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NCT04276870 · ClinicalTrials.gov registry record · Phase 2

Orphan Indications for CD19 Redirected Autologous T Cells

A Phase 2 study of Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL and Infants With Very High Risk KMT2A B-ALL, sponsored by Stephan Grupp MD PhD.

Recruiting
Registry status
Phase 2
Development phase
133
Enrollment target
1
Study location

NCT04276870: Recruiting Phase 2 study of Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL and Infants With Very High Risk KMT2A B-ALL, sponsored by Stephan Grupp MD PhD.

NCT04276870 is a Phase 2 study of Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL and Infants With Very High Risk KMT2A B-ALL that is actively recruiting participants, run by Stephan Grupp MD PhD. The registered enrollment target is 133 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04276870, a Phase 2 study of Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL and Infants With Very High Risk KMT2A B-ALL, is actively recruiting participants, sponsored by Stephan Grupp MD PhD.

RECRUITING
Registry status
Phase 2
Development phase
133 participants
Enrollment target
1
Study location

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).

Primary Outcome

1 year event-free survival (EFS), where events include no response, relapse, death due to any cause

Interventions

  • BIOLOGICAL Murine CART19

Study Locations (1)

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2020-03-12
Est. Completion 2037-03-10
Phase Phase 2
Stephan Grupp MD PhD

8 total trials

What NCT04276870 shows while recruiting

NCT04276870 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 3 conditions, with Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL appearing as the primary indexed condition, and to 1 intervention - of which Murine CART19 is the first listed.

NCT04276870 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04276870 about?

NCT04276870 is a clinical study titled "Orphan Indications for CD19 Redirected Autologous T Cells". 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 n...

What is the current status of trial NCT04276870?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2020-03-12. Estimated completion is 2037-03-10.

What conditions does trial NCT04276870 study?

This clinical trial studies the following 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.

What interventions are being tested in trial NCT04276870?

The interventions under investigation include: Murine CART19 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04276870?

This trial is sponsored by Stephan Grupp MD PhD, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04276870 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04276870's enrollment target sits among peer trials

133 538th of 2000 higher than 1,463 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04276870, the US trial registry maintained by the National Library of Medicine. NCT04276870 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.