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Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia

Cancer Type
Multiple Myeloma
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
DCL-16-001 (primary)
Study Sponsor
Cellectar Biosciences, Inc.


Part A of this study evaluates iopofosine I 131 (CLR 131) in patients with select B-cell
malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom
Macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse
large B-cell lymphoma (DLBCL), and central nervous system lymphoma (CNSL) who have been
previously treated with standard therapy for their underlying malignancy. Part B
(CLOVER-WaM) is a pivotal efficacy study evaluating IV administration of iopofosine I 131
in patients with WM that have received at least two prior lines of therapy.


B-cell malignancies represent a diverse collection of diseases and, taken together, make
up the majority of hematologic malignancies. B-cell lymphomas represent the largest
percentage of these neoplasms, and the relapsed and/or refractory B-cell lymphomas have
proven very difficult to treat. Patients that have failed prior therapy, including WM
patients, represent a very challenging patient population with significantly reduced

Iopofosine I 131 is a targeted radiotherapeutic that exploits the selective uptake and
retention of Cellectar's proprietary phospholipid ethers (PLEs) by malignant cells.
Cellectar Biosciences' novel cancer-targeted small-molecule compound is radiolabeled with
the radioisotope iodine-131 (I-131) which has previously been used approved for use in
select tumors. Iopofosine I 131 has been evaluated in over 80 xenograft and spontaneous
(transgenic) tumor models where it was demonstrated to be effective in eliminating

Based on the critical unmet medical need for effective agents with novel mechanisms of
action in B-cell malignancies, Cellectar Biosciences has chosen to expand this ongoing
study to assess iopofosine I 131 in a pivotal expansion cohort in Waldenstrom's
Macroglobulinemia patients that have received at least two prior lines of therapy.


  1. Histologically or cytologically confirmed WM. Patients with a diagnosis of LPL may be enrolled with prior Sponsor approval.
  2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (Appendix C)
  3. Patient is 18 years of age or older
  4. Life expectancy of at least 6 months
  5. Received at least two prior lines of therapy for WM
  6. Measurable IgM (above upper limit of normal) OR at least one measurable nodal lesion with longest diameter > 15 mm or one measurable extranodal lesion (e.g., hepatic nodule) with longest diameter > 10 mm [CLOVER-WaM]
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.