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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

Clinical Trial Details

This clinical trial is for women and men age 18 and older with HTLV-1 associated adult T-cell lymphoma/leukemia (ATLL). 

There is no standard of care for ATLL. For patients with aggressive disease, the most promising regimen studied in prospective phase 2 and 3 trials is VCAP-AMP-VECP (also known as LSG15), which includes treatment with vincristine, cyclophosphamide, doxorubicin, prednisone, ranimustine, vindesine, etoposide, and carboplatin. This regimen is associated with significant toxicity. Antiviral therapy (AZT plus interferon) has also been studied in small trials and retrospective analyses, suggesting some benefit. 

The primary objective of the study is to investigate the safety and tolerability of multiple subcutaneous or intravenous administration of MRG-106 in subjects with HTLV-1 associated adult T-cell leukemia/lymphoma (ATLL). 

A 14-day screening period will be used to determine eligibility. Length of treatment varies. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. 

Key Eligibility: 

For Part A: Intratumoral administration of MRG-106 

  • Biopsy proven CTCL, MF sub-type, clinical stage I, II, or III 
  • Subjects must have at least one tumor or plaque large enough to accommodate two locations for the following: 1) a pre-injection biopsy and 2) an injection site from which a biopsy will be taken post-treatment 
  • For subjects in Part A that are to be treated with study drug and saline control (by subject consent or as required by the sponsor), subjects must have at least two similar tumors or plaques, each large enough to accommodate two locations for the following: 1) a pre-injection biopsy and 2) an injection site from which a biopsy will be taken post-treatment 
  • Subjects have had no change in treatment regimen for CTCL, including drug and dose, for ≥ 4 weeks prior to enrollment
  • Subjects with large cell transformations can be enrolled 

For Part B: MRG-106 administered by various routes

  • Subjects must have biopsy proven CTCL, MF sub-type, clinical stage I, II, or III 
  • Subjects must have a mSWAT score of at least 5 at screening 
  • Subjects have had no change in treatment regimen for CTCL, including drug and dose, for ≥ 4 weeks prior to enrollment 
  • Subjects with large cell transformations can be enrolled 

For Part C: MRG-106 as monotherapy 

  • Subjects must have biopsy proven CTCL, MF sub-type, clinical stage I, II, or III 
  • Subjects must have a mSWAT score of at least 5 at screening 
  • Subjects must not have had previous treatment with MRG-106 
  • Subjects must have washed out of previous treatments for CTCL, as follows: Topical - 2 weeks; Radiation - 8 weeks; Systemic (unless antibody - 4 weeks; Antibody - 8 weeks
  • Subjects with large cell transformations can be enrolled 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1710018662

ClinicalTrials.gov:

NCT02580552

Sponsor:

MRG-106

Status

Open to Enrollment

Age Group

Adult

Sponsor