Study of CLR 131 in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia
- 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]
- 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]
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
Cellectar Biosciences, Inc.
- Primary ID DCL-16-001
- Secondary IDs NCI-2017-01758
- Clinicaltrials.gov ID NCT02952508