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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective against non-Hodgkin's lymphoma.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT)
Incidence of Adverse Events (AEs)
Maximum tolerated dose (MTD)
+6 more
Secondary outcome measures
DOR
Duration of response (DoR)
ORR
+13 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
36%
Vomiting
36%
Thrombocytopenia
36%
Nausea
27%
Fatigue
27%
Leukopenia
27%
Anaemia
27%
Hypokalaemia
18%
Hyperbilirubinaemia
18%
Neutropenia
18%
Insomnia
18%
Rash
18%
Nasal discomfort
18%
Hypomagnesaemia
18%
Musculoskeletal chest pain
9%
Encephalopathy
9%
Respiratory syncytial virus infection
9%
Upper respiratory tract infection
9%
Hypocalcaemia
9%
Ileus paralytic
9%
Enterocolitis
9%
Pyrexia
9%
Back pain
9%
Cellulitis
9%
Acute kidney injury
9%
Rash maculo-papular
9%
Abdominal pain
9%
Lymphopenia
9%
Pain
9%
Hypogammaglobulinaemia
9%
Cough
9%
Aspartate aminotransferase increased
9%
Hyponatraemia
9%
Headache
9%
Hypophosphataemia
9%
Dysphonia
9%
Oropharyngeal pain
9%
Hiatus hernia
9%
Arthralgia
9%
Nystagmus
9%
Sepsis
9%
Squamous cell carcinoma of skin
9%
Febrile neutropenia
9%
Bloody discharge
9%
Hypertension
9%
Neurotoxicity
9%
Acute respiratory failure
9%
Chapped lips
9%
Alanine aminotransferase increased
9%
Rhinorrhoea
9%
Asthenia
9%
Pneumonia
9%
Blood alkaline phosphatase increased
9%
Muscular weakness
9%
Abdominal pain upper
9%
Hypertriglyceridaemia
9%
Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
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 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

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
Tafasitamab
2016
Completed Phase 2
~180
CC-99282
2017
Completed Phase 2
~70
Obinutuzumab
2015
Completed Phase 3
~3250
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,416 Total Patients Enrolled
Poliana Patah, MD, PhDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
50 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,442 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What implications does CC-99282 carry for human health and wellbeing?

"As this is an early stage Phase 1 trial, our team at Power has assigned CC-99282 a score of 1 for safety due to the limited evidence supporting its effectiveness and potential risks."

Answered by AI

Could you provide a summary of the investigations into CC-99282 thus far?

"CC-99282 first saw clinical trials in 1993 at the National Institutes of Health Clinical Center, 9000 Rockville Pike. To date 855 studies have been completed and there are currently 515 active investigations occurring in multiple cities around Los Angeles and Maryland."

Answered by AI

In what medical instances is CC-99282 typically recommended?

"CC-99282 is a therapeutic agent which can be used to administer advance directives, perform medical procedures, and even treat patients suffering from diffuse large B-cell lymphoma (DLBCL)."

Answered by AI

Are there a variety of medical facilities administering this experiment in the state?

"At this time, the trial is running at 9 sites spread across numerous cities such as Los Angeles, Baltimore and Montreal. To reduce any associated travel costs of enrollment, choosing a location closest to you is recommended."

Answered by AI

How many patients is the research team recruiting for this experiment?

"This clinical trial necessitates 210 compliant patients to take part. Local Institution - 114 in Los Angeles and University Of Maryland At Baltimore in Baltimore are two of the many sites that can be attended by participants who meet the criteria for inclusion."

Answered by AI

Are recruiting efforts ongoing for this trial?

"Yes, this clinical trial is actively recruiting patients. The research was uploaded onto clinicaltrials.gov on May 20th 2019 and the details were last updated on November 3rd 2022. Nine sites need to fill a total of 210 positions for enrolment in this project."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
2019. "A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03930953.
~123 spots leftby Apr 2026
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