Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Participants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector \[LV\] Transduced Autologous Peripheral Blood Lymphocytes

Lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector \[LV\] Transduced Autologous Peripheral Blood Lymphocytes)

UCD19 CAR T Cells

Michael Verneris, MD

Manali Kamdar, MD

This study will test whether immune cells modified to recognize B-cell non-Hodgkin lymphoma (NHL) can be successfully manufactured at the University of Colorado Anschutz and whether these cells can be administered with an acceptable safety profile. Adults who have been diagnosed with B-cell non-Hodgkin lymphoma (NHL) that has relapsed or no longer responds to chemotherapy (relapsed or refractory) may be eligible to participate in this study.

The investigators will use participants own immune cells, called T cells, to kill the lymphoma. These T cells are involved in fighting infections and in some cases, can also kill cancer cells. The investigators will extract T cells from the participant's blood, modify the cells in a laboratory, and then return teh cells to the participant's body via intravenous (IV) injection. In the laboratory, the investigators will add a new gene into the T cells that allows the T cells to recognize and kill the lymphoma cells, and allows these modified cells to multiply and increase in numbers. To put the new gene into your T cells, the investigators will use a weakened virus. The virus is modified so that it cannot multiply or spread once the cells are infused.

The objective of this Phase 1 open-label study is to assess the feasibility of UCD19 Chimeric Antigen Receptor (CAR) T Cells manufacture onsite, successful infusion of eligible subjects, and safety of UCD19 CAR T Cells infusion in subjects with relapsed/refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL).

Six (6) subjects will participate in the initial cohort of this open-label, single arm, single site study to assess dose-limiting toxicity (DLT) and safety; the first set of 3 subjects will initiate treatment with lymphodepleting chemotherapy prior to CAR T cell infusion staggered 30 days from CAR T cell dosing of the previously treated subject. Depending on the assessment of DLTs, the second set of 3 subjects may be enrolled and dosed without stagger.

After the initial 6 subjects have received treatment, an additional 14 subjects will participate in the Phase 1 expansion study.

Participants will include adults with relapsed/ primary refractory CD19 positive (i.e. CD19 expressing) B-NHL as confirmed by either flow cytometry, immunohistochemistry (IHC), or both who are not candidates for other curative forms of therapy. Enrolled participants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector \[LV\] Transduced Autologous Peripheral Blood Lymphocytes). Participants will be enrolled up to 1 month before anticipated date of apheresis, and will be considered completed at 12 months post-treatment.

Long Term Follow Up will be conducted under a separate protocol and will occur for up to 15 Years to collect data on the long-term safety of UCD19 CAR T Cells, and for the observation, detection, and evaluation of latent adverse reactions including secondary malignancies.

While this study focuses on primary endpoints for feasibility of the manufacturing and infusion processes and safety of the administered UCD19 CAR T Cells, preliminary evidence of effectiveness will be collected and analyzed for use in planning future CAR T cell therapy studies.

Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)

Phase I Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)

The successful manufacture of UCD19 Chimeric Antigen Receptor (CAR) T Cells onsite meeting the IND-defined release criteria. Manufacture of UCD19 CAR T Cells will begin after enrollment and be completed within 1 month. Success will be determined by whether or not the participant's CAR T Cell count meets the target dose required for infusion at Day 0. The number of successfully manufactured doses will be reported.

The percent of participants who are able to receive an infusion of UCD19 CAR T cells.

The number of subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).

The percent of all subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).

The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 90 days post-treatment, as determined by the investigators.

The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 6 months post-treatment, as determined by the investigators.

The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 1 Year post-treatment, as determined by the investigators.

Number of participants with Progression Free Survival (PFS) at 1 year post-infusion.

Number of participants surviving at 1 year post-infusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)	NCT04240808	Non Hodgkin Lym...	UCD19 CAR T Cel...	18 Years - 80 Years	University of Colorado, Denver
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)	NCT04240808	Non Hodgkin Lym...	UCD19 CAR T Cel...	18 Years - 80 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for ucd19 car t cells