Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2038-05-25

Brief Summary

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The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.

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Detailed Description

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This Study aims to provide insight into whether CYAD-101 administration concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment might be a treatment option for patients with unresectable metastatic colorectal cancer

Conditions

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Unresectable Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab

Group Type EXPERIMENTAL

CYAD-101

Intervention Type DRUG

Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

FOLFOX

Intervention Type DRUG

5-FU, leucovorin and oxaliplatin

Pembrolizumab

Intervention Type DRUG

Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

Interventions

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CYAD-101

Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

Intervention Type DRUG

FOLFOX

5-FU, leucovorin and oxaliplatin

Intervention Type DRUG

Pembrolizumab

Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically proven metastatic adenocarcinoma of the colon or rectum.

1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
2. Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
4. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
5. The patient is due to receive FOLFOX chemotherapy
6. Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
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

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
3. Filgrastim (Granulocyte-Colony-Stimulating Factor \[G-CSF\]) or similar growth factors within 7 days of the first study treatment administration
4. 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
5. Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
6. Major surgery within 4 weeks before the planned day for the first study treatment administration
7. A live vaccine within 30 days prior to the planned day for the first study treatment administration
8. Uncontrolled intercurrent illness or serious uncontrolled medical disorder
9. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No