alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
NCT ID: NCT03692429
Last Updated: 2020-11-20
Study Results
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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RECRUITING
PHASE1
49 participants
INTERVENTIONAL
2018-11-28
2036-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CYAD-101 with FOLFOX
Infusion after standard FOLFOX chemotherapy
CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFOX
5-FU, leucovorin and oxaliplatin
CYAD-101 with FOLFIRI
Infusion after standard FOLFIRI chemotherapy
CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFIRI
5-FU, leucovorin and irinotecan
Interventions
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CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFOX
5-FU, leucovorin and oxaliplatin
FOLFIRI
5-FU, leucovorin and irinotecan
Eligibility Criteria
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Inclusion Criteria
1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
2. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
4. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
5. 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.
2. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
Exclusion Criteria
2. Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
3. Filgrastim (Granulocyte-Colony-Stimulating Factor \[G-CSF\]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
4. Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
18 Years
ALL
No
Sponsors
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Celyad Oncology SA
INDUSTRY
Responsible Party
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Locations
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Moffit Cancer Center
Tampa, Florida, United States
Institut Jules Bordet
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Kim Dae Won, MD
Role: primary
Michel Dubuisson
Role: primary
Hans Prenen, MD
Role: primary
Hilde Marsé
Role: primary
References
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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.
Other Identifiers
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CYAD-N2L-101
Identifier Type: -
Identifier Source: org_study_id