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Orphan Indications for CD19 Redirected Autologous T Cells

NCT04276870 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2026-03-06

No results posted yet for this study

Summary

This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D).

Conditions

  • Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL
  • Infants With Very High Risk KMT2A B-ALL
  • Patients With Central Nervous System Relapse Who Did Not Receive Cranial Radiation or Bone Marrow Transplantation

Interventions

BIOLOGICAL

Murine CART19

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection with a planned dose of 5x106 CART19 cells/kg on day 0 with possible reinfusion/retreatment

Sponsors & Collaborators

Principal Investigators

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

  • Amanda DiNofia, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2028-03-10
Completion
2037-03-10
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 NCT04276870 on ClinicalTrials.gov