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

Trial Status: Active

Part A of this study evaluates 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), and diffuse large B-cell lymphoma (DLBCL) 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 CLR 131 in patients with WM that failed Bruton's tyrosine kinase inhibitors (BTKi).

Inclusion Criteria

  • Histologically or cytologically confirmed WM. Patients with a diagnosis of LPL may be enrolled with prior Sponsor approval.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (Appendix C)
  • Patient is 18 years of age or older
  • Life expectancy of at least 6 months
  • Received first line standard of care
  • Failed treatment with a BTK inhibitor or had a sub-optimal response to it. [CLOVER-WaM]

Exclusion Criteria

  • Ongoing Grade 2 or greater toxicities due to previous therapies. Stable, tolerable Grade 2 AEs (eg, neuropathy) may be allowed.
  • Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy.
  • Prior total body or hemi-body irradiation. Patients who have received prior low-dose total body or hemi-body irradiation may be allowed on a case-by-case basis after discussion with Sponsor (considerations may include factors such as time since irradiation, total lifetime accumulated dose, etc.)
  • Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon the spinal cord
  • Central nervous system involvement unless previously treated with surgery or radiotherapy with the patient neurologically stable and off corticosteroids
  • For patients with CLL/SLL, LPL, or MZL, transformation to a more aggressive form of NHL
  • Ongoing chronic immunosuppressive therapy
  • Clinically significant bleeding event within prior 6 months
  • Ongoing anti-platelet therapy (except low-dose aspirin [eg, 81 mg daily] for cardioprotection)
  • Anti-cancer therapy within two weeks of initial CLR 131 infusion. Low dose dexamethasone for symptom management is allowed
  • Radiation therapy, chemotherapy, immunotherapy, or investigational therapy within 2 weeks of eligibility-defining bone marrow biopsy. [CLOVER-WaM]

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

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. Success rate, defined as complete or partial response, is as low as 2% to

4% in many of these diseases, and they remain an area of a significant unmet medical need.

Patients that have failed BTKi, including WM patients, represent a very challenging patient

population with significantly reduced life-expectancy.

CLR 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. CLR 131

has been evaluated in over 80 xenograft and spontaneous (transgenic) tumor models where it

was demonstrated to be effective in eliminating tumors.

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 CLR 131 in a pivotal expansion cohort in Waldenstrom's Macroglobulinemia patients that

have failed BTKi treatment.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Cellectar Biosciences, Inc.

  • Primary ID DCL-16-001
  • Secondary IDs NCI-2017-01758
  • Clinicaltrials.gov ID NCT02952508