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CAR T-cell Therapy
SIRPant-M + Radiotherapy for Non-Hodgkin's Lymphoma
Phase 1
Recruiting
Research Sponsored by SIRPant Immunotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -42 through day 364
Awards & highlights
Summary
This trial tests a cell therapy and radiotherapy for NHL. It will find out if it's safe and well-tolerated.
Who is the study for?
Adults over 18 with relapsed or refractory non-Hodgkin's lymphoma who've tried at least two systemic therapies can join this trial. They need to have a certain level of organ function, an accessible tumor for treatment, and not be pregnant. Participants must agree to use effective contraception and cannot have autoimmune diseases, recent other cancer treatments, uncontrolled illnesses, or active infections.
What is being tested?
The study is testing SIRPant-M cell therapy alone or combined with targeted radiotherapy in people with tough-to-treat non-Hodgkin's lymphoma. It aims to find out if these treatments are safe and how well patients tolerate them.
What are the potential side effects?
Potential side effects aren't specified here but generally could include typical reactions from cell therapies like fever, fatigue, immune system reactions; and from radiotherapy such as skin irritation at the treatment site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day -42 through day 364
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -42 through day 364
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs)
Secondary study objectives
Objective response rate (ORR)
Recommended phase 2 dose of autologous SIRPant-M +/- 2.5 Gy ×3 focal XRT
Trial Design
4Treatment groups
Experimental Treatment
Group I: SIRPant-M (90×10^6 cells) coupled with focal XRTExperimental Treatment2 Interventions
SIRPant-M coupled with 2.5 Gy of focal XRT administered within 24 hours after the first ITI and within 3 hours before to 24 hours after the second and third ITI
Group II: SIRPant-M (90×10^6 cells)Experimental Treatment1 Intervention
SIRPant-M Monotherapy
Group III: SIRPant-M (300×10^6 cells) coupled with focal XRTExperimental Treatment2 Interventions
SIRPant-M coupled with 2.5 Gy of focal XRT administered within 24 hours after the first ITI and within 3 hours before to 24 hours after the second and third ITI
Group IV: SIRPant-M (300×10^6 cells)Experimental Treatment1 Intervention
SIRPant-M Monotherapy
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Who is running the clinical trial?
SIRPant Immunotherapeutics, Inc.Lead Sponsor
Jelle Kijlstra, MD, MBAStudy DirectorSIRPant Immunotherapeutics
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stem cell transplant from a donor in the last 6 months.I do not have an active, uncontrolled hepatitis infection.I have a tumor or lymph node between 1.5 and 5 cm that can be easily accessed.My heart is functioning within normal limits.My blood pressure is under control.I have never had ITI therapy.I haven't had any cancer treatments in the last 14 days.I do not have a diagnosis of unclassifiable B cell lymphoma.I am not taking any blood-thinning medications that could risk bleeding during tumor injections.My kidney and liver are functioning well.I do not have lung problems that worsen with fluid buildup.I do not have any other cancer or serious illness that could affect the study.I don't take more than 10 mg/day of prednisone or its equivalent.I do not have an active, uncontrolled autoimmune disease.I have recovered from side effects of my cancer treatment, except for hair loss.I do not have active brain tumors or cancer spread to the brain.I am eligible for radiation therapy.I can take care of myself and am up and about more than 50% of my waking hours.I haven't had a live vaccine in the last 4 weeks.I do not have any ongoing infections.I am 18 or older and can agree to participate.My diagnosis of non-Hodgkin lymphoma is confirmed by lab tests.I haven't had stem cell or cellular therapy in the last month.I have not had IL-2 therapy in the last 6 months.My lymphoma has returned or didn't respond after 2 treatments, and I can't have other curative treatments.
Research Study Groups:
This trial has the following groups:- Group 1: SIRPant-M (300×10^6 cells) coupled with focal XRT
- Group 2: SIRPant-M (90×10^6 cells) coupled with focal XRT
- Group 3: SIRPant-M (90×10^6 cells)
- Group 4: SIRPant-M (300×10^6 cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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