Obinutuzumab + CC-99282 for Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by Dai Chihara, M D

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP3A inhibitors, Corticosteroids

Disqualifiers: CNS lymphoma, HIV, Hepatitis, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, obinutuzumab and CC-99282, to treat patients with untreated, high tumor burden follicular lymphoma. Obinutuzumab helps the immune system identify cancer cells, while CC-99282 enhances the immune response to destroy these cells. The goal is to see if this combination can effectively control the cancer and improve patient outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on strong CYP3A inhibitors, you must stop them and wait for a 7-day washout period (time without taking certain medications) or 5 half-lives, whichever is longer, before starting the trial.

What data supports the effectiveness of the drug Obinutuzumab + CC-99282 for Follicular Lymphoma?

Obinutuzumab has shown effectiveness in treating follicular lymphoma, especially in patients who did not respond to or relapsed after rituximab treatment, by significantly prolonging progression-free survival when combined with bendamustine. This suggests potential effectiveness when combined with other treatments like CC-99282. ^{1 2 3 4 5}

What makes the drug Obinutuzumab + CC-99282 unique for treating follicular lymphoma?

Obinutuzumab is a new type of anti-CD20 antibody that is engineered to enhance its ability to kill cancer cells, making it potentially more effective than the current standard, rituximab, especially for patients who have not responded to or have relapsed after rituximab treatment. This combination with CC-99282, a novel treatment, could offer a new option for patients with follicular lymphoma, particularly those who have limited responses to existing therapies. ^{1 2 3 6 7}

Research Team

Dai Chihara, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with previously untreated, high tumor burden follicular lymphoma. Participants must have certain blood count levels, no prior cancer treatments, and be in a specific disease stage. They should not be pregnant or breastfeeding and must agree to contraception measures.

Inclusion Criteria

My condition is at stage II, III, or IV.

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I have had cancer other than B-NHL but have been free of it for over 3 years.

I do not have any severe illnesses that could affect my safety or the study's results.

I do not have serious heart problems or recent heart attacks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive obinutuzumab and CC-99282 for up to 6 cycles, each cycle lasting 28 days

24 weeks

Extended Treatment

Participants may continue to receive obinutuzumab and CC-99282 for Cycles 7-12 based on disease status

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 months

Treatment Details

Interventions

• CC-99282 (Other)
• Obinutuzumab (Monoclonal Antibodies)

Trial Overview The study tests the effectiveness of obinutuzumab combined with CC-99282 in controlling high tumor burden follicular lymphoma that hasn't been treated before. It's a Phase 2 trial focusing on these two drugs' impact on this type of lymphoma.

Participant Groups

Group I: Obinutuzumab+CC-99282 Experimental Treatment 2 Interventions

Participants will receive obinutuzumab and CC-99282 together for up to 12 study cycles. Each study cycle is 28 days. Participants will first receive the study drugs for Cycles 1-6. Then after participants complete Cycle 6, the study doctor will decide based on the status of the disease if participant will continue to receive the study drugs for Cycles 7-12 or if participant will stop receiving them.

CC-99282 is already approved in Canada for the following indications:

Approved in Canada as Epkinly/Tepkinly for:

• Diffuse large B-cell lymphoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Obinutuzumab, a new anti-CD20 monoclonal antibody, has shown promising efficacy in treating follicular lymphoma (FL) and has been approved by the FDA for use in combination with bendamustine for patients who have relapsed after rituximab treatment.

Ongoing phase III trials, such as the GALLIUM trial, suggest that obinutuzumab may soon be established as a first-line treatment for FL, potentially replacing rituximab as the gold standard, although some safety concerns remain to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obinutuzumab in follicular lymphoma. Martinez-Calle, N., Figueroa-Mora, R., Villar-Fernandez, S., et al.[2017]

The study developed 64Cu-labeled F(ab')2 fragments of obinutuzumab, which showed rapid and sustained tumor uptake in CD20-positive lymphoma models, indicating potential for effective imaging of lymphoma.

With a radiochemical purity of over 98% and significantly higher tumor uptake compared to controls, this method could enhance noninvasive evaluation of CD20 levels in clinical settings, improving diagnosis and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. Kang, L., Li, C., Rosenkrans, ZT., et al.[2021]

The combination of obinutuzumab and atezolizumab was found to be safe and tolerable in a phase 1b study involving 49 patients with relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), with no new toxicities reported.

The treatment showed preliminary efficacy, achieving a 54% objective response rate in the FL cohort and a 17% response rate in the DLBCL cohort, with median progression-free survival of 9 months for FL and 3 months for DLBCL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of Atezolizumab and Obinutuzumab in Patients with Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-Cell Lymphoma: Results from a Phase 1b Study. Palomba, ML., Till, BG., Park, SI., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

Obinutuzumab: A Review in Rituximab-Refractory or -Relapsed Follicular Lymphoma. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Enhanced anti-tumor activity of the glycoengineered type II CD20 antibody obinutuzumab (GA101) in combination with chemotherapy in xenograft models of human lymphoma. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

Obinutuzumab in follicular lymphoma. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Combination of Atezolizumab and Obinutuzumab in Patients with Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-Cell Lymphoma: Results from a Phase 1b Study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

GA101 (a Novel Anti-CD20 Monoclonal Antibody)-Induced Lichenoid Eruption. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Obinutuzumab for the treatment of indolent lymphoma. [2018]