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CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma

NCT03029338•Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10\^6/kg-1×10\^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.

Detailed Description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell lymphoma.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell lymphoma.
•Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
•Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min.
•Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
•Patients should sign informed consent form.

Exclusion Criteria

•Patients with central nervous system involvement by lymphoma.
•Prior chemotherapy within 2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load.
•Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have≥ grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.
•Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
•Major surgery within 4 weeks before enrollment.
•Impaired cardiac function:Ejection fraction ≤45 % on MUGA scan. QTc interval \> 450msecs on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
•Administration of live vaccine ≤ 4 weeks before enrollment.
•Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Key Dates

Start Date

June 8, 2017

Primary Completion Date

May 22, 2019

Completion Date

June 22, 2021

Last Updated

February 11, 2026

Enrollment

ACTUAL participants

Conditions

Lymphomas Non-Hodgkin's B-CellRelapse

Interventions

CD19 CAR T cells

BIOLOGICAL

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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RECRUITINGPHASE1

U69-CART-Cells For R/R T-ALL

NCT07350863

Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

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RECRUITINGPHASE1/PHASE2

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

U69-CART-Cells For R/R T-ALL

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Elranatamab in R/R Multiple Myeloma

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)