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Immunotherapy
NK Cells + IL-2 + Vactosertib for Cancer
Phase 1
Recruiting
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
Approved for 20 Other Conditions
No Placebo-Only Group
Summary
This trial tests a treatment for colorectal and certain blood cancers using special immune cells from healthy donors and two supportive drugs. It aims to boost the patient's immune system to better fight the cancer.
Who is the study for?
Adults over 18 with advanced colorectal cancer or blood cancers like leukemia, lymphoma, and myeloma who've tried at least one chemotherapy without success. They must be recovered from previous treatments, agree to use contraception, understand the study and consent to participate. Excluded are pregnant/breastfeeding women, those with untreated brain cancer involvement or certain infections (HIV/hepatitis), allergies to trial drugs, heart issues (QTcF ≥470 ms), on prohibited meds or needing immediate treatment.
What is being tested?
The trial is testing whether combining Natural Killer (NK) cells from healthy donors with two drugs—vactosertib and IL-2—is safe for treating colorectal and blood cancers. NK cells fight cancer but aren't FDA-approved; vactosertib is experimental too. IL-2 is approved for other cancers but used here in lower doses.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever and fatigue, possible organ inflammation due to NK cell activity against cancerous tissues, infusion-related reactions from drug administration, and typical chemotherapy side effects like nausea.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Secondary study objectives
Clinical Response
Persistence of donor NK cells
Awards & Highlights
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.
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
Vactosertib
Not yet FDA approved
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
Aldesleukin
FDA approved
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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
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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.
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