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

NCT03029338 | Completed Phase 1

• 1 other identifier: QT2016003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphomas Non-Hodgkin's B-Cell; Relapse

Keywords

lymphoma; non-hodgkin; B-cell; CD19 CAR T cells; refractory; relapse

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  2 years

Secondary Outcomes (4)

• Severity of the adverse events

  2 years

• Response rate

  12 months

• Progression-free survival(PFS)

  2 years

• Persistence of CAR T cells in vivo

  2 years

Study Arms (1)

CD19 CAR T cells

EXPERIMENTAL

CD19 CAR T cells 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.

Biological: CD19 CAR T cells

Interventions

CD19 CAR T cells BIOLOGICAL

CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.

CD19 CAR T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Juventas Cell Therapy Ltd.: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

Location

Related Publications (1)

• Liu W, Xie T, Zhang Z, Huang W, Liu H, Sui W, Deng S, Lv R, Wang Y, Wang Q, Xiong W, Xu Y, Lv L, Ma Y, Qiu L, Wang J, Zou D. Long-term outcomes of CNCT19 chimeric antigen receptor T-cell therapy in relapsed or refractory aggressive B-cell lymphoma. Chin Med J (Engl). 2025 Sep 17. doi: 10.1097/CM9.0000000000003716. Online ahead of print.

  PMID: 40960310 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell; Recurrence; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dehui Zou, Dr.

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: June 8, 2017
• Primary Completion: May 22, 2019
• Study Completion: June 22, 2021
• Last Updated: February 11, 2026

Record last verified: 2022-01

Locations

CN (1)