* Phase 2 Study of CLR 131 in R/R B-Cell Malignancies with WM Expansion
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)
IRAS ID
292394
Contact name
Shirley D'Sa
Contact email
s.d'sa@nhs.net
Sponsor organisation
Cellectar Biosciences, Inc.
Eudract number
2020-005297-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 14 days
Research summary
B-cell malignancies represent a diverse collection of diseases and, taken together, make up the majority of haematologic malignancies (cancers of the blood, bone marrow and lymph nodes). B-cell lymphomas represent the largest percentage of these neoplasms, and the relapsed and/or refractory (R/R) B-cell lymphomas have proven very difficult to treat and remain an area of a significant unmet medical need.
CLOVER-1 is a two-part, non-randomised, open-label, multicentre study evaluating intravenous (IV) administration of CLR 131 in patients with B-cell malignancies who have been previously treated with standard therapy for their underlying malignancy. This study has two-parts: Part A was a basket trial study conducted in patients with R/R select B-cell malignancies. Part B (CLOVER-WaM) will evaluate the safety and efficacy of IV administration of CLR 131 in patients with Waldenstrom’s Macroglobulinemia (WM), a subset of Lymphoplasmacytic lymphoma (LPL). The UK will take part in Part B only.
CLR 131 is a radioactive pharmaceutical designed to target delivery of radiation to malignant tumour cells, thus minimising radiation exposure to normal tissues. CLR 131 will be administered in two cycles. A cycle is defined as two infusion doses provided 14 days apart. Cycle 2 shall be given 8 weeks following the initial infusion. Participants will be observed regularly until 57 days after the last CLR 131 infusion.
The primary objective of Part B is to determine the major response rate (MRR) of CLR 131 in patients with WM who have received first line standard of care and had a sub-optimal response to or failed treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
Approximately 50 WM patients will participate in Part B of the study. The study is sponsored by Cellectar Biosciences, Inc.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0194
Date of REC Opinion
26 Mar 2021
REC opinion
Further Information Favourable Opinion