Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies
Public ClinicalTrials.gov record NCT06343376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Trial of CD19-Targeted Chimeric Antigen Receptor (CAR) Modified T Cells Genetically Engineered to Secrete Interleukin 12 (IL-12) and With a Truncated Human Epidermal Growth Factor Receptor (EGFRt) in Patients With Relapsed or Refractory CD19+ Hematologic Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Chimeric Antigen Receptor (CAR) T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies.
Study identification
- NCT ID
- NCT06343376
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 1 participant
Conditions and interventions
Conditions
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Follicular Lymphoma
- Recurrent High Grade B-Cell Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Transformed Chronic Lymphocytic Leukemia
- Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Diffuse Large B-Cell Lymphoma
- Refractory Follicular Lymphoma
- Refractory High Grade B-Cell Lymphoma
- Refractory Mantle Cell Lymphoma
- Refractory Transformed Chronic Lymphocytic Leukemia
- Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions
- Biopsy Procedure
- Biospecimen Collection Procedure
- Bone Marrow Aspiration Procedure
- Bone Marrow Biopsy Procedure
- Computed Tomography Procedure
- Cyclophosphamide Drug
- Echocardiography Procedure
- EGFRt/19-28z/IL-12 CAR T-lymphocytes Biological
- Fludarabine Phosphate Drug
- Leukapheresis Procedure
- Multigated Acquisition Scan Procedure
- Positron Emission Tomography Procedure
Procedure · Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2024
- Primary completion
- Jan 2, 2025
- Completion
- Jan 2, 2025
- Last update posted
- Aug 2, 2025
2024 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06343376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06343376 live on ClinicalTrials.gov.