Clinical trial · Interventional
Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma.
Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma
NCT03929107CI-TRIAL-00038345unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma patients.
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 |
|---|---|---|---|
| B Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- In this group, patients will be treated with Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T, and the safety and efficacy will be evaluated.
- interventionNames
- Biological: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells
Primary outcomes (2)
- measure
- complete remission rate
- timeFrame
- at the time point 3 months after CAR-T cell transfusion
- description
- complete remission rate after treated by CAR-T therapy
- measure
- adverse events
- timeFrame
- from the date of the start of treatment to 24 months after last patient's enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age 18-75 years old, male or female; * 2\. ECOG 0-3, for patients with ECOG=4, if ECOG reach 0-3 after bridging treatment with ibrutinib, they are also considered to fit this criteria; * 3\. Histologically diagnosed as B cell non-Hodgkin's lymphoma (NHL)(according to WHO 2008 criteria), including DLBCL-NOS, primary mediastinal B cell lymphoma (PMBCL) mantel cell lymphoma (MCL), transformed follicular lymphoma (TFL) and other transformed B cell NHL; * 4\. CD19 positive (by immuno-histology or flowcytometry) \[for DLBCL/PMBCL/TFL patients, negative CD19 immuno-histology results also acceptable\]; * 5\. Definition of relapsed and refractory disease: 1) refractory DLBCL should fit one of the following: ①complete remission NOT achieved after 2nd line treatment; ②progression of disease during treatment; ③duration of stable disease \<6 months; ④ disease progress or relapse within 12 months of autologous stem cell transplantation. 2\) definition of refractory/relapsed disease for CLL and other indolent B cell NHL, should fit one of the following: ① failed or relapsed after 2nd therapy (Rituximab must be included) and being unable to accept ibrutinib treatment due to various reasons; ② non-responsive or intolerable to ibrutinib as 2nd line treatment; 3) refractory or relapsed MCL should fit one of the following: ① complete remission not achieved after 2nd line treatment; ② disease progression during treatment; ③duration of stable disease ≤6 months; ④disease progress or relapse within 12 months of autologous stem cell transplantation. * 6\. Previous treatment of aggressive B lymphomas must include Rituximab and anthracyclines; * 7\. Patients should have at least one measurable disease focus, with the longitudinal diameter ≥1.5cm, or any extra-nodal focus with the longitudinal diameter ≥1.0cm, with PET/CT positive results; * 8\. Blood routine test, absolute neutrophil count≥1000/ul、platelet count≥45000/ul; * 9\. Cardiac, hepatic and renal function: Creatinin \<1.5 times of normal maximum;ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of ULN;cardiac ejection fraction≥ 50%; * 10\. Patients should have the ability to fully understand contents of the written consent and be willing to sign the written consent; * 11\. Fertile patients should agree to take contraceptive measures during the process of this trial. Exclusion Criteria: * 1\. History of other malignant tumor; * 2\. History of autologous stem cell transplantation within 6 weeks prior to enrollment; * 3\. Received CAR-T therapy within 3 months prior to enrollment; * 4\. Received cytotoxic medicine or glucocorticoids or other targeted-therapy medicine (except for ibrutinib) within 2 weeks prior to T cell collection; * 5\. With active autoimmune disease; * 6\. With active infection; * 7\. With HIV infection, or uncontrolled HBV/HCV/syphilis infection; * 8\. With known central nervous system lymphoma.
References
Publications (0)
Data not yet available
No reference posted for this study.