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Immunotherapy
NK Cells + IL-2 + Vactosertib for Cancer
Phase 1
Waitlist Available
Led By Jennifer Eva Selfridge, MD PhD
Research Sponsored by Jennifer Eva Selfridge
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 28 days post-treatment
Awards & highlights
Study Summary
This trial is testing a new way to treat cancer by using NK cells from a healthy donor and two medicines, vactosertib and IL-2. Vactosertib and NK cells are experimental, and IL-2 is being used at a lower dose than what is approved.
Eligible Conditions
- Chronic Lymphocytic Leukemia
- Myeloproliferative Syndrome
- Myelodysplastic Syndrome
- Non-Hodgkin's Lymphoma
- Hodgkin's Lymphoma
- Multiple Myeloma
- Colorectal Cancer
- Blood Cancers
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days post-treatment
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 [Safety and Tolerability])
Secondary outcome measures
Clinical Response
Persistence of donor NK cells
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental InfusionExperimental Treatment5 Interventions
Preparative Regimen Administration:
Fludarabine will be given at a dose of 30mg/m2 intravenously daily
Cyclophosphamide will be given at a dose of 500mg/m2 intravenously daily
Investigational Agent Administration:
NK Cell Product will be given per institutional standard of care (at a rate no faster than 250mL per hour or 3-4 ml per minute) as two doses by intravenous infusion on Days 0 (+2 days acceptable) and 14 (+/- 3 days acceptable)
IL-2 will be administered at a flat dose of 2.2 million IU subcutaneously starting on the same day as the first NK cell infusion and will be administered three times weekly (dose level 1) or twice weekly (dose level -1) for up to four weeks total
Vactosertib will be administered at a dose of 200mg twice daily for 5 consecutive days per week, for up to four weeks total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Aldesleukin
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
Jennifer Eva SelfridgeLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Jennifer Eva Selfridge, MD PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have untreated cancer in your brain or spinal cord.You have had allergic reactions to fludarabine or cyclophosphamide in the past.You have HIV and are taking medication for it.You have ongoing, untreated hepatitis B or C infection.Your heart's electrical activity, measured from a heart test, is longer than it should be.You are currently taking medications that are not allowed while using vactosertib.If waiting 29 days for treatment could impact other treatment options for you, you cannot participate.You have had a transplant from another person and have a skin rash that covers more than 10% of your body, caused by a reaction from the transplant.You have been diagnosed with advanced colorectal cancer or a type of blood cancer that has not responded to standard chemotherapy.You can join the study if you said no to the usual treatments, or if there's no standard treatment for your specific type of cancer according to NCCN guidelines.You are taking more than 10mg of prednisone or a similar steroid.You have a performance status score of 2 or lower according to the Eastern Cooperative Oncology Group.You must have normal functioning organs and bone marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Infusion
Awards:
This trial has 2 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
Is there a current opportunity for participants to enroll in this trial?
"Affirmative. Clinicaltrials.gov contains information about this clinical trial, which was published on September 9th 2022 and recently modified on November 29th 2022. 12 individuals are being sought from a single medical centre for the experiment."
Answered by AI
What potential harm can be caused by Natural Killer Cells?
"Clinical evidence of Natural Killer Cells' safety and efficacy is limited, putting it at a score of 1 on the Power team's scale."
Answered by AI
What is the scope of individuals being enrolled in this clinical trial?
"Affirmative. According to the clinicaltrials.gov data, this medical experiment is open for applications and was posted on September 9th 2022 with its last edit occuring on November 29th of that same year. The study requires 12 participants from a single location."
Answered by AI
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