T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma
Public ClinicalTrials.gov record NCT04160195. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: -Cluster of differentiation 19 (CD19) and cluster of differentiation 20 (CD20) are often found on certain cancer cells. Researchers think that a person's T cells can be modified in a lab to kill cells that have CD19 and CD20 on the surface. Objective: -To see if it is safe to give anti-CD19 and anti-CD20 CAR T cells to people with a B cell cancer or Hodgkin lymphoma. Eligibility: -People ages 18 and older with a B cell cancer or Hodgkin lymphoma that has not been controlled with standard therapies Design: * Participants will be screened under protocol 01C0129 with: * Medical history * Physical exam * Blood and heart tests * Bone marrow biopsy: A needle is inserted into the participant's hip bone to remove a small amount of marrow. Scans * Participants will have apheresis: Blood will be removed through a vein. The blood with circulate through a machine that removes the T cells. The rest of the blood will be returned to the participant. * Once a day for 3 days before they get the T cells, participants will receive chemotherapy through a vein. * Participants will receive the T cells through a vein. They will stay in the hospital for at least 9 days. * Participants may have a lumbar puncture: A needle will remove fluid from the spinal cord. * Participants may have a tumor biopsy. * Participants will repeat the screening tests throughout the study. * Participants will have follow-up visits 2 weeks after infusion; monthly for 4 months; at 6, 9, and 12 months; every 6 months for 3 years; and then annually for 5 years. Participants will then be contacted annually for 15 years.
Study identification
- NCT ID
- NCT04160195
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 2 participants
Conditions and interventions
Conditions
Interventions
- Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells Biological
- Cyclophosphamide Drug
- Fludarabine Drug
Biological · Drug
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
- Dec 19, 2019
- Primary completion
- Jun 10, 2021
- Completion
- Jun 10, 2021
- Last update posted
- Feb 14, 2022
2019 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
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 NCT04160195, 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 Feb 14, 2022 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04160195 live on ClinicalTrials.gov.