CC-220 + Anti-CD20 mAb for Lymphoma

Recruiting at 56 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

62 Participants Needed

Trial Summary

What is the purpose of this trial?

This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Subjects must have measurable disease as defined by specific criteria.

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

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

Treatment Details

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.

Participant Groups

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