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NCT04020575 · ClinicalTrials.gov registry record · Phase 1
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
A Phase 1 study of Metastatic Breast Cancer, sponsored by Minerva Biotechnologies Corporation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT04020575: Recruiting Phase 1 study of Metastatic Breast Cancer, sponsored by Minerva Biotechnologies Corporation.
NCT04020575 is a Phase 1 study of Metastatic Breast Cancer that is actively recruiting participants, run by Minerva Biotechnologies Corporation. The registered enrollment target is 69 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04020575, a Phase 1 study of Metastatic Breast Cancer, is actively recruiting participants, sponsored by Minerva Biotechnologies Corporation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase I/II study of adoptive immunotherapy for advanced MUC1\* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1\*).
Primary Outcome
To determine the safety and maximally tolerated cell dose (MTD) and recommended phase 2 cell dose (RP2D) of ex vivo expanded autologous huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells for patients with advanced MUC1\* positive breast cancer using CTCAE version 5.0 and Lee criteria.
Conditions Studied
Interventions
- BIOLOGICAL huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells
- BIOLOGICAL huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2035-01-15 |
| Phase | Phase 1 |
What NCT04020575 shows while recruiting
NCT04020575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells is the first listed.
NCT04020575 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04020575 about?
NCT04020575 is a clinical study titled "Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)". Phase I/II study of adoptive immunotherapy for advanced MUC1\* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1\*).
What is the current status of trial NCT04020575?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2020-01-15. Estimated completion is 2035-01-15.
What conditions does trial NCT04020575 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT04020575?
The interventions under investigation include: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells (BIOLOGICAL), huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D (BIOLOGICAL).
Who is sponsoring clinical trial NCT04020575?
This trial is sponsored by Minerva Biotechnologies Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04020575 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04020575's enrollment target sits among peer trials
69 71st of 139 higher than 69 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer 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.
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