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NCT04119024 · ClinicalTrials.gov registry record · Phase 1

Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors

A Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by Anusha Kalbasi.

Recruiting
Registry status
Phase 1
Development phase
18
Enrollment target
3
Study locations

NCT04119024 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma that is actively recruiting participants, run by Anusha Kalbasi. The registered enrollment target is 18 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT04119024, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, is actively recruiting participants, sponsored by Anusha Kalbasi.

RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
3
Study locations

Study Summary

This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study agent is called IL13Ralpha2 CAR T cells. T cells are a special type of white blood cell (immune cells) that have the ability to kill tumor cells. The T cells are obtained from the patient's own blood, grown in a laboratory, and modified by adding the IL13Ralpha2 CAR gene. The IL13Ralpha2 CAR gene is inserted into T cells with a virus called a lentivirus. The lentivirus allows cells to make the IL13Ralpha2 CAR protein. This CAR has been designed to bind to a protein on the surface of tumor cells called IL13Ralpha2. This study is being done to determine the dose at which the gene-modified immune cells are safe, how long the cells stay in the body, and if the cells are able to attack the cancer.

Conditions Studied

Metastatic Malignant Solid Neoplasm Metastatic Melanoma Refractory Malignant Solid Neoplasm Neuroendocrine Tumors Recurrent Malignant Solid Neoplasm Uveal Melanoma Paraganglioma Pathologic Stage IV Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Acral Melanoma

Interventions

  • DRUG Cyclophosphamide
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • DRUG Fludarabine Phosphate

Study Locations (3)

California

  • City of Hope - Duarte
  • UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
  • Stanford Cancer Institute - Stanford

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2025-10-07
Est. Completion 2026-10
Phase Phase 1

Sponsor

Anusha Kalbasi

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04119024

The ClinicalTrials.gov registry entry for NCT04119024 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (91% lower). The listed sponsor is Anusha Kalbasi, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT04119024 reports 3 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04119024 about?

NCT04119024 is a clinical study titled "Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors". This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study age...

What is the current status of trial NCT04119024?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-10-07. Estimated completion is 2026-10.

What conditions does trial NCT04119024 study?

This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Refractory Malignant Solid Neoplasm, Neuroendocrine Tumors, Recurrent Malignant Solid Neoplasm.

What interventions are being tested in trial NCT04119024?

The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Fludarabine Phosphate (DRUG).

Who is sponsoring clinical trial NCT04119024?

This trial is sponsored by Anusha Kalbasi, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04119024 being conducted?

This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.