UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age31-30
SponsorUniversity of Colorado, Denver
About this trial
This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.
Eligibility criteria
Qualifiers
Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.
Provision of signed and dated consent form from parent or guardian (patients <18), the patient themselves (>18), or legally authorized representative (patient >18 who lack decision-making capacity); Pediatric patients will be included in age-appropriate discussions and assent will be obtained for those > 7 years of age, when appropriate, according to institutional standards.
Willingness to participate in long term follow up study.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Disqualifiers
Evidence of rapidly progressive disease without adequate salvage/bridging regimens as determined by the investigator.
Active Graft-versus-Host Disease (GvHD).
Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of LD chemotherapy, cell infusion, or cytokine release syndrome.
Myocardial dysfunction: Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG) findings.
Trial design
Treatments tested in this trial
- CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
Children's Hospital Colorado
Collaborator
Source ClinicalTrials.gov