RECRUITING

UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL

Conditions

B-cell Acute Lymphoblastic Leukemia B-cell Non Hodgkin Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1/2 Dose Escalation and Preliminary Efficacy of CD19 Directed Car T Cells Generated Using the Miltenyi Clinimacs Prodigy System (UCD19 CarT) in Pediatric Patients with Relapsed And/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL) and B-Cell Non-Hodgkins Lymphoma(B-NHL)

Quick Facts

Study Start:2021-02-24

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04544592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:31 Days to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines; 2. 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); 3. Willingness to participate in long-term follow-up study; 4. Stated willingness to comply with all study procedures and be available for the duration of the study; 5. Males OR non-pregnant, non-lactating females; 6. Aged 31 days to 30 years (inclusive) at time of consent and enrollment; 7. Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that: * Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both ; * Meets any one of the following conditions: * Non-Hodgkin Lymphoma includes all of the following: 8. Performance score (Lansky or Karnofsky) of 50% or better; 9. Unable to receive commercially available CD19 CAR-T Therapy.	1. Active, uncontrolled CNS leukemia or lymphoma, as clinically indicated, at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre-cell infusion; 2. Active Graft-versus-Host Disease (GvHD); 3. Active, uncontrolled, life threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or cytokine release syndrome; 4. Evidence of severe organ dysfunction that at the determination of the treating physician would preclude safe leukapheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or cytokine release syndrome including any of the following: * Myocardial dysfunction (based on age standards) * Baseline oxygen saturation of \< 90% on room air * Diffusion capacity of the lungs for carbon monoxide (DLCO) \< 40%, as determined within 45 days before cell infusion * Transaminases \> 10x upper limit of normal (ULN) or bilirubin \>2x the ULN, unless thought to be related to primary disease * Estimated Cr clearance \<60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance) 5. Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration; 6. Known HIV infection, or active Hepatitis B or active Hepatitis C infection; 7. Prior gene therapy, including prior CAR-T cell.

Inclusion Criteria

Exclusion Criteria

1. Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines;
2. 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);
3. Willingness to participate in long-term follow-up study;
4. Stated willingness to comply with all study procedures and be available for the duration of the study;
5. Males OR non-pregnant, non-lactating females;
6. Aged 31 days to 30 years (inclusive) at time of consent and enrollment;
7. Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:
* Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both ;
* Meets any one of the following conditions:
* Non-Hodgkin Lymphoma includes all of the following:
8. Performance score (Lansky or Karnofsky) of 50% or better;
9. Unable to receive commercially available CD19 CAR-T Therapy.

1. Active, uncontrolled CNS leukemia or lymphoma, as clinically indicated, at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre-cell infusion;
2. Active Graft-versus-Host Disease (GvHD);
3. Active, uncontrolled, life threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or cytokine release syndrome;
4. Evidence of severe organ dysfunction that at the determination of the treating physician would preclude safe leukapheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or cytokine release syndrome including any of the following:
* Myocardial dysfunction (based on age standards)
* Baseline oxygen saturation of \< 90% on room air
* Diffusion capacity of the lungs for carbon monoxide (DLCO) \< 40%, as determined within 45 days before cell infusion
* Transaminases \> 10x upper limit of normal (ULN) or bilirubin \>2x the ULN, unless thought to be related to primary disease
* Estimated Cr clearance \<60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
5. Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration;
6. Known HIV infection, or active Hepatitis B or active Hepatitis C infection;
7. Prior gene therapy, including prior CAR-T cell.

Contacts and Locations

Study Contact

Vanessa Fabrizio, MD, MS

CONTACT

720-777-6860

BMT@childrenscolorado.org

Kayla Ortiz

CONTACT

720-777-2564

kayla.ortiz@childrenscolorado.org

Principal Investigator

Vanessa Fabrizio, MD, MS

PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Study Locations (Sites)

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Vanessa Fabrizio, MD, MS, PRINCIPAL_INVESTIGATOR, Children's Hospital Colorado

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-24

Study Completion Date2026-07

Study Record Updates

Study Start Date2021-02-24

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

B-cell Acute Lymphoblastic Leukemia
B-cell Non Hodgkin Lymphoma