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CAR T-cell Therapy
Stem Cell + CAR T-Cell Therapy for Blood Cancers
Phase 1
Recruiting
Research Sponsored by Joshua Sasine, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or refractory disease, defined by disease progression after last regimen, or refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen
Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 0 to day 60.
Awards & highlights
Study Summary
This trial studies combining stem cells from the patient's body with CAR T-cell therapy to treat relapsed/refractory hematologic diseases. It will assess safety and feasibility of collecting stem cells and evaluate response to treatment.
Who is the study for?
Adults aged 18-85 with certain blood cancers that have come back or haven't responded to treatment can join. They must be healthy enough for the procedure, not have had recent heart issues or transplants, and can't be pregnant or breastfeeding. Participants need to agree to birth control use and follow study procedures.Check my eligibility
What is being tested?
The trial is testing if it's possible and safe to collect a person's own stem cells and add them to CAR T-cell therapy in patients whose blood cancer has returned after treatment or hasn’t improved. It will track how well this works in 20 people over the first two months by looking at side effects like CRS and ICANS.See study design
What are the potential side effects?
Possible side effects include cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat; immune effector cell-associated neurotoxicity syndrome (ICANS), which may lead to confusion, difficulty speaking or understanding speech; as well as other common adverse events from treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened after the last treatment or didn't improve significantly.
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I do not have any ongoing infections.
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My blood cancer is recognized by WHO and treatable with approved CAR T therapy.
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I am between 18 and 85 years old.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 0 to day 60.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 0 to day 60.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess feasibility of collecting the target HSC cell dose for at least 50% of enrolled patients.
To assess safety of aHSC to planned CAR T therapy in the first 60 days through the incidence, severity, and duration of CRS based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system.
To assess safety of aHSC to planned CAR T therapy in the first 60 days through the incidence, severity, and duration of ICANS based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system.
Secondary outcome measures
Assess platelet count and transfusion independence rate by Day 28.
Assess rate of recovery of absolute neutrophil count (ANC) by Day 28.
Assess red blood cell (RBC) count and transfusion independence by Day 28.
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CAR T Therapy with Autologous Hematopoietic Stem Cells (aHSCs)Experimental Treatment1 Intervention
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Who is running the clinical trial?
Joshua Sasine, MD, PhDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have or might have an infection that isn't under control or needs IV drugs.I have not received a live vaccine in the last 6 weeks.Women who can have children must take a pregnancy test before the study starts.My condition worsened after the last treatment or didn't improve significantly.I agree to use birth control during and for 6 months after the trial, unless I am not of childbearing potential due to surgery or menopause.It's been over 2 weeks or 5 half-lives since my last cancer treatment.I do not have abnormal blood cell growth detected in my bone marrow.I do not have any ongoing infections.My side effects from previous treatments are mild or gone, except for hair loss.I haven't taken high doses of steroids or immunosuppressants recently.My blood cancer is recognized by WHO and treatable with approved CAR T therapy.I am planning to or have had a stem cell transplant within 8 weeks before CAR T therapy.I had a cell transplant from a donor within the last 8 weeks.I haven't had a heart attack or other major heart issues in the last 6 months.I have a history of seizures, stroke, dementia, or autoimmune disease affecting my brain.I am between 18 and 85 years old.I am able to care for myself and perform daily activities.My blood, liver, and heart are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: CAR T Therapy with Autologous Hematopoietic Stem Cells (aHSCs)
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.
Is this research comprised of participants who are more than forty years old?
"Eligibility for this clinical trial is contingent upon patients being between 18 and 85 years of age."
Answered by AI
Am I eligible to take part in this particular medical experiment?
"Eligibility criteria for this trial include having multiple myeloma and being between the ages of 18-85. Approximately 20 patients are expected to be accepted into the study."
Answered by AI
Has the FDA sanctioned CAR T Therapy using Autologous Hematopoietic Stem Cells (aHSCs)?
"As this is a Phase 1 trial, and the available data on safety and effectiveness are limited, our team at Power has assigned CAR T Therapy with Autologous Hematopoietic Stem Cells (aHSCs) a score of 1."
Answered by AI
Are there any openings still available to join this clinical research protocol?
"According to clinicaltrials.gov, this medical experimentation is not currently recruiting subjects for participation. This trial was initially posted on August 15th 2023 and last updated on May 31st 2023. Currently, there are over 5000 other trials that are actively accepting participants though."
Answered by AI
What is the targeted outcome of this research experiment?
"This trial will track safety parameters from Day 0 to Day 10 and the primary objective is to assess CRS incidence, severity, and duration in accordance with ASTCT criteria within 60 days. Secondary objectives involve monitoring ANC recovery by day 28, RBC count transfusion independence rates by day 28, and platelet count transfusion independency rates likewise on day 28."
Answered by AI
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