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NCT05098613 · ClinicalTrials.gov registry record · Phase 1
Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients
A Phase 1 study of Non-Hodgkin Lymphoma and Mantle Cell Lymphoma (MCL), sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT05098613: Recruiting Phase 1 study of Non-Hodgkin Lymphoma and Mantle Cell Lymphoma (MCL), sponsored by University of Colorado, Denver.
NCT05098613 is a Phase 1 study of Non-Hodgkin Lymphoma and Mantle Cell Lymphoma (MCL) that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 68 participants, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05098613, a Phase 1 study of Non-Hodgkin Lymphoma and Mantle Cell Lymphoma (MCL), is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.
Primary Outcome
Assessed by Type, Frequency, and Severity of Adverse Events (AEs). All AEs, including laboratory abnormalities, will be graded using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading criteria.
Conditions Studied
Interventions
- DRUG CD19x22 CAR T Cells
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT05098613 shows while recruiting
NCT05098613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (59% lower).
The record links to 4 conditions, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which CD19x22 CAR T Cells is the first listed.
NCT05098613 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05098613 about?
NCT05098613 is a clinical study titled "Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients". This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determin...
What is the current status of trial NCT05098613?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2021-12-21. Estimated completion is 2027-12.
What conditions does trial NCT05098613 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma, Mantle Cell Lymphoma (MCL), B-cell Non-Hodgkin Lymphoma (B-NHL), CNS Lymphoma.
What interventions are being tested in trial NCT05098613?
The interventions under investigation include: CD19x22 CAR T Cells (DRUG).
Who is sponsoring clinical trial NCT05098613?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05098613 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05098613's enrollment target sits among peer trials
68 48th of 106 higher than 59 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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