18 Participants Needed

CYAD-211 Immunotherapy for Multiple Myeloma

(IMMUNICY-1 Trial)

Recruiting at 6 trial locations
CO
Overseen ByCelyad Oncology Medical Monitor, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of the IMMUNICY-1 study is to assess the safety, activity and cell kinetics of CYAD-211 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen with fludarabine and/or cyclophosphamide

Will I have to stop taking my current medications?

The trial requires that you stop any prior systemic therapy for multiple myeloma at least 14 days before starting the preconditioning chemotherapy.

What data supports the effectiveness of the treatment CYAD-211 for multiple myeloma?

Research on similar treatments, like CAR T-cell therapies targeting BCMA, shows potential in treating multiple myeloma by inducing high response rates in patients with relapsed or refractory disease.12345

Is CYAD-211 immunotherapy generally safe for humans?

Immunotherapy treatments like CYAD-211, which involve CAR T cells, have shown manageable safety profiles in clinical trials for multiple myeloma. Common side effects include cytokine release syndrome (a reaction where the immune system releases too many proteins into the blood too quickly) and neurotoxicity (nerve damage), but these are often mild and can be managed with medications.678910

How is the CYAD-211 treatment different from other treatments for multiple myeloma?

CYAD-211 is a type of CAR T-cell therapy, which is a form of immunotherapy that uses genetically engineered T-cells to target and destroy cancer cells. This approach is unique because it involves modifying a patient's own immune cells to specifically attack multiple myeloma cells, potentially offering a more targeted and effective treatment compared to traditional therapies.2341112

Eligibility Criteria

This trial is for adults with multiple myeloma that has come back or hasn't responded to at least two treatments, including IMiD and PIs. Participants must have measurable disease, be in decent physical shape (ECOG ≤2), and have good organ function. They can't join if they've had recent cancer treatment, CNS tumor involvement, a stem cell transplant too close to the study start date, or no response to previous BCMA-targeted therapy.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.
My multiple myeloma has not responded to at least two treatments, including IMiD and PIs.
My blood, kidney, liver, lung, and heart functions are all within normal ranges.
See 1 more

Exclusion Criteria

I have had BCMA-targeted therapy without significant improvement.
I have or had a brain tumor that affects my health.
I had my own stem cell transplant less than 3 months ago or a donor's within the last 6 months.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning Chemotherapy

Participants receive a non-myeloablative preconditioning chemotherapy regimen with fludarabine and/or cyclophosphamide

1-2 weeks

Treatment

Participants receive an infusion of CYAD-211 (anti-BCMA CAR-T) cells

Up to 36 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • CYAD-211
Trial OverviewThe IMMUNICY-1 study is testing CYAD-211's safety and effectiveness after patients receive lymphodepletion drugs Fludara (fludarabine) and/or Endoxan (cyclophosphamide). It aims to understand how this new therapy behaves in the body of those with relapsed/refractory multiple myeloma.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CYAD-211Experimental Treatment3 Interventions
Infusion post preconditioning non-myeloablative chemotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celyad Oncology SA

Lead Sponsor

Trials
13
Recruited
1,300+

Findings from Research

Novel agents like immunomodulatory drugs (IMiDs) and proteasome inhibitors (such as bortezomib) have significantly improved treatment outcomes for myeloma, showing better responses when used in combination with steroids and chemotherapy.
These therapies, initially used for relapsed or refractory myeloma, are now being tested in newly diagnosed patients, leading to higher response rates and longer-lasting effects.
Emerging therapies for multiple myeloma.Dingli, D., Rajkumar, SV.[2009]
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.
Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma.Raje, N., Berdeja, J., Lin, Y., et al.[2021]
In a phase II trial involving 69 patients with relapsed or refractory multiple myeloma, the combination of anti-BCMA and anti-CD19 CAR T cells resulted in a high overall response rate of 92%, with 60% achieving a complete response.
The treatment demonstrated a median progression-free survival of 18.3 months and a manageable safety profile, although 95% of patients experienced cytokine release syndrome, indicating the need for monitoring during treatment.
Long-Term Follow-Up of Combination of B-Cell Maturation Antigen and CD19 Chimeric Antigen Receptor T Cells in Multiple Myeloma.Wang, Y., Cao, J., Gu, W., et al.[2022]

References

Emerging therapies for multiple myeloma. [2009]
Cellular immunotherapy for plasma cell myeloma. [2018]
Immunotherapy in Multiple Myeloma: Accelerating on the Path to the Patient. [2020]
Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. [2021]
Long-Term Follow-Up of Combination of B-Cell Maturation Antigen and CD19 Chimeric Antigen Receptor T Cells in Multiple Myeloma. [2022]
Prevention and management of adverse events during treatment with bispecific antibodies and CAR T cells in multiple myeloma: a consensus report of the European Myeloma Network. [2023]
Current developments in immunotherapy in the treatment of multiple myeloma. [2019]
Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial. [2023]
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of multiple myeloma. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to other BCMA-targeting agents. [2023]
Monoclonal antibodies as an addition to current myeloma therapy strategies. [2021]
Identification and characterization of HLA-A24-specific XBP1, CD138 (Syndecan-1) and CS1 (SLAMF7) peptides inducing antigens-specific memory cytotoxic T lymphocytes targeting multiple myeloma. [2019]