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Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)

NCT05480449 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-12-26

No results posted yet for this study

Summary

This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).

Conditions

  • B Cell Acute Lymphoblastic Leukemia (B-ALL)
  • B Lineage Lymphoblastic Lymphoma

Interventions

BIOLOGICAL

Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19)

The investigational agent in this protocol is humanized CART19 cells (huCART19). Autologous T cells will be engineered to express an extracellular single chain antibody (scFv) with specificity for CD19. This will be expected to redirect specificity of the transduced T cells for cells that express CD19, a molecule that is restricted in expression on the surface of the malignant cells and on normal B cells.

Sponsors & Collaborators

Principal Investigators

  • Allison Barz Leahy, MD · Children's Hospital of Philadelphia

  • Stephan Grupp, MD,PhD · Children's Hospital of Philadelphia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
0 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2027-09-20
Completion
2029-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT05480449 on ClinicalTrials.gov