Clinical trial · Interventional
Study Evaluating the Efficacy and Safety With CAR-T Immunotherapy for CD19 Positive Lymphoma
Open, Single Arm,Multicenter Phase 2 Clinical Study to Evaluating the Efficacy and Safety of the Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) for CD19 Positive 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)
This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the CD19 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times
- interventionNames
- Biological: The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)
Primary outcomes (1)
- measure
- The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy.
- timeFrame
- up to 90 days
- description
- The objective reaction rate will be determined by the evaluation of CT/PET-CT.Evaluation of the objective reaction rate according to the non-hodgkin's lymphoma curative effect evaluation criteria of international lymphoma group. The objective reaction rate = (complete remission (CR) number + partial remission (PR) number / total number of cases receiving treatment.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Age older than 16 years old,gender and race no limited. * 2.Pathological diagnosis of CD19 express positive recurrent or refractory B lymphoma, satisfy any of the following a diagnosis of recurrent or refractory lymphoma: (1) According to the standard solution standardization more than four courses of treatment, tumor size \< 50% or progression;(2) According to the standard solution treatment of complete remission, after recurrence again with the original plan or the national expert consensus recommended second-line cannot again get to complete remission (3) Relapse after hematopoietic stem cell transplantation. * 3.Patients into the group needs lesions to be available for testing or evaluating disease. * 4.ECOG score reaches 0 to 1 points. * 5.Patients into the group of White Blood Cell counts in peripheral blood acuity≥ 1.0 x10\^9 / L. * 6.Estimated survival times \> 90 days. * 7.Patients have self-knowledge ability, can sign the informed consent form. Exclusion Criteria: * 1.Pregnant or lactating women. * 2.Uncontrolled infection. * 3.HIV infection, hepatitis B or C activity period. * 4.Patients who need long-term immunosuppressive therapy (Such as allergies, autoimmune diseases, GVHD, etc.) * 5.Combined activity of the central nervous system malignant tumor invasion. * 6.Abnormal coagulation function, patients with severe thrombosis. * 7\. Organ failure Heart:class Ⅱ or above. Liver:class Ⅱ or above( Refer to Classification of Wuhan Conference (1983)). Kidney: The second stage of renal insufficiency or above. Lung: class Ⅱdecreased slightly or above. Brain: The central nervous system transfer or have active lesions. * 8.Patients who have participated in other clinical trials in the past 30 days or or participate in other clinical trials at the same time. * 9.Investigator believe that the patient is not suitable to participate in the study.
References
Publications (1)
- BACKGROUNDTurtle CJ, Hanafi LA, Berger C, Hudecek M, Pender B, Robinson E, Hawkins R, Chaney C, Cherian S, Chen X, Soma L, Wood B, Li D, Heimfeld S, Riddell SR, Maloney DG. Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells. Sci Transl Med. 2016 Sep 7;8(355):355ra116. doi: 10.1126/scitranslmed.aaf8621. PMID 27605551