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Programmed Allogeneic CRISPR-edited T Cells Engineered to Express Anti-CD19 Chimeric Antigen Receptor (PACE CART19) in Patients With Relapsed Or Refractory CD19+ Leukemia and Lymphoma

NCT05037669 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-06-22

No results posted yet for this study

Summary

This is a Phase I trial to assess the safety and feasibility of administering pre-manufactured allogeneic T cells from healthy donors expressing CD19-targeting chimeric antigen receptors lacking expression of HLA class I, HLA class II molecules and endogenous TCR through CRISPR-mediated genome-editing of beta-2 microglobulin, CIITA and T cell receptor alpha chain, respectively. These cells are called PACE CART19 cells.

Conditions

Interventions

BIOLOGICAL

PACE CART19

PACE CART19 cells are allogeneic T cells transduced with a lentiviral vector to express an anti-CD19 scFv TCRz:41BB and electroporated to temporarily express the CRISPR/Cas9 RNA system resulting in beta-2 microglobulin (B2M), Class II Major Histocompatibility Complex Transactivator (CIITA) and TCR-α chain (TRAC) targeted disruption. PACE CART19 cells will be administered by IV infusion.

Sponsors & Collaborators

Principal Investigators

  • Noelle Frey, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2025-01-31
Completion
2038-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037669 on ClinicalTrials.gov