438 Participants Needed

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

Recruiting at 128 trial locations
AD
Rs
Fl
BS
Overseen ByBMS Study Connect Contact Center http://www.bmsstudyconnect.com
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot have had any systemic anti-cancer treatment within 4 weeks or 5 half-lives before starting the trial. Also, you cannot be on chronic immunosuppressive therapy or corticosteroids.

What data supports the effectiveness of the drug combination CC-99282 and other anti-lymphoma agents for treating non-Hodgkin's lymphoma?

Epcoritamab, a component of the treatment, has shown strong antitumor activity in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, and has received approval for treating diffuse large B-cell lymphoma (DLBCL) after multiple lines of therapy. Additionally, tafasitamab, another component, has demonstrated effectiveness in combination with lenalidomide for relapsed or refractory DLBCL, leading to its approval for patients ineligible for stem cell transplantation.12345

Is the treatment CC-99282 + Anti-Lymphoma Agents generally safe for humans?

Tafasitamab, when used with lenalidomide, has been associated with some adverse events like infections, blood disorders, and gastrointestinal issues, but it was generally well tolerated in patients with diffuse large B-cell lymphoma. Epcoritamab, another component, showed common side effects such as fatigue, nausea, and diarrhea, but was also generally well tolerated in patients with relapsed or refractory large B-cell lymphoma.14567

What makes the drug CC-99282 + Tafasitamab unique for treating non-Hodgkin's lymphoma?

This drug combination is unique because it includes epcoritamab, a bispecific antibody that engages T-cells to target and kill cancerous B-cells, offering a novel approach for patients with relapsed or refractory non-Hodgkin's lymphoma, even those resistant to previous CD20 therapies.248910

What is the purpose of this trial?

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.

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

My Non-Hodgkin's Lymphoma has come back or didn't respond to treatment.
I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I have heart problems that affect my daily activities.
There are other requirements that you must meet or avoid to participate in the study.
I am on long-term immunosuppressants or have significant GVHD.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluation of the safety and tolerability of escalating doses of CC-99282 to determine the maximum tolerated dose (MTD) as monotherapy

Variable duration

Dose Expansion

Further evaluation of the safety and preliminary efficacy of CC-99282 alone or in combination with anti-lymphoma agents

Variable duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 6 years

Treatment Details

Interventions

  • CC-99282
  • Obinutuzumab
  • Rituximab
  • Tafasitamab
  • Tazemetostat
Trial Overview 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part B: Dose ExpansionExperimental Treatment5 Interventions
Group II: Part A: Dose EscalationExperimental Treatment1 Intervention

CC-99282 is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Epkinly for:
  • Diffuse large B-cell lymphoma
  • High-grade B-cell lymphoma
  • Follicular lymphoma
🇪🇺
Approved in European Union as Tepkinly for:
  • Diffuse large B-cell lymphoma
  • High-grade B-cell lymphoma
  • Follicular lymphoma
🇨🇦
Approved in Canada as Epkinly/Tepkinly for:
  • Diffuse large B-cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials
649
Recruited
130,000+
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Jay Backstrom profile image

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles profile image

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Findings from Research

Tafasitamab, an anti-CD19 monoclonal antibody, received accelerated approval in July 2020 for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide, marking it as the first second-line therapy approved for this patient group in the USA.
The drug is administered intravenously at a recommended dose of 12 mg per kg and is also being explored for use in other B-cell malignancies, indicating its potential versatility in treating various types of lymphoma.
Tafasitamab: First Approval.Hoy, SM.[2022]
Epcoritamab, a bispecific antibody targeting CD3 and CD20, was found to be safe and well-tolerated in 73 patients with relapsed or refractory B-cell non-Hodgkin lymphoma, with no dose-limiting toxic effects and a recommended phase 2 dose established at 48 mg.
The treatment showed promising efficacy, with an overall response rate of 68% in patients with diffuse large B-cell lymphoma and 90% in those with follicular lymphoma, indicating its potential as a viable therapy for these difficult-to-treat conditions.
Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study.Hutchings, M., Mous, R., Clausen, MR., et al.[2021]
In a study comparing tafasitamab combined with lenalidomide to lenalidomide alone in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), the combination therapy showed a significantly higher overall response rate of 67.1% compared to 34.2% for lenalidomide monotherapy.
The combination therapy also resulted in a higher complete response rate of 39.5% versus 13.2% for lenalidomide alone, indicating that tafasitamab enhances the efficacy of lenalidomide in treating this type of lymphoma.
RE-MIND: Comparing Tafasitamab + Lenalidomide (L-MIND) with a Real-world Lenalidomide Monotherapy Cohort in Relapsed or Refractory Diffuse Large B-cell Lymphoma.Zinzani, PL., Rodgers, T., Marino, D., et al.[2023]

References

Tafasitamab: First Approval. [2022]
Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. [2021]
RE-MIND: Comparing Tafasitamab + Lenalidomide (L-MIND) with a Real-world Lenalidomide Monotherapy Cohort in Relapsed or Refractory Diffuse Large B-cell Lymphoma. [2023]
Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. [2023]
Epcoritamab: First Approval. [2023]
A phase II multicenter study of the anti-CD19 antibody drug conjugate coltuximab ravtansine (SAR3419) in patients with relapsed or refractory diffuse large B-cell lymphoma previously treated with rituximab-based immunotherapy. [2019]
The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma. [2021]
Immunotherapeutic approaches for the treatment of childhood, adolescent and young adult non-Hodgkin lymphoma. [2018]
Immunity War: A Novel Therapy for Lymphoma Using T-cell Bispecific Antibodies. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment. [2021]
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