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

NCT ID: NCT04613557

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2037-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Relapse/Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYAD-211

Infusion post preconditioning non-myeloablative chemotherapy

Group Type EXPERIMENTAL

CYAD-211

Intervention Type BIOLOGICAL

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

Endoxan

Intervention Type DRUG

Preconditioning chemotherapy

Fludara

Intervention Type DRUG

Preconditioning chemotherapy

Interventions

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CYAD-211

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

Intervention Type BIOLOGICAL

Endoxan

Preconditioning chemotherapy

Intervention Type DRUG

Fludara

Preconditioning chemotherapy

Intervention Type DRUG

Other Intervention Names

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cyclophosphamide Fludarabine

Eligibility Criteria

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Exclusion Criteria

1. History or presence of clinically relevant central nervous system (CNS) tumor involvement.
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celyad Oncology SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Nyu Langone Hospitals

New York, New York, United States

Site Status

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

AZ DELTA

Roeselare, , Belgium

Site Status

Countries

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United States Belgium

Other Identifiers

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CYAD-211-001

Identifier Type: -

Identifier Source: org_study_id

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