NCT03692429RecruitingPhase 1
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
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
Source: ClinicalTrials.gov · Last updated 20 Nov 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- First submitted
- 31 Aug 2018
- Start date
- 28 Nov 2018
- Primary completion date
- 28 Nov 2021
- Lead sponsor
- Celyad Oncology SA
- Diseases
- Colorectal cancer
- NCT number
- NCT03692429
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 49
- From 28 Nov 2018 to the primary completion date, 28 Nov 2021
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Moffit Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.