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NCT Number: NCT04613557

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapse/Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitair Ziekenhuis Antwerpen, Antwerp, Belgium

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About this study

This study aims to determine the recommended dose of the allogeneic CYAD-211 (anti-BCMA CAR-T) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (MM) patients with relapsed or refractory disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
  • Eastern Cooperative Oncology Group (ECOG) below or equal 2
  • Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

Exclusion criteria

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

Treatment and study plan

CYAD-211

Biological

Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell

endoxan

Drug

Preconditioning chemotherapy

Other names: cyclophosphamide

Fludara

Drug

Preconditioning chemotherapy

Other names: Fludarabine

Primary outcomes

  1. Occurrence of Dose Limiting Toxicities

    Time frame: Up to 36 days post-infusion.

    Occurrence of Dose Limiting Toxicities

Sponsors and collaborators

Lead sponsor

Celyad Oncology SA

Industry

Registry information

Official study title

Open-label Phase I, Multi-center Study to Determine the Recommended Dose of CYAD-211 After a Non-myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients With Relapsed or Refractory Disease

Acronym: IMMUNICY-1

Important dates

Study start
2020
Primary completion
2022
Study completion
2037
First posted
Nov 3, 2020
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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