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DRUG:

golcadomide (CC-99282)

i
Other names: CC-99282, BMS-986369, BMS986369, CC99282, BMS 986369, CC 99282
Associations
Company:
BMS
Drug class:
Cereblon modulator, CRL4-CRBN E3 ubiquitin ligase modulator
Associations
6d
CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=121, 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)
16d
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)
1m
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)
2ms
Enrollment open
|
golcadomide (CC-99282)
2ms
Trial primary completion date • Combination therapy
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Polivy (polatuzumab vedotin-piiq) • iberdomide (CC-220) • golcadomide (CC-99282)
2ms
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)
3ms
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)
3ms
Trial completion
|
itraconazole • golcadomide (CC-99282) • rifampicin
3ms
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)
3ms
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)
4ms
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)
5ms
Enrollment open • Combination therapy • Metastases
|
Rituxan (rituximab) • cyclophosphamide • pegylated liposomal doxorubicin • vincristine • prednisone • bendamustine • golcadomide (CC-99282)
5ms
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)
6ms
Enrollment open
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • golcadomide (CC-99282)
7ms
Enrollment open
|
Gazyva (obinutuzumab) • golcadomide (CC-99282)
7ms
New P2 trial
|
Rituxan (rituximab) • cyclophosphamide • pegylated liposomal doxorubicin • vincristine • prednisone • bendamustine • golcadomide (CC-99282)
7ms
Enrollment open
|
itraconazole • golcadomide (CC-99282) • rifampicin
8ms
New P3 trial
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • golcadomide (CC-99282)
10ms
New P2 trial
|
golcadomide (CC-99282)
11ms
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)
11ms
New P1 trial • CAR T-Cell Therapy
|
Rituxan (rituximab) • Mabtas (rituximab biosimilar) • golcadomide (CC-99282)
11ms
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)
12ms
Phase classification • Combination therapy
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Polivy (polatuzumab vedotin-piiq) • iberdomide (CC-220) • golcadomide (CC-99282)
1year
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
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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)
1year
Enrollment open
|
golcadomide (CC-99282)
1year
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
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)
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Rituxan (rituximab) • 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
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IKZF1 (IKAROS Family Zinc Finger 1)
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • iberdomide (CC-220) • 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
New P2 trial
|
Gazyva (obinutuzumab) • golcadomide (CC-99282)
over1year
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
New P2 trial
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive • LDH elevation
|
Opdivo (nivolumab) • Rituxan (rituximab) • golcadomide (CC-99282)
over1year
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
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)