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NCT04991870 · ClinicalTrials.gov registry record · Phase 1
Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM
A Phase 1 study of Recurrent Gliosarcoma and Recurrent Supratentorial Glioblastoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04991870: Recruiting Phase 1 study of Recurrent Gliosarcoma and Recurrent Supratentorial Glioblastoma, sponsored by M.D. Anderson Cancer Center.
NCT04991870 is a Phase 1 study of Recurrent Gliosarcoma and Recurrent Supratentorial Glioblastoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 33-participant average among 7 other Recurrent Gliosarcoma trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04991870, a Phase 1 study of Recurrent Gliosarcoma and Recurrent Supratentorial Glioblastoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is to find out the best dose, possible benefits and/or side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \[CB\]-NK-TGF-betaR2-/NR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-/NR3C1- cells are genetically changed immune cells that may help to control the disease.
Primary Outcome
Will determine maximum tolerated dose and safety of escalating doses of cord blood (CB)-(NK) cells patients with recurrent glioblastoma. A DLT is defined as any grade \>= 3 adverse event assessed as related to CB-NK cells by the investigator (that is, grade \>= 3 adverse drug reaction; grading according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03.
Conditions Studied
Interventions
- PROCEDURE Resection
- BIOLOGICAL Cord Blood-derived Expanded Allogeneic Natural Killer Cells
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-04-28 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
What NCT04991870 shows while recruiting
NCT04991870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 33-participant average among 7 other Recurrent Gliosarcoma trials with a reported enrollment target (24% lower).
The record links to 3 conditions, with Recurrent Gliosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Resection is the first listed.
NCT04991870 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04991870 about?
NCT04991870 is a clinical study titled "Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM". This phase I trial is to find out the best dose, possible benefits and/or side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \[CB\]-NK-TGF-betaR2-/NR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-/NR...
What is the current status of trial NCT04991870?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-04-28. Estimated completion is 2027-01-31.
What conditions does trial NCT04991870 study?
This clinical trial studies the following conditions: Recurrent Gliosarcoma, Recurrent Supratentorial Glioblastoma, Supratentorial Gliosarcoma.
What interventions are being tested in trial NCT04991870?
The interventions under investigation include: Resection (PROCEDURE), Cord Blood-derived Expanded Allogeneic Natural Killer Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04991870?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04991870 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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