huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
Public ClinicalTrials.gov record NCT03103971. 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 Two-Stage Phase 1 Open-Label Study of huJCAR014, CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells Bearing a Human Binding Domain, in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Acute Lymphocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial studies the side effects of huJCAR014 in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their surfaces. In Stage 1, dose-finding studies will be conducted in 3 cohorts: 1. Aggressive B cell NHL 2. Low burden ALL 3. High burden ALL In Stage 2, studies may be conducted in one or more cohorts to collect further safety, PK, and efficacy information at the huJCAR014 dose level(s) selected in Stage 1 for the applicable cohort(s). There are two separate cohorts for stage 2: 1. Cohort 2A, CAR-naïve (n=10): patients who have never received CD19 CAR-T cell therapy. 2. Cohort 2B, CAR-exposed (n=27): patients who have previously failed CD19 CAR-T cell therapy.
Study identification
- NCT ID
- NCT03103971
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 55 participants
Conditions and interventions
Conditions
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent B-Cell Non-Hodgkin Lymphoma
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Refractory Adult Acute Lymphoblastic Leukemia
- Refractory B-Cell Non-Hodgkin Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Recurrent Transformed Non-Hodgkin Lymphoma
- Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- Recurrent B Acute Lymphoblastic Leukemia
- Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Refractory B Acute Lymphoblastic Leukemia
- Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Interventions
- Autologous Human Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ T-lymphocytes Biological
- Cyclophosphamide Drug
- Fludarabine Drug
- Laboratory Biomarker Analysis Other
- Leukapheresis Procedure
- Pharmacological Study Other
Biological · Drug · Other + 1 more
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 2, 2017
- Primary completion
- Mar 22, 2023
- Completion
- Mar 22, 2024
- Last update posted
- Apr 9, 2024
2017 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03103971, 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 Apr 9, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03103971 live on ClinicalTrials.gov.