CC-93269 for Multiple Myeloma

Recruiting at 75 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celgene

Disqualifiers: CNS involvement, Recent transplants, Other cancers

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

Compensation: Varies

Number of Visits: Unknown

183 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CC-93269 for people with multiple myeloma, a type of blood cancer. The goal is to determine the best dose and evaluate its effectiveness for those whose disease has returned or hasn't responded to other treatments. It targets individuals with recurrent multiple myeloma who can still perform daily activities independently. Participants will receive the treatment in 28-day cycles to monitor their body's response. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that CC-93269 is likely to be safe for humans?

Research has shown that CC-93269 has been tested in people with relapsed and refractory multiple myeloma. The treatment offers potential benefits, but it also presents some safety concerns, as with any new treatment. Early results suggest that the side effects of CC-93269 can be managed. Some patients have shown strong positive responses, particularly at higher doses.

However, this is an early-stage study focused on understanding safety and determining the best dose. Consequently, limited safety information is available. Participants might experience some side effects, which is common in early trials. These findings are crucial for ensuring the treatment's safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which typically involve chemotherapy, immunotherapy, or proteasome inhibitors, CC-93269 offers a novel approach by targeting the BCMA (B-cell maturation antigen) on myeloma cells. This is exciting because BCMA is a specific marker found on the surface of multiple myeloma cells, and CC-93269 is designed to engage the immune system, particularly T-cells, to directly attack these cancerous cells. This dual-targeting mechanism has the potential to improve treatment effectiveness and offer a new avenue for patients who may not respond to existing therapies. Researchers are hopeful that this targeted approach could lead to better outcomes with fewer side effects compared to traditional treatments.

What evidence suggests that CC-93269 might be an effective treatment for multiple myeloma?

Research has shown that CC-93269, the investigational treatment in this trial, may help treat multiple myeloma, a type of blood cancer. Studies found that 54% of patients who took the drug experienced tumor shrinkage. In a group receiving higher doses, 83.3% showed noticeable improvement, with some even showing no signs of cancer. These findings suggest that CC-93269 could effectively manage the symptoms and progression of multiple myeloma. ^{1 3 4 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. Participants should be fairly active and able to care for themselves (ECOG Performance Status of 0 or 1) and have measurable signs of the disease. They can't join if they've had certain stem cell transplants recently, are dealing with another cancer needing treatment, or if their myeloma affects the central nervous system.

Inclusion Criteria

My multiple myeloma has come back and is not responding to treatment.

I am fully active or can carry out light work.

You must have a disease that can be measured by a special laboratory.

Exclusion Criteria

I had a stem cell transplant using my own cells less than 3 months ago.

My multiple myeloma has spread to my brain and is causing symptoms.

I had a stem cell transplant less than a year ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluation of safety and tolerability of escalating doses of CC-93269 to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD)

28-day cycles, up to 60 months

Monthly visits

Dose Expansion

Further evaluation of safety and efficacy of CC-93269 at or below the MTD in selected expansion cohorts

28-day cycles, up to 60 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• CC-93269

Trial Overview The study tests CC-93269, a new therapy designed to engage T cells in attacking cancer cells. It's an early-phase trial where doses will be increased gradually (Parts A and C) before being given to more patients at those levels (Parts B and D). The goal is to find out how safe it is and what effects it has on this type of blood cancer.

How Is the Trial Designed?

Group I: Administration of CC-93269 Experimental Treatment 1 Intervention

CC-93269 will be administered to each patient on a 28-day cycle

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10431068/

BMS-986349; CC-93269), A BCMA × CD3 T-CELL ... Results: In total, 70 pts had received IV ALNUC. Overall response rate (ORR) was 39% (27/70) with median DOR of 33.6 mo (95% CI, 10.6–NA).

2. ashpublications.org ashpublications.org/ashclinicalnews/news/4843/Early-Phase-Trial-Suggests-Bispecific-Antibody-CC

Early-Phase Trial Suggests Bispecific Antibody CC-93269 ... Overall, the rate of stringent complete response (sCR) was 17%, but, among the 9 patients receiving CC-93269 10 mg, the sCR rate was 44%. Among ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118580617

First Clinical Study of the B-Cell Maturation Antigen (BCMA ... Of the 12 pts treated with ≥ 6 mg CC-93269 in Cycle 1, 10 pts achieved a partial response (PR) or better (overall response rate; 83.3%), including 7 (58.3%) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12466123/

Targeting BCMA in multiple myeloma EM901 (CC-93269, BCMA-TCB2), preliminary results indicate potential efficacy; ORR: ∼50% reported; CR: not specified; median PFS: not ...

5. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/2011/498889/Alnuctamab-ALNUC-BMS-986349-CC-93269-a-2-1-B-Cell

Alnuctamab (ALNUC; BMS-986349; CC-93269), a 2+1 B-Cell ... Overall response rate (ORR) was 54% (39 of 72 efficacy-evaluable pts treated with SC ALNUC) across all doses, with responses deepening over time ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03486067

NCT03486067 | Study of CC-93269, a BCMA x CD3 T Cell ... Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma · Study Overview · Contacts and Locations.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7970693/

B-cell maturation antigen (BCMA) in multiple myeloma This review summarizes the most updated efficacy and safety data from clinical studies of BCMA-targeted therapies with a focus on ADCs and BITEs. Additionally, ...