Buscador de ensayos clínicos

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CYAD-101 (Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells; CAR-T cells immunotherapy) plus FOLFOX (chemo, standard of care- which contains 5-FU, leucovorin and oxaliplatin) plus Pembrolizumab.

Pembrolizumab (Keytruda), is a humanized antibody used in cancer immunotherapy (anti PD-1) that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, and cervical cancer.

Locations: Moffit Cancer Center in Tampa, Fl and Emory University in Atlanta, Georgia and 3 universities in Belgium

Key Inclusion Criteria:
1. Histologically proven metastatic adenocarcinoma of the colon or rectum.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Adequate organ, hepatic, renal, pulmonary and cardiac functions
4. Tumor biopsy at screening

Key Exclusion Criteria:
1. Any other investigational agent or device within 4 weeks of the first study treatment administration.
2. Any anticancer agent within 4 weeks of the first study treatment administration Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days of the first study treatment administration
3.Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
4. Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
5. Major surgery within 4 weeks before the planned day for the first study treatment administration
6. A live vaccine within 30 days prior to the planned day for the first study treatment administration
7. Uncontrolled intercurrent illness or serious uncontrolled medical disorder
8. Patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.

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Criterios de inclusión

Criterios de inclusión:

Adenocarcinoma metastásico de colon o recto histológicamente probado.

Adenocarcinoma metastásico no resecable confirmado de colon o recto.
Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
Enfermedad inequívoca y medible según los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST versión 1.1).
Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
The patient is due to receive FOLFOX chemotherapy
Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Adequate organ, hepatic, renal, pulmonary and cardiac functions
Tumor biopsy at screening

Key

Criterios de exclusión

Criterios de exclusión:

Any other investigational agent or device within 4 weeks of the first study treatment administration.
Any anticancer agent within 4 weeks of the first study treatment administration
Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days of the first study treatment administration
Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
Major surgery within 4 weeks before the planned day for the first study treatment administration
A live vaccine within 30 days prior to the planned day for the first study treatment administration
Uncontrolled intercurrent illness or serious uncontrolled medical disorder
Patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.