CC-95266 for Multiple Myeloma

Not currently recruiting at 23 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Juno Therapeutics, a Subsidiary of Celgene

Must be taking: Immunomodulatory, Proteasome inhibitors

Disqualifiers: CNS involvement, Plasma cell leukemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CC-95266 for people with multiple myeloma, a type of blood cancer, who have not responded to or have seen their disease return after previous treatments. The main goal is to determine if CC-95266 is safe and effective in controlling the disease. Participants will receive this treatment after specific chemotherapy. Suitable candidates have multiple myeloma that has returned or is unresponsive to treatment and have undergone at least three different treatments. 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 it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that CC-95266 is likely to be safe for humans?

Research has shown that CC-95266 generally has a manageable safety profile for people with multiple myeloma. In a previous study, participants experienced some side effects, but these were usually manageable. The treatment led to strong and lasting improvements, even at different dose levels, indicating that CC-95266 is fairly well-tolerated. However, as this is an early-phase trial, more information about its safety is needed. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which often include combinations of chemotherapy, immunotherapy, and targeted drugs, CC-95266 works differently by targeting a specific protein found on the surface of cancer cells. This protein, called BCMA (B-cell maturation antigen), is crucial for the survival and growth of multiple myeloma cells. Researchers are excited about CC-95266 because it employs a novel mechanism of action, potentially offering a more precise attack on the cancer cells while sparing healthy ones. This targeted approach could lead to fewer side effects and improved outcomes for patients.

What evidence suggests that CC-95266 might be an effective treatment for multiple myeloma?

Studies have shown that CC-95266, a specialized CAR T-cell therapy, holds promise for treating multiple myeloma that has returned or not responded to other treatments. Research indicates that this therapy can lead to strong and lasting improvements, even when other treatments have failed. Early results suggest that CC-95266 works effectively and has manageable side effects. This treatment targets a specific part of cancer cells, aiding the immune system in fighting the cancer. Overall, early evidence supports its potential as a new option for patients with challenging cases of multiple myeloma. ^{1 2 3 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 adults over 18 with multiple myeloma that has come back or hasn't responded to treatment. They must have had at least three prior treatments (or one to three for a specific group) and show signs of disease progression. Good physical health and organ function are required, but those with central nervous system involvement, certain medical histories, or active autoimmune diseases can't join.

Inclusion Criteria

I am fully active or can carry out light work.

My multiple myeloma has worsened or not responded to treatment within the last 12 months.

My organs are working well.

Exclusion Criteria

I have a significant brain or nerve condition.

I am on medication to suppress my immune system due to an autoimmune disease.

I have or had multiple myeloma affecting my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide

1 week

Treatment

Participants receive CC-95266 for the treatment of relapsed and/or refractory multiple myeloma

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CC-95266

Trial Overview The study tests the safety and initial effectiveness of CC-95266 in patients whose multiple myeloma has relapsed or is resistant to treatment. It also involves other drugs like Cyclophosphamide, Fludarabine, and Bendamustine as part of the therapy regimen.

How Is the Trial Designed?

Group I: Administration of CC-95266 Experimental Treatment 4 Interventions

Subjects will receive CC-95266 after completion of lymphodepleting (LD) chemotherapy (fludarabine and cyclophosphamide)

Who Is Running the Clinical Trial?

Juno Therapeutics, a Subsidiary of Celgene

Lead Sponsor

Trials

12

Recruited

1,400+

Published Research Related to This Trial

In a first-in-humans clinical trial involving 16 patients with heavily treated multiple myeloma, CAR-BCMA T cells demonstrated an impressive overall response rate of 81%, with 63% achieving very good partial or complete responses.

The treatment was associated with significant anti-myeloma activity, including eradication of bone marrow myeloma and resolution of soft-tissue plasmacytomas, although some patients experienced severe but reversible cytokine-release syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T Cells Genetically Modified to Express an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor Cause Remissions of Poor-Prognosis Relapsed Multiple Myeloma. Brudno, JN., Maric, I., Hartman, SD., et al.[2019]

The introduction of 18 new treatments for multiple myeloma over the past 12 years has significantly improved patient survival rates, extending median survival by 3 to 4 times.

