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

NCT04613557 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CYAD-211-001
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Relapse/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Occurrence of Dose Limiting Toxicities

  Occurrence of Dose Limiting Toxicities

  Up to 36 days post-infusion.

Study Arms (1)

CYAD-211

EXPERIMENTAL

Infusion post preconditioning non-myeloablative chemotherapy

Biological: CYAD-211; Drug: Endoxan; Drug: Fludara

Interventions

CYAD-211 BIOLOGICAL

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

CYAD-211

Endoxan DRUG

Preconditioning chemotherapy

Also known as: cyclophosphamide

CYAD-211

Fludara DRUG

Preconditioning chemotherapy

Also known as: Fludarabine

CYAD-211

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celyad Oncology SA: lead

Study Sites (5)

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Nyu Langone Hospitals

New York, New York, 10016, United States

Location

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

AZ DELTA

Roeselare, 8800, Belgium

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

Cyclophosphamide; fludarabine phosphate; fludarabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: November 16, 2020
• Primary Completion: December 21, 2022
• Study Completion (Estimated): February 1, 2037
• Last Updated: August 31, 2023

Record last verified: 2023-06

Locations

BE (3); US (2)