Clinical trial · Interventional
CAR-T for R/R B-NHL
Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma
NCT03196830CI-TRIAL-00113456completedPhase 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)
This study is a single arm study to investigate the efficacy and safety of CAR-T targeted CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for at least 2 years.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CAR - T CD19/CD20/CD22/CD30 | — | UNRESOLVED | — |
| Refractory Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- the group of patients who received CAR-T treatment
- interventionNames
- Biological: CAR-T
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- One months after CAR-T cells were infused
- description
- Rate of complete remission and patial remission
Secondary outcomes (2)
- measure
- Adverse toxicity
- timeFrame
- Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histological detection confirmed CD19/CD20/CD22/CD30 postive non-Hodgkin lymphoma * Recieved more than 2 lines of chemotherapy * With contraindications of hematopoietic stem cell transplantation or relapse after hematopoietic stem cell transplantation * Expected survival more than 3 months * Karmofsky performance score ≤ 60, and ECOG ≥ 2. * Enough organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT \< 2 × upper limitation of normal; SpO2 \> 92% * CBC results: Hb ≥ 80g/L, ANC \> 1 × 10E9/L, Plt ≥ 50 × 10E9/L * Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion * With measurable disease * Written informed consent could be acquired Exclusion Criteria: * Received immunol suppression treatment or steroids in recent 1 week before recruitment * Uncontrolled infection * HIV positive patients * Active HBV or HCV infection * Women in pregnancy and lactation * Refuse to conception control during treatment and 1 year after CAR-T infusion * Uncured malignancies other than non-Hodgkin lymphoma * Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma * Inheritated immune deficiancy * Severe heart disease
References
Publications (5)
- DERIVEDZhou J, Zhang Y, Shan M, Zong X, Geng H, Li J, Chen G, Yu L, Xu Y, Li C, Wu D. Cytopenia after chimeric antigen receptor T cell immunotherapy in relapsed or refractory lymphoma. Front Immunol. 2022 Sep 5;13:997589. doi: 10.3389/fimmu.2022.997589. eCollection 2022. PMID 36131934
- DERIVEDSang W, Wang X, Geng H, Li T, Li D, Zhang B, Zhou Y, Song X, Sun C, Yan D, Li D, Li Z, Li C, Xu K. Anti-PD-1 Therapy Enhances the Efficacy of CD30-Directed Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed/Refractory CD30+ Lymphoma. Front Immunol. 2022 Apr 1;13:858021. doi: 10.3389/fimmu.2022.858021. eCollection 2022. PMID 35432352
- DERIVEDZhang Y, Li J, Lou X, Chen X, Yu Z, Kang L, Chen J, Zhou J, Zong X, Yang Z, Li M, Xu N, Jia S, Geng H, Chen G, Dai H, Tang X, Yu L, Wu D, Li C. A Prospective Investigation of Bispecific CD19/22 CAR T Cell Therapy in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma. Front Oncol. 2021 May 25;11:664421. doi: 10.3389/fonc.2021.664421. eCollection 2021. PMID 34113569
- DERIVEDLi C, Zhang Y, Zhang C, Chen J, Lou X, Chen X, Kang L, Xu N, Li M, Tan J, Sun X, Zhou J, Yang Z, Zong X, Wang P, Xu T, Qu C, Huang H, Jin Z, Yu L, Wu D. Comparation of CART19 and autologous stem-cell transplantation for refractory/relapsed non-Hodgkin's lymphoma. JCI Insight. 2019 Jul 23;5(17):e130195. doi: 10.1172/jci.insight.130195. PMID 31335321
- DERIVEDQu C, Ping N, Kang L, Liu H, Qin S, Wu Q, Chen X, Zhou M, Xia F, Ye A, Kong D, Li C, Yu L, Wu D, Jin Z. Radiation Priming Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma With High Tumor Burden. J Immunother. 2020 Jan;43(1):32-37. doi: 10.1097/CJI.0000000000000284. PMID 31219975