Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma IMMUNICY-1

What's 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.

This trial is currently open and accepting patients.


You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  1. Documented diagnosis of MM with relapsed or refractory disease to at least two prior MM treatment regimens which should include exposure to IMiD and PIs either alone or in combination.
  2. Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
  3. Eastern Cooperative Oncology Group (ECOG) below or equal 2
  4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

  1. History or presence of clinically relevant central nervous system (CNS) pathology.
  2. Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
  3. Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
  4. Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
  5. Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.

Additional Trial Information

Phase 1

Enrollment: 12 patients (estimated)

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Published Results

Celyad Oncology Presents Preliminary Data from Phase 1 IMMUNICY-1 Trial of shRNA-based Allogeneic CAR T Candidate CYAD-211 in Relapsed/Refractory Multiple Myeloma at the European Hematology Association Virtual Congress

June 11, 2021

Safety and tolerability data:

Of the six patients dosed at the first two dose levels (30×106 and 100×106 cells per infusion):

  • No dose limiting toxicity (DLT), Graft-versus Host disease (GvHD) or CAR T-cell-related encephalopathy syndrome (CRES) were observed in the first two dose cohorts.
  • One cytokine release syndrome (CRS) Grade 1 (fever) requiring hospitalization occurred 10 days post CYAD-211 administration in patient 1 (dose level 1) who achieved a partial response (PR).
  • One patient experienced an anemia adverse event (Grade 3) and neutropenia (Grade 4) possibly related to CYAD-211.

Clinical activity:

Of the five evaluable patients at the first two dose levels (30×106 and 100×106 cells per infusion):

  • Two patients achieved a PR. Both patients were ‘triple-therapy exposed’ (previously treated with an immunomodulator (IMiD), a proteasome inhibitor and an anti-CD38 antibody).
  • The three additional patients had stable disease (SD).

Cell kinetics:

  • CYAD-211 cells were detected by PCR-based methods in all six patients from dose cohorts 1 and 2.
  • Cell engraftment was seen in all three patients at dose level 2 at a similar magnitude. In addition, preliminary data suggest that all patients in dose level 2 showed deep lymphodepletion. Across dose level 1, the depth of lymphodepletion appears to correlate with the degree of observed systemic CAR T engraftment.

Next steps:

  • Enrollment in dose cohort 3 (300×106 cells per infusion) is ongoing.
  • Additional clinical data from the dose escalation trial are expected during second half 2021.
  • shRNA technology platform to be highlighted at upcoming virtual R&D Day in Q3 2021.

Trial Locations

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Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

New York

Trial Links

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