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

• Status: Recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

1. Provision to sign and date the consent form.

2. Stated willingness to comply with all study procedures and be available for the duration of the study.

3. Males OR non-pregnant, non-lactating females

4. Aged 30 days to 25 years (inclusive) at time of consent and enrollment

5. Acute Lymphoid Leukemia OR Non-Hodgkins Lymphoma of B-cell origin that:

• Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both

• Has relapsed two or more times OR has relapsed at any time after allogeneic BMT OR is refractory to standard therapy as determined by the treating physician

6. Performance score of 50% or better

Exclusion Criteria:

1. Active CNS leukemia or lymphoma

2. Active Graft-versus-Host Disease (GvHD)

3. Active, uncontrolled, life threatening infection that at the determination of the treating physician would preclude safe apheresis 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 apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or cytokine release syndrome including:

• Myocardial dysfunction

• Baseline oxygen saturation of < 90% on room air

• Diffusion capacity of the lungs for carbon monoxide (DLCO) < 40%

• Transaminases > 10x upper limit of normal (ULN) or bilirubin >2x the ULN, unless thought to be related to leukemia/lymphoma infiltration

• 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, active Hepatitis B or Hepatitis C infection

7. Prior gene therapy

8. Current or prior therapies including:

• Monoclonal antibody therapy (i.e. blinatumomab) within 14 days of study enrollment

• Immunomodulatory drugs (i.e. tyrosine kinase inhibitors or calcineurin inhibitors) within 14 days of study enrollment

• Radiation therapy within 14 days of study enrollment

• Corticosteroid therapy in excess of maintenance dosing for adrenal insufficiency within 14 days of study enrollment

• Allogeneic blood or marrow transplant within 100 days of study enrollment

• Donor lymphocyte infusion or other cellular therapeutic within 30 days of study enrollment