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

> **NCT04119024** · PHASE1 · RECRUITING · sponsor: **Anusha Kalbasi** · enrollment: 18 (estimated)

## Conditions studied

- Metastatic Malignant Solid Neoplasm
- Metastatic Melanoma
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Recurrent Malignant Solid Neoplasm
- Refractory Malignant Solid Neoplasm
- Uveal Melanoma
- Acral Melanoma
- Neuroendocrine Tumors
- Paraganglioma
- Pheochromocytoma
- Adrenocortical Carcinoma
- Pancreatic Neuroendocrine Tumor
- Thyroid Cancer
- Breast Cancer
- Lung Adenocarcinoma
- Head and Neck Squamous Cell Carcinoma

## Interventions

- **PROCEDURE:** Biopsy
- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Computed Tomography
- **DRUG:** Cyclophosphamide
- **DRUG:** Fludarabine Phosphate
- **OTHER:** Fludeoxyglucose F-18
- **BIOLOGICAL:** IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells
- **PROCEDURE:** Magnetic Resonance Imaging
- **PROCEDURE:** Positron Emission Tomography

## Key facts

- **NCT ID:** NCT04119024
- **Lead sponsor:** Anusha Kalbasi
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-10-07
- **Primary completion:** 2026-10
- **Final completion:** 2026-10
- **Target enrollment:** 18 (ESTIMATED)
- **Last updated:** 2026-03-17

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04119024

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04119024, "Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04119024. Licensed CC0.

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