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
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedApril 16, 2019
April 1, 2019
4 years
June 20, 2017
April 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Rate of complete remission and patial remission
One months after CAR-T cells were infused
Secondary Outcomes (2)
Adverse toxicity
Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused
CAR-T cell survival
every week in first 4 weeks after CAR-T cells infusion, then every 3 months for 2 years, then every 6 months for next 2 years
Study Arms (1)
Treatment group
EXPERIMENTALthe group of patients who received CAR-T treatment
Interventions
For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Related Publications (5)
Zhou 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: 36131934DERIVEDSang 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: 35432352DERIVEDZhang 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: 34113569DERIVEDLi 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: 31335321DERIVEDQu 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: 31219975DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 23, 2017
Study Start
June 1, 2017
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
April 16, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share