approval on 14 July 2023 (HREC/88597/Austin-2023) at Austin Health, Heidelberg, Australia.
    P2 data • PD(L)-1 Biomarker
    |
    IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon)
    |
    Opdivo (nivolumab) • Rituxan (rituximab) • golcadomide (CC-99282)
    1year
    Pharmacodynamic Biomarkers and CtDNA Support the Mechanism of Action and Clinical Efficacy of Golcadomide (CC-99282) Combined with R-CHOP in Previously Untreated Aggressive B-Cell Lymphoma (ASH 2023)
    In the ongoing CC-220-DLBCL-001 study (NCT04884035), GOLCA dose finding is underway in patients with previously untreated aggressive B-cell lymphoma (BCL), in combination with R-CHOP in 21-day (D) cycles (C), at a variety of GOLCA dose levels (DLs) and schedules: DL-1 = 0.2 mg D1-7, DL1 = 0.4 mg D1-7, and DL2 = 0.4 mg D1-10. Translational data demonstrate the potency of GOLCA and will support future frontline clinical trial designs in patients with untreated aggressive BCL. Study support: Celgene, a Bristol-Myers Squibb Company
    Clinical • PK/PD data • Circulating tumor DNA
    |
    IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon)
    |
    Rituxan (rituximab) • iberdomide (CC-220) • golcadomide (CC-99282)
    1year
    Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Gazyva (obinutuzumab) • golcadomide (CC-99282)
    1year
    TOP-FLOR: Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD BMS-986369, Rituximab +/- Nivolumab. (clinicaltrials.gov)
    P2, N=40, Recruiting, Olivia Newton-John Cancer Research Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive • LDH elevation
    |
    Opdivo (nivolumab) • Rituxan (rituximab) • golcadomide (CC-99282)
    over1year
    A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=121, Recruiting, Hoffmann-La Roche | Trial completion date: Apr 2027 --> Jul 2028 | Trial primary completion date: Apr 2025 --> Jul 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 expression
    |
    Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
    over1year
    Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=124, Recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2025 --> Jun 2027
    Trial completion date • Combination therapy
    |
    lenalidomide • golcadomide (CC-99282) • ianalumab (VAY736)
    over1year
    OPEN-LABEL PHASE 1/2 STUDY OF CC-99282, A CEREBLON E3 LIGASE MODULATOR (CELMOD) AGENT ± RITUXIMAB, IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) NON-HODGKIN LYMPHOMA (NHL) (ICML 2023)
    CC-99282 oral monotherapy continues to show promising efficacy in heavily pretreated pts with R/R NHL, achieving durable responses up to 900 d. CC-99282 can be safely combined with RTX, with no DLTs reported. This study is ongoing, with continued enrolment in the monotherapy and CC-99282 + RTX combination expansion cohorts.
    Clinical • P1/2 data
    |
    IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon)
    |
    Rituxan (rituximab) • golcadomide (CC-99282)
    over1year
    TOP-FLOR: Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD BMS-986369, Rituximab +/- Nivolumab. (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Olivia Newton-John Cancer Research Institute
    New P2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive • LDH elevation
    |
    Opdivo (nivolumab) • Rituxan (rituximab) • golcadomide (CC-99282)
    over1year
    EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1b/2, N=394, Recruiting, AbbVie | N=132 --> 394
    Enrollment change • Adverse events • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14) • CCND1 overexpression
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • prednisone • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • golcadomide (CC-99282)
    over1year
    PLATFORM: A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies (clinicaltrials.gov)
    P1/2, N=62, Completed, Celgene | Active, not recruiting --> Completed
    Trial completion
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    Opdivo (nivolumab) • Imfinzi (durvalumab) • Imbruvica (ibrutinib) • Breyanzi (lisocabtagene maraleucel) • avadomide (CC-122) • iberdomide (CC-220) • relatlimab (BMS-986016) • golcadomide (CC-99282)
    almost2years
    PLATFORM: A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies (clinicaltrials.gov)
    P1/2, N=62, Active, not recruiting, Celgene | Trial completion date: Jul 2025 --> Jan 2023 | Trial primary completion date: Jul 2025 --> Jan 2023
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    Opdivo (nivolumab) • Imfinzi (durvalumab) • Imbruvica (ibrutinib) • Breyanzi (lisocabtagene maraleucel) • avadomide (CC-122) • iberdomide (CC-220) • relatlimab (BMS-986016) • golcadomide (CC-99282)
    2years
    Phase 1b Trial of Cereblon-Modulating Agents Iberdomide and CC-99282 Plus R-CHOP in Previously Untreated Aggressive B-Cell Lymphoma (ASH 2022)
    The standard of care for patients (pts) with DLBCL is chemo-immunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); however, up to 45%–50% of pts relapse after first-line (1L) R-CHOP...Lenalidomide (LEN) modulates cereblon E3 ligase, leading to antitumor effects and degradation of target proteins...The study opened on September 15, 2021 and is currently recruiting. Study support: This study is supported by Bristol Myers Squibb.
