A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03018405
• Date of registration: 10/01/2017
• Prospective Registration: No
• Primary sponsor: Celyad Oncology SA
• Public title: A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications THINK
• Scientific title: A Multi-national, Open-label, Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Administrations of NKR-2 in Patients With Different Metastatic Tumor Types (THINK - THerapeutic Immunotherapy With NKR-2)
• Date of first enrolment: December 2016
• Target sample size: 146
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03018405
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium, United States

Contacts

• Name: Amélie Vanneste

• Name: Frédéric Lehmann, MD
• Affiliation: Celyad Oncology SA

Key inclusion & exclusion criteria

Main inclusion criteria are:

- Men or women = 18 years old at the time of signing the ICF,

- Patient with a CRC, epithelial ovarian cell or fallopian tube carcinoma, urothelial
carcinoma, TNBC, pancreatic cancer, AML/MDS or MM,

- Disease must be measurable according to the corresponding guidelines,

- Patient with an ECOG performance status 0 or 1, and AML patients with anemia resulting
in an ECOG performance status of 2,

- Patient with adequate bone marrow reserve, hepatic and renal functions.

- Patients must have sufficient pulmonary functions with a Forced Expiratory Volume in
the first second (FEV-1)/Forced Vital Capacity (FVC) = 0.7 with FEV-1 = 50% predicted.

Main exclusion criteria are:

- Patient with a tumor metastasis in the central nervous system,

- Patients who have received another cancer therapy within 2 weeks before the planned
day for the apheresis (except hydroxyurea for AML patients),

- Patients who receive or are planned to receive any other investigational product
within the 3 weeks before the planned day for the first NKR-2 administration (except
hydroxyurea for AML patients),

- Patient is under systemic immunosuppressive drugs, unless specific cases authorized
per protocol,

- Patients who have received other cell therapies,

- Patients who underwent major surgery within 4 weeks before the planned day for the
first NKR-2 administration.

- Patient cannot present with history of idiopathic pulmonary fibrosis, organizing
pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute
exacerbation of chronic obstructive pulmonary disease (COPD).

Detailed disease specific criteria exist and can be discussed with contacts listed below.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma (MM)

Acute Myeloid Leukemia/Myelodysplastic Syndrome

Intervention(s)

Biological: NKR-2 cells

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NKR-2 infusion [Time Frame: 24 months]

Secondary Outcome(s)

Clinical activity of the treatment in each tumor type [Time Frame: 24 months]

Secondary ID(s)

CYAD-N2T-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors