Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full Description

Pediatric patients with refractory or multiply relapsed leukemia and lymphoma do very poorly with traditional chemotherapy and have overall survival rates of well under 20%. There has been much excitement over the development of Car T cell therapy for these types of leukemia/lymphoma, but many patients may not fit the standard criteria to receive them or they cannot tolerate the extended wait and ongoing therapy that is needed for manufacture of these cells at the commercial level. With this study, the investigators will investigate a new CD19 directed CAR-T therapy that will be manufactured locally with a goal of wider patient inclusion and less delay to CAR-T infusion. The investigators hypothesize that CD19 directed CAR-T cells manufactured using the Prodigy ClinicMACS system developed by Miltenyi (UCD19 CAR-T) will be safe and tolerable and show preliminary efficacy in pediatric patients with relapsed and/or refractory B-ALL or B- NHL.

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Eligibility Criteria

Inclusion Criteria:

Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Males OR non-pregnant, non-lactating females
Aged 30 days to 25 years (inclusive) at time of consent and enrollment

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
Performance score of 50% or better

Exclusion Criteria:

Active CNS leukemia or lymphoma
Active Graft-versus-Host Disease (GvHD)
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

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 mLmin1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration
Known HIV infection, active Hepatitis B or Hepatitis C infection
Prior gene therapy

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04544592

Recruitment Status:

Recruiting

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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Children's Hospital Colorado
Aurora Colorado, 80045, United States More Info
Alison Sutton
Contact
720-777-9920
[email protected]
Amy Keating
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04544592

Recruitment Status:

Recruiting

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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