Current treatment strategies emphasize the use of triplet therapies for both transplant and non-transplant patients, with maintenance therapies like lenalidomide showing benefits in prolonging progression-free and overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress and Paradigms in Multiple Myeloma. Anderson, KC.[2018]

Monoclonal antibodies like daratumumab and elotuzumab, especially when combined with other treatments, have shown high response rates and improved survival in patients with relapsed and refractory multiple myeloma, highlighting their efficacy in targeting specific plasma cell proteins.

CAR T cell therapy, particularly targeting B-cell maturation antigen (BCMA), has demonstrated dramatic remissions in patients with difficult-to-treat multiple myeloma, although it can lead to significant side effects like cytokine release syndrome and neurotoxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hematologic Malignancies: Plasma Cell Disorders. Dhodapkar, MV., Borrello, I., Cohen, AD., et al.[2019]

Melphalan and prednisolone (MP) have been the standard treatment for multiple myeloma for over 25 years, achieving a 50-60% objective response rate, but complete remission is rare and median survival is only 24 to 30 months.

High-dose therapy combined with autologous bone marrow transplantation has shown promising results, significantly improving response rates, event-free survival, and overall survival compared to standard therapies, as demonstrated in randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in the treatment of multiple myeloma]. Wada, M., Mizoguchi, H.[2015]

C-CAR088, a novel anti-BCMA CAR T-cell therapy, demonstrated a high overall response rate of 96.4% in patients with relapsed or refractory multiple myeloma, with significant rates of complete response (10.7%) and stringent complete response (46.4%).

The therapy showed a favorable safety profile, with 93.5% of patients experiencing cytokine release syndrome (CRS) that was manageable and reversible, and no dose-limiting toxicities reported across the tested dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. Qu, X., An, G., Sui, W., et al.[2022]

In a phase 1 study of 33 patients with relapsed or refractory multiple myeloma, the CAR T-cell therapy bb2121 demonstrated a high objective response rate of 85%, with 45% of patients achieving complete responses.

While bb2121 showed promising antitumor activity, it also had significant safety concerns, with 76% of patients experiencing cytokine release syndrome and 42% experiencing neurological toxic effects, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. Raje, N., Berdeja, J., Lin, Y., et al.[2021]

Citations

1. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/219/499690/BMS-986393-CC-95266-a-G-Protein-Coupled-Receptor

BMS-986393 (CC-95266), a G Protein-Coupled Receptor ... ... Multiple Myeloma (RRMM): Updated Results from a Phase 1 Study Available ... Here, we present updated safety and efficacy data from the study.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04674813

NCT04674813 | A Study of CC-95266 in Participants With ... The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123048231

BMS-986393 (CC-95266), a G Protein-Coupled Receptor ... In this first-in-human study, BMS-986393 showed a manageable safety profile and deep and durable responses, including MRD negativity, at all tested dose levels.

4. myeloma.org myeloma.org/videos/gprc5d-targeted-car-t-cell-therapy-rrmm-phase-1-study-outcomes-bms-986393-cc-95266

Targeted CAR T-Cell Therapy for Relapsed Myeloma The preliminary data supports BMS-986393 as a potential treatment option for relapsed myeloma patients, regardless of their prior BCMA-directed therapy status.

5. cancernetwork.com cancernetwork.com/view/bms-986393-appears-effective-safe-in-relapsed-refractory-multiple-myeloma

BMS-986393 Appears Effective, Safe in Relapsed/ ... Treatment with BMS-986393 (CC-95266), a GPRC5D-targeted CAR T-cell therapy, appeared to yield significant efficacy and limited, self-resolving toxicity.

6. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT04674813

A Study of CC-95266 in Participants With Relapsed and/or ... The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT04674813

A Study of CC-95266 in Participants With Relapsed and/or ... A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma ... data from the phase 1 CC-95266-MM-001 trial (NCT04674813) that ...