Actively Recruiting
Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Led by SIRPant Immunotherapeutics, Inc. · Updated on 2024-12-20
24
Participants Needed
3
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to test SIRPant-M (RB-1355) , an autologous cell therapy, alone or in combination with focal external-beam radiotherapy in participants with relapsed or refractory non-Hodgkin's lymphoma (NHL). Two dose levels of SIRPant-M are being tested. The main question this study aims to answer is if SIRPant-M alone or in combination with radiotherapy is safe and well-tolerated.
CONDITIONS
Official Title
Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 18 years or older able to provide informed consent
- Diagnosis of relapsed or refractory non-Hodgkin's lymphoma confirmed by histology or cytology
- Received at least two lines of systemic therapy and ineligible or inappropriate for curative treatments
- Have at least one accessible lymph node or cutaneous/subcutaneous lesion 1.5 to 5 cm in size, suitable for intratumoral injection and not previously irradiated
- Life expectancy greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Hemoglobin above 8 g/dL, absolute neutrophil count above 500/mm3, monocyte count at least 200/µL, and platelets above 50,000/µL
- Adequate liver and kidney function including ALT and AST less than 3 times the upper limit of normal (except if due to leukemic involvement), creatinine clearance at least 60 mL/min, and bilirubin less than 1.5 times upper limit of normal (unless Gilbert's syndrome)
- Cardiac function classified as American Heart Association class 1 without significant limitations
- Not pregnant with negative pregnancy test if of reproductive potential
- Agree to use effective contraception during the study and for 90 days after treatment
- Willing and able to comply with study procedures including treatment, biopsies, visits, and follow-up
You will not qualify if you...
- Prior intratumoral injection therapy
- Received autologous stem cell transplant or cellular therapy including CAR-T within 1 month, or allogeneic stem cell transplant within 6 months with active graft-versus-host disease or immunosuppression
- Received systemic anti-cancer therapy within 14 days before study treatment
- Received interleukin-2 therapy within the last 6 months
- Have acquired immune defects such as HIV infection
- Uncontrolled hypertension (systolic >180 mmHg or diastolic >100 mmHg)
- Diagnosis of unclassifiable B-cell lymphoma
- Bleeding disorders or abnormal clotting parameters with INR greater than 1.5 times normal
- Receiving antiplatelet drugs that increase risk with intratumoral injections
- Pulmonary disease impairing respiratory tolerance to fluid overload
- Known alcohol or drug abuse
- Received investigational agent within 30 days before study treatment
- Chronic prednisone therapy at doses ≥10 mg/day or other immunosuppressive therapy
- Active central nervous system tumors or metastases
- Not eligible for 2.5 Gy x3 focal external-beam radiation if applicable
- Uncontrolled active viral hepatitis B, C, or D infections
- Received live vaccine within 4 weeks before baseline
- Active uncontrolled autoimmune disease or high-risk autoimmune disease history
- Other serious medical, psychiatric, or uncontrolled illness interfering with study adherence
- Active systemic infection confirmed at Day 1 prior to treatment
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jelle Kijlstra, MD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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