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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

Study 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.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
Efficacy: Median Duration of Remission at 1 Year
Efficacy: Overall Survival (OS) at 1 Year
Heart rate
+5 more

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,736 Previous Clinical Trials
2,149,184 Total Patients Enrolled
Michael Verneris, MDStudy DirectorUniversity of Colorado Denver, Anschutz Medical Campus
Manali Kamdar, MDPrincipal InvestigatorUniversity of Colorado Denver, Anschutz Medical Campus
2 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

UCD19 CAR T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04240808 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: UCD19 CAR T Cells
UCD19 CAR T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04240808 — Phase 1
Non-Hodgkin's Lymphoma Clinical Trial 2023: UCD19 CAR T Cells Highlights & Side Effects. Trial Name: NCT04240808 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what population is this research opportunity available?

"This medical research is searching for 11 volunteers who suffer from lymphoma and fall within the 18 to 80 year old age bracket. In addition, potential participants must fulfill certain requirements such as: Willingly agree to all procedures of the study, Have experienced failures with two or more systemic treatments, Be male or non-pregnant/non-lactating female adults between 18-80 years old., Achieve a performance status according to the Eastern Cooperative Oncology Group no higher than 2, Not be eligible to receive commercially available CD19 CAR T Cells., And have an intermediate form of lymphoma that falls somewhere between Burkitt and DLBC"

Answered by AI

How hazardous is the deployment of UCD19 CAR T Cells for humans?

"The relative safety of UCD19 CAR T Cells is rated as a 1 on the scale due to this being an early-stage trial with only small amounts of data available regarding efficacy and general safety."

Answered by AI

Is this research recruiting participants right now?

"The clinical trial listed on clinicaltrials.gov is no longer accepting patients, despite its initial posting date of July 17th 2020 and most recent update from September 1st 2022. Nevertheless, there are currently 1,796 other studies that require participants."

Answered by AI

Are those over 35 years of age eligible for participation in this trial?

"This clinical trial has designated the age range of 18-80 as its eligibility criteria for participants."

Answered by AI
~2 spots leftby Apr 2025