CC-220 + Anti-CD20 mAb for Lymphoma

No longer recruiting at 67 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celgene

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Lymphoblastic lymphoma, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new drug, CC-220 (also known as Iberdomide), both alone and in combination with other medications, for individuals with lymphoma that has returned or not responded to previous treatments. The goal is to determine if these new combinations can manage lymphoma more effectively than existing treatments. Suitable candidates for this trial are those who have undergone at least two prior treatments for their lymphoma and still have measurable disease impacting daily life. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude participants on chronic systemic immunosuppressive therapy or corticosteroids, so you might need to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that patients taking CC-220 (also known as iberdomide) for multiple myeloma generally tolerated the drug well. The most common side effects were mild, such as tiredness and low blood cell counts, and could be managed.

When combined with obinutuzumab and rituximab, similar studies have shown no new safety concerns. Obinutuzumab and rituximab are antibodies that help the immune system fight cancer cells. Rituximab is already approved by the FDA for various types of lymphoma, so its safety is well-known. Common side effects include mild fever and chills during infusion.

Overall, studies on the combination of CC-220 with either obinutuzumab or rituximab have shown that severe reactions are rare. These studies aim to find the right dose that balances effectiveness with safety. Since this is an early-phase trial, the main focus is on understanding how safe the treatment is for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CC-220 for lymphoma because it offers a unique approach compared to existing treatments like traditional chemotherapy and current monoclonal antibodies. Unlike most treatments that broadly target cancer cells, CC-220 works by modulating specific proteins that influence immune responses, potentially enhancing the body's ability to fight cancer. Furthermore, when combined with antibodies like obinutuzumab or rituximab, it may provide a more targeted attack on lymphoma cells, offering promise for improved efficacy and safety. This combination of action could lead to better outcomes for patients with different types of lymphoma, including relapsed or refractory cases.

What evidence suggests that this trial's treatments could be effective for relapsed or refractory lymphoma?

Research shows that CC-220, also known as iberdomide, may help treat lymphoma, either alone or with other medications. In this trial, participants in different cohorts will receive various treatments. Some will receive CC-220 alone; early results suggest it can lead to positive outcomes in patients whose lymphoma has returned or is not responding to treatment. Others will receive CC-220 combined with obinutuzumab, an antibody that targets cancer cells, which is generally well-tolerated and shows promising results. Additionally, some participants will receive CC-220 with rituximab, another antibody treatment, which has shown encouraging effects in treating blood cancers like lymphoma. Overall, these combinations are under study for their potential to effectively manage and treat certain types of lymphoma. ^{1 5 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Adults over 18 with relapsed or refractory lymphoma, who've had at least two prior treatments and have measurable disease. They must be in fairly good health (ECOG status 0-2), understand the risks of the drug potentially causing birth defects, and agree to follow strict pregnancy prevention measures if they can have children.

Inclusion Criteria

My lymphoma diagnosis is confirmed by lab tests, as per WHO standards.

Subjects must have specific laboratory values within defined ranges.

I am able to care for myself and perform daily activities.

Exclusion Criteria

I had a stem cell transplant less than 6 months ago or have ongoing side effects.

I have moderate to severe nerve damage.

I have not had major surgery within the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive CC-220 alone or in combination with an anti-CD20 mAb to determine the maximum tolerated dose

Up to 12 cycles (each cycle is 28 days)

Dose Expansion

Participants receive the recommended phase 2 dose of CC-220 alone or in combination with an anti-CD20 mAb to further evaluate safety and efficacy

Up to 24 cycles (each cycle is 28 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

• CC-220
• Obinutuzumab
• Rituximab

Trial Overview The study is testing CC-220's safety and optimal dose alone and combined with anti-CD20 mAbs (rituximab or obinutuzumab) for treating lymphoma that has returned after treatment. It includes an initial phase to find the best dose followed by a second phase to confirm its effectiveness.

How Is the Trial Designed?

