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NCT03050216 · ClinicalTrials.gov registry record · Phase 2

QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML

A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
Phase 2
Development phase
8
Enrollment target

NCT03050216: Completed Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT03050216 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03050216, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
8 participants
Enrollment target

Study Summary

This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted, ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute myelogenous leukemia (AML).

Primary Outcome

To estimate the rate of complete remission with incomplete platelet recovery (CRp) - defined as leukemic clearance and neutrophil recovery without platelet recovery - by day 42 after the infusion of CD3/CD19 depleted, ALT-803 stimulated, donor NK cells and subcutaneous ALT-803 given after a non-myeloablative preparative regimen for the treatment of refractory or released acute myelogenous leukemia (AML)

Interventions

  • BIOLOGICAL ALT-803

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2017-05-16
Est. Completion 2019-12-15
Phase Phase 2

What the finished NCT03050216 record still lists

NCT03050216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which ALT-803 is the first listed.

NCT03050216 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03050216 about?

NCT03050216 is a clinical study titled "QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML". This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted, ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute myelogenous leukemia (AML).

What is the current status of trial NCT03050216?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2017-05-16. Estimated completion is 2019-12-15.

What interventions are being tested in trial NCT03050216?

The interventions under investigation include: ALT-803 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03050216?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03050216's enrollment target sits among peer trials

8 1990th of 2000 higher than 5 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 NCT03050216, the US trial registry maintained by the National Library of Medicine. NCT03050216 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.