    P1 data
    |
    IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon)
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • iberdomide (CC-220) • golcadomide (CC-99282)
    2years
    Elucidating the Molecular Mechanisms of Action of CC-99282, a Novel Cereblon (CRBN) E3 Ligase Modulator (CELMoD) Agent, Via Genome-Wide CRISPR Screen in a Preclinical Model of Non-Hodgkin Lymphoma (NHL) (ASH 2022)
    Compared with immunomodulatory agents such as lenalidomide that also degrade Ikaros/Aiolos, CC-99282 demonstrates a faster, deeper, and more sustained degradation of these transcription factors...Venetoclax (VEN), a BCL2 inhibitor approved for the treatment of pts with chronic lymphocytic leukemia and acute myeloid leukemia, was tested in aggressive NHL cell lines alone or in combination with CC-99282...Lastly, combination of CC-99282 with CDK4/6 inhibitors palbociclib/abemaciclib, which prevent cell-cycle progression, showed strong synergistic effects in NHL cell lines without RB1 loss or CCND3 mutations...This study revealed genetic alterations that may be associated with clinical response to CC-99282 in pts with NHL. These in vitro data highlight potential biomarkers that could facilitate patient stratification in future clinical trials and provide rationale for combination therapies that may improve clinical outcomes for pts with R/R NHL.
    Preclinical • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • RB1 (RB Transcriptional Corepressor 1) • BCL6 (B-cell CLL/lymphoma 6) • IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon) • CCND3 (Cyclin D3) • DDB1 (Damage Specific DNA Binding Protein 1) • AMBRA1 (Autophagy And Beclin 1 Regulator 1) • BECN1 (Beclin 1) • IRF7 (Interferon Regulatory Factor 7)
    |
    BCL2 expression • BCL2 translocation
    |
    Venclexta (venetoclax) • Ibrance (palbociclib) • lenalidomide • Verzenio (abemaciclib) • golcadomide (CC-99282)
    2years
    Association of Immune Dynamics and Treatment Outcome in Patients (pts) with Relapsed/Refractory Non-Hodgkin Lymphoma (R/R NHL) Treated with the Novel Cereblon (CRBN) E3 Ligase Modulator (CELMoD) Agent CC‑99282 (ASH 2022)
    CC-99282 (BMS-986369) is a novel CELMoD® agent that has enhanced antiproliferative, apoptotic, and immune-stimulatory effects compared with other immunomodulatory agents in various preclinical NHL models...Responder subsets were identified based on effects on Tregs and immune activation; however, all cases led to durable responses. Further study and validation of these data could provide rationale for pt selection and combination strategies.
    Clinical
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    IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon) • TNFA (Tumor Necrosis Factor-Alpha) • CSF2 (Colony stimulating factor 2)
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    CSF2 elevation
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    golcadomide (CC-99282)