CC-95266 for Multiple Myeloma

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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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 MM).

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.

What data supports the effectiveness of the treatment CC-95266 for multiple myeloma?

The research highlights the effectiveness of similar treatments, such as CAR T cell therapies targeting B-cell maturation antigen (BCMA), which have shown dramatic remissions in patients with highly refractory multiple myeloma. This suggests that CC-95266, if it shares similar mechanisms, could potentially be effective as well. ^{1 2 3 4 5}

How is the treatment CC-95266 different from other treatments for multiple myeloma?

CC-95266 is a chimeric antigen receptor (CAR) T-cell therapy that targets the B-cell maturation antigen (BCMA), which is commonly found in multiple myeloma cells. This treatment is unique because it involves genetically modifying a patient's own T cells to specifically attack and destroy cancerous cells, offering a novel mechanism of action compared to traditional chemotherapy or other standard treatments. ^{6 7 8 9 10}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

This criterion refers to people who currently have or have had certain medical conditions in the past.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Progress and Paradigms in Multiple Myeloma. [2018]

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

High-dose therapy and innovative approaches to treatment of multiple myeloma. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

[Progress in the treatment of multiple myeloma]. [2015]

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

Hematologic Malignancies: Plasma Cell Disorders. [2019]

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

Post-infusion Costs Associated with Idecabtagene Vicleucel Treatment for Patients with Relapsed/Refractory Multiple Myeloma in the KarMMa Trial. [2023]

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

T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. [2022]

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

Novel human multiple myeloma cell line UHKT-893. [2013]

8. England 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. [2022]

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

Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. [2021]

10. United States 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. [2019]