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NCT01475058 · ClinicalTrials.gov registry record · Phase 1

CD19 CAR T Cells for B Cell Malignancies After Allogeneic Transplant

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
1
Enrollment target

NCT01475058: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

NCT01475058 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01475058, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy.

Primary Outcome

Incidence of grade \>= 3 toxicity, as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 occurring from the T cell infusion through day 42 after the T cell infusion. Analysis will be performed separately in patients in complete remission (cohort A) or with detectable disease (cohort B) at day 28 post-transplant (prior to the T cell infusion). Incidence of acute GVHD occurring from the T cell infusion through day 42 after the T cell infus

Interventions

  • BIOLOGICAL allogeneic cytomegalovirus-specific cytotoxic T lymphocytes

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2012-04
Est. Completion 2014-07
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT01475058 record still lists

NCT01475058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which allogeneic cytomegalovirus-specific cytotoxic T lymphocytes is the first listed.

NCT01475058 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01475058 about?

NCT01475058 is a clinical study titled "CD19 CAR T Cells for B Cell Malignancies After Allogeneic Transplant". This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy.

What is the current status of trial NCT01475058?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2012-04. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01475058?

The interventions under investigation include: allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (BIOLOGICAL).

Who is sponsoring clinical trial NCT01475058?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01475058's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01475058, the US trial registry maintained by the National Library of Medicine. NCT01475058 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.