alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells

Launched by CELYAD ONCOLOGY SA · Oct 1, 2018

Keywords

ClinConnect Summary

The alloSHRINK clinical trial is studying a new treatment for patients with advanced colorectal cancer that cannot be surgically removed. This trial combines standard chemotherapy with a special type of immunotherapy using CYAD-101, a type of engineered immune cell therapy. The main goals are to see how safe this treatment is, how well it works in the body, and whether it helps improve patients' health after they have already received other treatments.

To participate in this trial, patients should have a confirmed diagnosis of metastatic colorectal cancer that is not responding to previous treatments. They also need to have certain health conditions, such as good overall health and functioning organs. Participants can expect to receive the new treatment after undergoing standard chemotherapy, and they will be closely monitored for any side effects and how their cancer responds. It’s important to note that patients with brain tumors or those who have had specific previous therapies may not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically proven metastatic adenocarcinoma of the colon or rectum.
• • 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:
• • 1. The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
• • 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.