Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL

Not Recruiting

Trial ID: NCT02580552


Objectives of this clinical trial are to evaluate the safety, tolerability, pharmacokinetics and potential efficacy of the investigational drug, cobomarsen (MRG-106), in patients diagnosed with certain lymphomas and leukemias, including cutaneous T-cell lymphoma (CTCL) [mycosis fungoides (MF) subtype], chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL) [activated B-cell (ABC) subtype], and adult T-cell leukemia/lymphoma (ATLL). Cobomarsen is an inhibitor of a molecule called miR-155 that is found at high levels in these types of cancers and may be important in promoting the growth and survival of the cancer cells. Participants in the clinical trial will receive weekly doses of cobomarsen administered by injection under the skin or into a vein, or by injection directly into cancerous lesions in the skin (for CTCL only). Blood samples will be collected to measure how cobomarsen is processed by the body, and other measurements will be performed to study how normal and cancerous cells of the immune system respond when exposed to cobomarsen.

Official Title

A Phase 1 Dose-ranging Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MRG-106 Following Local Intratumoral, Subcutaneous, and Intravenous Administration in Subjects With Various Lymphomas and Leukemias

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


Inclusion Criteria:

   - Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III
   (excluding visceral or nodal involvement), and must be refractory to or intolerant of
   established therapies for their condition

   - Part D only: Patients diagnosed with CLL who are intolerant to, or have disease that
   is relapsed/refractory after, at least two prior therapies

   - Part E only: Patients with biopsy-proven DLBCL who are intolerant to, or have disease
   that is relapsed/refractory after, at least two prior therapies, including any
   anti-CD20 monoclonal antibody and chemotherapy with curative intent

   - Part F only: Patients with documented HTLV-1 infection and histologically or
   cytologically proven ATLL of any stage, and who are intolerant to, or have disease
   that is relapsed/refractory after, at least one prior therapy

   - Females must not be pregnant or lactating. Women of child-bearing potential must use a
   highly effective method of contraception throughout their study participation and for
   at least 6 months following the last dose of study drug.

   - Males must be surgically sterile, abstinent, or if engaged in sexual relations with a
   female of child-bearing potential, must be willing to use a highly effective method of
   contraception throughout their study participation and for at least 6 months after the
   last dose of study drug.

Exclusion Criteria:

   - Evidence of renal or liver dysfunction at screening

   - Clinically significant anemia, neutropenia or thrombocytopenia at screening

   - History of bleeding diathesis or coagulopathy

   - Clinically significant cardiovascular disease, history of myocardial infarction within
   the last 6 months, or evidence of QTc interval prolongation at screening

   - Serologically positive for HIV; serologically positive for Hepatitis B or Hepatitis C
   with evidence of liver dysfunction or documented liver cirrhosis

   - Prior malignancies within the past 3 years (with allowance for adequately treated in
   situ carcinoma of the cervix uteri, and basal cell or localized squamous cell
   carcinoma of the skin treated with curative intent)

   - Use of an investigational small molecule drug during the 30 days prior to screening or
   use of an investigational oligonucleotide or biologic drug during the prior 90 days


drug: Cobomarsen

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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