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Histone Methyltransferase Inhibitor

CC-99282 + Anti-Lymphoma Agents for Non-Hodgkin's Lymphoma

Phase 1 & 2
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Must not have
Impaired cardiac function or clinically significant cardiac disease
Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, CC-99282, for patients with certain types of lymphoma who haven't responded to other treatments. Researchers are finding the safest dose and checking if it works better alone or with other drugs.

Who is the study for?
This trial is for people with Non-Hodgkin's Lymphoma that has come back or hasn't responded to treatment. Participants should be fairly active and able to care for themselves (ECOG status 0-2). They can't join if they're on long-term immune-weakening drugs, have serious heart issues, are expected to live less than 2 months, or recently had cancer treatments.
What is being tested?
The study is testing the safety and initial effectiveness of a new drug called CC-99282 alone and combined with other lymphoma medications like Valemetostat, Tafasitamab, Obinutuzumab, and Rituximab in those whose lymphoma has relapsed or isn’t responding to current treatments.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as allergies or infusion-related symptoms. There might also be fatigue, digestive problems like nausea or diarrhea, blood cell count changes leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Non-Hodgkin's Lymphoma has come back or didn't respond to treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have heart problems that affect my daily activities.
Select...
I am on long-term immunosuppressants or have significant GVHD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
DOR
Duration of response (DoR)
ORR
+7 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
43%
Neutrophil count decreased
29%
Anaemia
29%
White blood cell count decreased
14%
Blood uric acid increased
14%
Back pain
14%
Erythema
14%
COVID-19
14%
Headache
14%
Neurotoxicity
14%
Neutropenia
14%
Palpitations
14%
Dry eye
14%
Diarrhoea
14%
Dyspepsia
14%
Chills
14%
Oedema peripheral
14%
Cytokine release syndrome
14%
Pneumonia
14%
Aspartate aminotransferase increased
14%
International normalised ratio increased
14%
Lymphocyte count decreased
14%
Platelet count decreased
14%
Dehydration
14%
Hypokalaemia
14%
Hypomagnesaemia
14%
Bone pain
14%
Myalgia
14%
Pain in jaw
14%
Dizziness
14%
Nystagmus
14%
Confusional state
14%
Cough
14%
Dyspnoea
14%
Tachypnoea
14%
Alopecia
14%
Rash maculo-papular
14%
Embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Dose ExpansionExperimental Treatment5 Interventions
Group II: Part A: Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-99282
2020
Completed Phase 2
~80
Tafasitamab
2016
Completed Phase 3
~630
Obinutuzumab
2014
Completed Phase 3
~3470
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
129,746 Total Patients Enrolled
Poliana Patah, MD, PhDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
16 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,248 Total Patients Enrolled

Media Library

CC-99282 (Histone Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03930953 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Part B: Dose Expansion, Part A: Dose Escalation
Non-Hodgkin's Lymphoma Clinical Trial 2023: CC-99282 Highlights & Side Effects. Trial Name: NCT03930953 — Phase 1 & 2
CC-99282 (Histone Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03930953 — Phase 1 & 2
~80 spots leftby Apr 2026
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