CRSP-ONC-002 CTX120 in Relapsed or Refractory Multiple Myeloma
Research type
Research Study
Full title
A Phase 1 Dose Escalation and Cohort Expansion Study of Safety and Efficacy of Anti-BCMA Allogeneic CRISPR-Cas9–Engineered T Cells (CTX120) in Subjects With Relapsed or Refractory Multiple Myeloma
IRAS ID
273085
Contact name
Rakesh Popat
Contact email
Sponsor organisation
CRISPR Therapeutics AG
Eudract number
2019-002948-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 1 days
Research summary
Research Summary:
This study will evaluate the safety and efficacy, of CTX120 in patients with Multiple Myeloma (MM) that has relapsed or progressed.
Chimeric antigen receptor (CAR) T cells are a form of cancer immunotherapy that have been used in the treatment of certain blood cancers. CTX120 is made from allogeneic (healthy donor) T cells that have been modified with CRISPR/Cas9 gene editing.
This study will enrol male and female adult participants recruited form multiple global sites in various regions. There will be approximately 6 to 18 patients participating in Part A of the study. The study may be expanded to include approximately 70 additional patients in Part B. Participants will be enrolled in this study for approximately 5 years.
After completion of this study, all participants will be required to enter a separate long-term follow-up study for an additional 10 years to assess safety and survival.
Part A will assess the safety of increasing doses of CTX120 and will be used to determine the dose for Part B cohort expansion. Part B will assess the efficacy of CTX120 in relapsed or refractory MM.
During both Part A and Part B, the study will consist of 3 main stages: 1. Screening, 2A+B. Lymphodepleting chemotherapy and subsequent infusion of CTX120 and Stage 3.5 year follow up.Lay summary of study results:
26 patients with relapsed/refractory multiple myeloma were enrolled in Study CRSP-ONC-002 and treated with CTX120 at 5 different dose levels. CTX120 was well tolerated and there were no safety concerns. Partial responses were seen in 4 subjects.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/1085
Date of REC Opinion
1 Dec 2020
REC opinion
Further Information Favourable Opinion