Relapse/Refractory Multiple MyelomaPhase 1IMMUNICY-1NCT04613557
Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing CYAD-211, Endoxan and Fludara in people with Relapse/Refractory Multiple Myeloma, run by Celyad Oncology SA at 5 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapse/Refractory Multiple Myeloma
- What is being tested?
- CYAD-211, Endoxan and Fludara
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Nov 2020to Feb 2037
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium3 sites
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Institut Jules Bordet
Brussels, 1000
AZ DELTA
Roeselare, 8800
United States2 sites
Nyu Langone Hospitals
New York, New York, 10016
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official 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
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
Read the detailed description
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
- Relapse/Refractory Multiple Myeloma
- Being tested
- CYAD-211, Endoxan, Fludara
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYAD-211Biological
Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell
EndoxanDrug
Also called cyclophosphamide
Preconditioning chemotherapy
FludaraDrug
Also called Fludarabine
Preconditioning chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| CYAD-211 | Experimental | Infusion post preconditioning non-myeloablative chemotherapy Receives: Biological: CYAD-211; Drug: Endoxan; Drug: Fludara |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicities
Occurrence of Dose Limiting Toxicities
Measured: Up to 36 days post-infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start16 Nov 2020
- Primary completion21 Dec 2022
- Study completionFeb 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celyad Oncology SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613557
- Sponsor's protocol ID
- CYAD-211-001
- Acronym
- IMMUNICY-1
- Status last verified
- Jun 2023
- First submitted
- 28 Oct 2020
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04613557
- Acronym / sponsor ID
- IMMUNICY-1 / CYAD-211-001
- Conditions
- Relapse/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Celyad Oncology SAIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- Feb 2037 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CYAD-211 | Experimental | Biological: CYAD-211, Drug: Endoxan, Drug: FludaraInfusion post preconditioning non-myeloablative chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYAD-211Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell | Biological | CYAD-211 |
| EndoxanAlso: cyclophosphamidePreconditioning chemotherapy | Drug | CYAD-211 |
| FludaraAlso: FludarabinePreconditioning chemotherapy | Drug | CYAD-211 |
Primary outcome
Occurrence of Dose Limiting Toxicities
Time frame: Up to 36 days post-infusion.
Occurrence of Dose Limiting Toxicities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYAD-211, Endoxan and Fludara in people with Relapse/Refractory Multiple Myeloma, run by Celyad Oncology SA at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose Limiting Toxicities (time frame: Up to 36 days post-infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.