T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma
TerminatedPhase 1Results postedLast updated 15 February 2022
What this trial tests
Phase 1 trial testing Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells in Lymphoma, B-Cell in 2 participants. Terminated before completion.
Timeline
20 December 2019
Primary endpoint 11 June 2021
11 June 2021
Quick facts
Lead sponsor
National Cancer Institute (NCI)
Phase
Phase 1
Status
Terminated
Study type
INTERVENTIONAL
Allocation
non randomized
Design
sequential
Masking
none
Primary purpose
treatment
Enrollment
2
Start date
20 December 2019
Primary completion
11 June 2021
Estimated completion
11 June 2021
Sites
1 location across United States
Drugs / interventions tested
Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells
18 and older, any sex, with Lymphoma, B-Cell or Lymphoma, Non-hodgkins. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Administered T Cells Expressing a Novel Fully- Human Anti-cluster of Differentiation 19 (CD19) and Anti-cluster of Differentiation 20 (CD20) Chimeric Antigen Receptors (CAR) Who Experienced a Dose-limiting Toxicity (DLT)Primary· First protocol treatment through 28 days after the CAR T-cell infusion.
A DLT are defined as toxicities assessed by the Common Terminology Criteria for Adverse Events v5.0 that are possibly, probably, or definitely attributable to protocol interventions and occurring between the first protocol treatment through 28 days after the CAR T-cell infusion.
Peripheral Motor Neuropathy Possibly Related
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
1
2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase
0
Guillain-Barre Syndrome Possibly Related
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
1
2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase
0
Percentage of Peak Blood Chimeric Antigen Receptors (CAR) T CellsSecondary· 119 days after CAR T-cell infusion
We measured CAR T-cell persistence by detecting the CAR gene in peripheral blood mononuclear cells (PBMC) by polymerase chain reaction (PCR).
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
10.5
Percentage of Peripheral Blood Mononuclear Cells (PBMC) of Chimeric Antigen Receptors (CAR) T CellsSecondary· pretreatment and multiple days from day 1 to day 173 after infusion.
Peak blood levels of Chimeric Antigen Receptors (CAR) T cells were measured by exact Wilcoxon rank sum test.
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
10.47
Number of Participants With Clinical ResponseSecondary· Approximately 1 year 5 months
Response for lymphoma was assessed by the Revised Response Criteria for Malignant Lymphoma and The Lugano Classification. Complete Remission (CR) is complete disappearance of all detectable clinical evidence of disease. Partial Remission (PR) is ≥ 50% decrease in nodes or masses. Progressive Disease (PD) is Response ≥ 50% increase in a single node. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor PD. For participants with Chronic Lymphocytic Leukemia (CLL),response was assessed by the International Workshop on CLL. CR is no lymph nodes ≥ 1.5 cm on physical exam or rele
Complete Remission
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
0
Partial Remission
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
1
Progressive Disease
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
0
Stable Disease
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
0
Last Time-Point at Which Chimeric Antigen Receptors (CAR) T Cells Were Detected in the BloodSecondary· 119 days after CAR T-cell infusion
Chimeric Antigen Receptors (CAR) T cell persistence was measured in the blood by quantitative polymerase chain reaction (PCR). CAR T cells that are detected in the participant's blood that persist for a significant length of time is a positive finding.
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
119
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)Secondary· Date treatment consent signed to date off study, approximately 7 months and 18 days.
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one
Group
Value
95% CI
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
1
2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase
0
Maximum Tolerated Dose (MTD) of Chimeric Antigen Receptors (CAR) T CellsSecondary· First protocol treatment through 28 days after the CAR T-cell infusion.
The maximum tolerated dose is the dose at which a maximum of 1 of 6 participants has a dose-limiting toxicity (DLT). A DLT are defined as toxicities that are possibly, probably, or definitely attributable to protocol interventions and occurring between the first protocol treatment through 28 days after the CAR T-cell infusion.
Group
Value
95% CI
All Participants
NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 7 months and 18 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation
Serious: 1/1 (100%)
Deaths: 0/1
2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase
Serious: 0
Deaths: 0
Serious adverse events (5 terms)
Reaction
System
1/Conditioning Chemotherap…
2/Conditioning Chemotherap…
Dysphagia
Gastrointestinal disorders
—
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06609304 — Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
· Phase 4
· recruiting
NCT06866873 — CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
· NA
· recruiting
NCT06381830 — Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 15 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04160195.