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CAR T-cell Therapy
UCD19 CAR T Cells for B-Cell Lymphoma
Phase 1
Waitlist Available
Led By Manali Kamdar, MD
Research Sponsored by University of Colorado, Denver
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 1 year post-infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether it is possible to modify a person's own immune cells to kill B-cell NHL that has relapsed or is refractory to chemotherapy, and whether it is possible to do this without severe side effects.
Who is the study for?
Adults aged 18-80 with B-cell non-Hodgkin lymphoma that's come back or didn't respond to treatment may join. They must have no other cure options, be in fairly good health, and not planning pregnancy for a year post-treatment. Excluded are those with recent monoclonal antibody therapy, severe psychiatric issues, certain lung/infection conditions, prior gene/CAR T cell therapy, HIV/Hepatitis B/C infection.
What is being tested?
The trial is testing UCD19 CAR T Cells on adults with relapsed/refractory B-NHL. Participants' own T cells will be modified in the lab to fight cancer by adding a new gene through a weakened virus and then returned to their body via IV injection.
What are the potential side effects?
Potential side effects include immune reactions due to modified T cells attacking normal cells (cytokine release syndrome), infusion-related reactions like fever or chills, increased risk of infections due to immune system modification.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility: Percent of Participants successfully infused with UCD19 CAR T Cells
Feasibility: Successful manufacture of UCD19 CAR T Cells, as determined by the number of successfully manufactured doses
Safety: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) within 30 days after treatment
+1 moreSecondary study objectives
Efficacy: Overall Survival (OS) at 1 Year
Heart rate
Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 6 Months
+2 moreAwards & Highlights
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: UCD19 CAR T CellsExperimental Treatment1 Intervention
Participants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector \[LV\] Transduced Autologous Peripheral Blood Lymphocytes
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,802 Previous Clinical Trials
2,822,101 Total Patients Enrolled
Manali Kamdar, MDPrincipal InvestigatorUniversity of Colorado Denver, Anschutz Medical Campus
2 Previous Clinical Trials
24 Total Patients Enrolled
Michael Verneris, MDStudy DirectorUniversity of Colorado Denver, Anschutz Medical Campus
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a type of medication called monoclonal antibody therapy within the past 14 days.There are no other treatments that can cure your condition, as decided by your main doctor.You do not currently have Graft-versus-Host Disease (GvHD).The doctor thinks that cellular therapy is not a good option for you, for any reason.You have received any type of gene therapy or CAR T cell therapy in the past.You have a current, ongoing condition affecting your brain or spinal cord.You have received a stem cell transplant from another person within the past 90 days and have been on immunosuppressive therapy for at least 4 weeks.You have tried and didn't benefit from at least two different types of treatment.You are not eligible if you cannot receive a type of treatment called CD19 CAR T Cells, which is available to the public.
Research Study Groups:
This trial has the following groups:- Group 1: UCD19 CAR T Cells
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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