Clinical trial · Interventional
CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphomas Non-Hodgkin's B-Cell | B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CAR T cells
- description
- 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.
- interventionNames
- Biological: CD19 CAR T cells
Primary outcomes (1)
- measure
- Number of patients with adverse events
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Severity of the adverse events
- timeFrame
- 2 years
- measure
- Response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLiu W, Xie T, Zhang Z, Huang W, Liu H, Sui W, Deng S, Lyu R, Wang Y, Wang Q, Xiong W, Xu Y, Lyu 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). 2026 May 5;139(9):1367-1374. doi: 10.1097/CM9.0000000000003716. Epub 2025 Sep 17. PMID 40960310