Trials / Withdrawn

WithdrawnNCT04995536

CpG-STAT3 siRNA CAS3/SS3 and Localized Radiation Therapy for the Treatment of Relapsed/Refractory B-Cell NHL

A Phase I Study of Intratumoral Injections of CpG-STAT3 siRNA (CAS3/SS3) in Combination With Local Radiation in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL)

Status: Withdrawn
Phase: Phase 1
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	CpG-STAT3 siRNA CAS3/SS3	Given intratumorally
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

Start date: 2021-07-27
Primary completion: 2024-01-04
Completion: 2024-01-04
First posted: 2021-08-09
Last updated: 2024-04-25

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04995536. Inclusion in this directory is not an endorsement.