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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

May 31, 2021

Study Completion Date

August 31, 2021

Conditions
Acute Myeloid Leukemia/Myelodysplastic SyndromeMultiple Myeloma (MM)
Interventions
BIOLOGICAL

NKR-2 cells

"In cohorts 1-6, the schedule of administration will be 3 NKR-2 doses administered with a 2-week interval. In absence of progressive disease at the first tumor assessment following NKR-2 administration (on Visit D29 for hematological tumors or on Visit D57 for solid tumors), and according to product availability, the patient will receive a new cycle of 3 administrations maximum with a 2-week interval, at a dose of 1x109 NKR-2 cells per injection, or at the same dose of cycle 1 if it was below 1x109 NKR-2 cells.~Patients in cohorts 8-9 (solid arm) and 10-11 (hematological arm) of first segment will receive 3 treatment doses at 1x109 NKR-2 (cohorts 8 and 10) or 3x109 NKR-2 (cohorts 9 and 11) per injection, with a 1-week interval between each dose. A second cycle of three NKR-2 injections at the same dose as in 1st cycle will be administered 2 weeks after the third NKR-2 injection, and with a 2-week interval between each dose."

Trial Locations (5)

1200

RECRUITING

Brussels

14263

RECRUITING

Buffalo

33612

RECRUITING

Tampa

Unknown

RECRUITING

Brussels

RECRUITING

Ghent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celyad Oncology SA

INDUSTRY

NCT03018405 - A Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Cancer Indications | Biotech Hunter | Biotech Hunter