PHE885 CAR-T therapy in adults with r/r multiple myeloma
Research type
Research Study
Full title
A Phase 2 study of PHE885, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants with relapsed and refractory multiple myeloma
IRAS ID
1004417
Contact name
Christiane Fischer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-003747-22
Clinicaltrials.gov Identifier
Research summary
A study to find out if a CAR T-cell therapy (PHE885) is safe and effective and can help people who have relapsed (comes back after treatment) and refractory (does not go away with treatment) multiple myeloma. \n\nAbout 100 adults with multiple myeloma that were not responding to the previous treatment and where the disease has returned (refractory and relapsed) will take part.\n\nTo make PHE885, a participant’s own T-cells will be taken by taking blood. Their blood will then be given back to them after the T-cells are taken out. These T-cells will be changed to teach them how to find and kill cancer cells. These changed cells are PHE885. \n\nOne dose of PHE885 will be given as a onetime injection administered into the vein. More chemotherapy may be given before PHE885.\n\nThis is the second study that PHE885 will be tested in humans and its effectiveness is yet unknown.\n\nParticipants will need to visit the hospital about 23 times. \nParticipants will remain in, or close to the hospital for at least 4 weeks after PHE885 is given.\nFollowing the PHE885 injection (Day 1) participants will visit the hospital on Day 2, Day 4, Day 7, Day 11, Day 14, Day 17, Day 21 and Day 28. After the Day 28 visit, every month for the first 6 months, and then every 3 to 6 months.\n\nParticipants may be in the study for about 40 months and may then take part in another study for up to 15 years.\n\nTaking part in this research study may not benefit participants directly, but the Sponsor may learn new things that could help treat patients with multiple myeloma in the future.\n\nThe study is organised/funded by Novartis Pharma AG and run by medical staff in hospital.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0217
Date of REC Opinion
5 May 2022
REC opinion
Further Information Favourable Opinion