Actively Recruiting
Study of Autologous SIRP-alpha-low Macrophages (SIRPant-M) by Tumor Injection Alone or with External-Beam Radiotherapy in 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
Researchers are evaluating SIRPant-M (RB-1355), an autologous cell therapy, alone or combined with low-dose focal external-beam radiotherapy in adults with relapsed or refractory non-Hodgkin's lymphoma (NHL). This open-label phase 1 study aims to determine the safety and tolerability of SIRPant-M administered by intratumoral injection either as monotherapy or with radiotherapy. Eligible NHL types include both B-cell and certain T-cell lymphomas. SIRPant-M treatment involves three intratumoral injections given at two-day intervals per cycle, prepared from a single mononuclear apheresis. Three dose levels are studied: low (90 million cells), intermediate (300 million cells), and high (600 million cells), split over three injections. In combination cohorts, each injection is followed by 2.5 Gy focal radiation to the injected tumor, totaling 7.5 Gy. At the highest dose, alternate-day dosing is compared with weekly dosing. Patients with partial response or stable disease after the first cycle may receive a second cycle using frozen cells from the initial apheresis. Dose escalation follows a 3+3 design with ongoing safety reviews. Participants will undergo tumor biopsies, imaging scans, laboratory tests, and clinical evaluations throughout the study. Safety is monitored from 42 days before treatment through one year after. Researchers will track treatment-emergent adverse events and other safety outcomes. Participants must adhere to scheduled visits and procedures, including clinical assessments and follow-up, to evaluate the therapy's safety and tolerability over the course of the study.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here