UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04544592|
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : August 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia B-cell Non Hodgkin Lymphoma||Drug: CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||February 24, 2021|
|Estimated Primary Completion Date :||June 2026|
|Estimated Study Completion Date :||July 2026|
Experimental: UCD19 CART infusion
Lymphodepleting chemotherapy following by infusion of UCD19 CAR-T
Drug: CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells
The CD19 CAR used in this study consists of three main components: the variable regions of the anti-CD19 monoclonal antibody FMC63 71, linked to the TNFRSF19-derived transmembrane domain, the 4-1BB costimulatory molecule, and the signaling domain of the CD3-zeta molecule. The DNA encoding this receptor was cloned into a lentiviral vector (LV) backbone.
- Dose limiting toxicities [ Time Frame: Up to 21 months ]Adverse events (toxicity assessments) will be done by medical staff at different time points
- Overall Survival [ Time Frame: 5 years ]The subject will be followed throughout the study and up to 5 years after the study for overall survival.
- Time to Transplant [ Time Frame: 5 years ]The subject will be followed throughout the study and up to 5 years after the study for time to transplant.
- Relapse [ Time Frame: 5 years ]The subject will be followed throughout the study and up to 15 years after the study for relapse.
- Non-Relapse Mortality [ Time Frame: 5 years ]The subject will be followed throughout the study and up to 15 years after the study for non-relapse mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544592
|Contact: Amy Keating, MDemail@example.com|
|Contact: Cheri Adams||Cheri.Adams@childrenscolorado.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Courtney Newbold 720-848-0653 firstname.lastname@example.org|
|Principal Investigator: Amy Keating|
|Principal Investigator:||Amy Keating, MD||Children's Hospital Colorado|