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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs)
Secondary outcome measures
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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction SIRPant-M (90×10^6 cells) for medical use?
"The assessment of the safety profile for SIRPant-M (90×10^6 cells) was rated a 1 due to its status as an early stage clinical trial, where both efficacy and safety data is scarce."
Answered by AI
Is enrollment for this clinical experiment open at the moment?
"Clinicaltrials.gov affirms that this particular clinical trial, initially published on December 1st 2023 and last amended on July 21st 2023 is not currently looking for participants. However, 1727 other studies have started recruiting patients recently."
Answered by AI
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