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Clinical Trial Summary

This phase I trial identifies the best dose and side effects of CpG-STAT3 siRNA CAS3/SS3 (CAS3/SS3) in combination with localized radiation therapy in treating patients with B-cell non-Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory). CAS3/SS3 simultaneously targets two molecules, TLR9 receptor and STAT3. This investigational drug combines a CpG oligonucleotide and an siRNA in one molecule that act together to interfere with the ability of the cancer cells to grow. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving CAS3/SS3 with localized radiation therapy may kill more cancer cells.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Determine the recommended phase 2 dose (RP2D) of CAS3/SS3 when given in combination with local fixed-dose radiation therapy (RT). II. Evaluate the safety and feasibility of intratumoral injections of CAS3/SS3 when combined with local fixed-dose RT, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. SECONDARY OBJECTIVES: I. Characterize the clinical activity (overall and per dose level) of CAS3/SS3 through the assessment of disease response, and response duration. (Clinical) II. Characterize the biologic activity (overall and per dose level) of CAS3/SS3 when combined with local fixed-dose RT by assessing. (Biologic [Immunologic Correlative Studies]) IIa. Silencing of the STAT3 gene and its key downstream genes. IIb. Local and systemic immune responses, including: evidence/extent of immune cell intratumoral infiltration, immune cell activation within the tumor and in the peripheral blood, and changes in proinflammatory mediators in plasma. OUTLINE: Patients undergo radiation therapy on days 1 and 2 tumor-bearing lymph node, and receive CAS3/SS3 intratumorally on days 2, 4, 16, and 18. Patients assigned to dose level 3 also receive CAS3/SS3 intratumorally on days 9, 11, 23, and 25. After completion of study treatment, patients are followed up every 3 months. ;


Study Design


Related Conditions & MeSH terms

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Recurrence
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Grade 3a Follicular Lymphoma
  • Recurrent Grade 3b Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Grade 1 Follicular Lymphoma
  • Refractory Grade 2 Follicular Lymphoma
  • Refractory Grade 3 Follicular Lymphoma
  • Refractory Grade 3a Follicular Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Small Lymphocytic Lymphoma

NCT number NCT04995536
Study type Interventional
Source City of Hope Medical Center
Contact
Status Withdrawn
Phase Phase 1
Start date July 27, 2021
Completion date January 4, 2024

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