Group I: Cohort G - CC-220 plus obinutuzumab in participants with follicular lymphoma grade 1-3a Experimental Treatment 2 Interventions

Group II: Cohort F - CC-220 and rituximab with follicular lymphoma grade 1-3a Experimental Treatment 2 Interventions

Group III: Cohort E - CC-220 and rituximab in participants with aggressive B-cell lymphoma Experimental Treatment 2 Interventions

Group IV: Cohort D -CC-220 monotherapy in participants with aggressive B-cell lymphoma and follicular lymphoma Experimental Treatment 1 Intervention

Group V: Cohort C - CC-220 and obinutuzumab in R/R FL or MZL subjects Experimental Treatment 2 Interventions

Subjects with R/R FL (Grade 1 to 3a) or MZL who have been allocated to Cohort C will receive CC-220 in combination with obinutuzumab. * Oral CC-220 at dose specified by cohort dose level from Day 1 to 21 of each 28-day cycle, up to PD or a maximum of 12 cycles. * Obinutuzumab will be administered at 1000 mg at C1D1, D8, and D15, and on D1 of every 28-day cycle from C2 to C6.

Group VI: Cohort B- CC-220 and rituximab in R/R B-Cell NHL subjects Experimental Treatment 2 Interventions

Subjects with R/R B-cell Non Hodgkin Lymphoma (NHL) who have been allocated to Cohort B will receive CC-220 in combination with rituximab. * Oral CC-220 at dose specified by cohort dose level from Day 1 to 21 of each 28-day cycle up to PD or maximum 24 cycles. * Rituximab will be administered at 375 mg/m2 IV at C1D1 and then on D8, D15, and D22 of C1 and then every 28-day cycle at D1 from C2 to C5, either by SC administration at a dose of 1400 mg or by IV infusion at a dose of 375 mg/m2.

Group VII: Cohort A- Monotherapy in R/R lymphoma subjects Experimental Treatment 1 Intervention

Subjects with Relapsed or Refractory (R/R) lymphoma who have been allocated to Cohort A will receive CC-220 monotherapy (MonoT). Oral CC-220 at dose specified by cohort dose level from Day 1 to 21 of each 28-day cycle, up to PD or a maximum of 24 cycles.

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Citations

1. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-First-Data-from-the-Marginal-Zone-Lymphoma-Cohort-of-the-Transcend-FL-Trial-Demonstrating-Deep-and-Durable-Responses-with-Breyanzi-lisocabtagene-maraleucel/default.aspx

Corporate news details “Liso-cel achieved high, lasting response rates in patients with relapsed or refractory marginal zone lymphoma, underscoring the potential of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10850340/

Advances in the treatment of relapsed/refractory marginal ... The treatment options for patients with relapsed/refractory (R/R) MZL are limited, underscoring the pressing need for novel therapeutic drugs.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40517417/

A phase 2 study of obinutuzumab combined with lenalidomide ... Abstract. Follicular lymphoma (FL) has a clinical course that is often characterized by high response rates to first-line therapy, followed by multiple relapses ...

4. firstwordpharma.com firstwordpharma.com/story/5973120

BMS fleshes out Breyanzi results in marginal zone lymphoma Among 66 efficacy-evaluable patients, BMS said 95.5% responded to the therapy, with 62.1% achieving a complete response and 88.6% maintaining ...

5. oncologypipeline.com oncologypipeline.com/apexonco/bristol-touts-marginal-zone-win

Bristol touts a marginal zone win | ApexOnco MZL is relatively indolent and accounts for around 7% of non-Hodgkin lymphoma cases. BeiGene's BTK inhibitor Brukinsa has accelerated approval, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189145/

Novel targeted drugs for follicular and marginal zone lymphoma These data granted zanubrutinib FDA approval for R/R MZL which, together with ibrutinib, are interesting non-chemotherapy strategies for this ...

7. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/iberdomide-hydrochloride-bristol-myers-squibb-relapsed-multiple-myeloma-likelihood-of-approval/

Iberdomide hydrochloride by Bristol-Myers Squibb for ... Iberdomide hydrochloride(CC-220) is under development for the treatment of systemic lupus erythematosus, relapsed/refractory multiple myeloma.

8. adisinsight.springer.com adisinsight.springer.com/trials/700324891

A Phase 1/2, Multicenter, Open-label Study to Assess Safety ... The purpose of this Phase 1/2 study is to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) ...