Unresectable Metastatic Colorectal CancerPhase 1alloSHRINKNCT03692429
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
A Phase 1 study testing CYAD-101, FOLFOX and FOLFIRI in people with Unresectable Metastatic Colorectal Cancer, run by Celyad Oncology SA at 4 sites in 2 countries.
Trial summary
The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Metastatic Colorectal Cancer
- What is being tested?
- CYAD-101, FOLFOX and FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Nov 2018to 17 Feb 2036
- 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
- Histologically proven metastatic adenocarcinoma of the colon or rectum.
- Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
- Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
- Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
- FOLFIRI segment: Documented progressive disease (PD) under FOLFIRI treatment, with or without targeted therapy, given within 3 months prior to study registration. Anti-cancer therapy post FOLFIRI-documented PD prior to study registration is authorized if discontinued at least 7 days before the planned study registration. Radiotherapy is not authorized.
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Who cannot join
- The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
- Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
- Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
- Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Belgium3 sites, 3 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1000
Michel Dubuisson
Alain Hendlisz, MD
- Recruiting
UZ Antwerpen
Edegem, 2650
Hans Prenen, MD
Hans Prenen, MD
- Recruiting
UZ Leuven
Leuven, 3000
Hilde Marsé
Eric Van Cutsem, MD
United States1 site, 1 recruiting
- Not yet recruiting
Moffit Cancer Center
Tampa, Florida, 33612
Kim Dae Won, MD
Kim Dae Won
About this study
Official title: An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer
The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy
Read the detailed description
This Study aims to determine and confirm the recommended dose of the allogeneic CYAD-101 cells after standard FOLFOX or FOLFIRI chemotherapy in patients with unresectable metastatic colorectal cancer
- Being tested
- CYAD-101, FOLFOX, FOLFIRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYAD-101Drug
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFOXDrug
5-FU, leucovorin and oxaliplatin
FOLFIRIDrug
5-FU, leucovorin and irinotecan
| Study group | Role | What they receive |
|---|---|---|
| CYAD-101 with FOLFOX | Experimental | Infusion after standard FOLFOX chemotherapy Receives: Drug: CYAD-101; Drug: FOLFOX |
| CYAD-101 with FOLFIRI | Experimental | Infusion after standard FOLFIRI chemotherapy Receives: Drug: CYAD-101; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Dose Limiting Toxicities
Measured: Up to 82 days post first CYAD-101 Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start28 Nov 2018
- Primary completion28 Nov 2021 (estimated)
- Study completion17 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Metastatic Colorectal CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celyad Oncology SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692429
- Sponsor's protocol ID
- CYAD-N2L-101
- Acronym
- alloSHRINK
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michaux A, Mauen S, Breman E, Dheur MS, Twyffels L, Saerens L, Jacques-Hespel C, Gauthy E, Agaugue S, Gilham DE, Sotiropoulou PA. Clinical Grade Manufacture of CYAD-101, a NKG2D-based, First in Class, Non-Gene-edited Allogeneic CAR T-Cell Therapy. J Immunother. 2022 Apr 1;45(3):150-161. doi: 10.1097/CJI.0000000000000413.
PubMed 35191428
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03692429
- Acronym / sponsor ID
- alloSHRINK / CYAD-N2L-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Celyad Oncology SAIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 28 Nov 2021 (estimated)
- Study completion
- 17 Feb 2036 (estimated)
- First posted
- 2 Oct 2018 (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 alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy
Detailed description
This Study aims to determine and confirm the recommended dose of the allogeneic CYAD-101 cells after standard FOLFOX or FOLFIRI chemotherapy in patients with unresectable metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYAD-101 with FOLFOX | Experimental | Drug: CYAD-101, Drug: FOLFOXInfusion after standard FOLFOX chemotherapy |
| CYAD-101 with FOLFIRI | Experimental | Drug: CYAD-101, Drug: FOLFIRIInfusion after standard FOLFIRI chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven metastatic adenocarcinoma of the colon or rectum.
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Key exclusion criteria (4 listed)
- The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
- Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
- Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
- Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
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-101Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells | Drug | CYAD-101 with FOLFIRI, CYAD-101 with FOLFOX |
| FOLFOX5-FU, leucovorin and oxaliplatin | Drug | CYAD-101 with FOLFOX |
| FOLFIRI5-FU, leucovorin and irinotecan | Drug | CYAD-101 with FOLFIRI |
Primary outcome
Occurence of Dose Limiting Toxicities
Time frame: Up to 82 days post first CYAD-101 Infusion
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 20 Nov 2020.
- Derived from this study: PubMed 35191428Michaux A, Mauen S, Breman E, Dheur MS, Twyffels L, Saerens L, Jacques-Hespel C, Gauthy E, Agaugue S, Gilham DE, Sotiropoulou PA. Clinical Grade Manufacture of CYAD-101, a NKG2D-based, First in Class, Non-Gene-edited Allogeneic CAR T-Cell Therapy. J Immunother. 2022 Apr 1;45(3):150-161. doi: 10.1097/CJI.0000000000000413.
- Individual participant dataSharing planned: No
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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.
4 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-101, FOLFOX and FOLFIRI in people with Unresectable Metastatic Colorectal Cancer, run by Celyad Oncology SA at 4 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Contact Celyad Oncology Medical Monitor, MD, PhD (+3210394100, clinicaltrials@celyad.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Dose Limiting Toxicities (time frame: Up to 82 days post first CYAD-101 Infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692429, which also lists 1 linked publication.
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 20 Nov 2020.