Back to resultsCAR-T for R/R B-NHL
Primary Purpose
Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, CAR - T CD19/CD20/CD22/CD30
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CAR-T
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed Non Hodgkin Lymphoma focused on measuring Relapse/refractory non-Hodgkin lymphoma, CAR - T CD19/CD20/CD22/CD30
Eligibility Criteria
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
Sites / Locations
- the First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
the group of patients who received CAR-T treatment
Outcomes
Primary Outcome Measures
Overall Response Rate
Rate of complete remission and patial remission
Secondary Outcome Measures
Adverse toxicity
Accordingto CTCAE 4.0 criteria
CAR-T cell survival
the survival of CAR-T cells detected in patients' peripheral blood
Full Information
NCT ID
NCT03196830
First Posted
June 20, 2017
Last Updated
April 14, 2019
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03196830
Brief Title
CAR-T for R/R B-NHL
Official Title
Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, CAR - T CD19/CD20/CD22/CD30
Keywords
Relapse/refractory non-Hodgkin lymphoma, CAR - T CD19/CD20/CD22/CD30
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
the group of patients who received CAR-T treatment
Intervention Type
Biological
Intervention Name(s)
CAR-T
Intervention Description
For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Rate of complete remission and patial remission
Time Frame
One months after CAR-T cells were infused
Secondary Outcome Measure Information:
Title
Adverse toxicity
Description
Accordingto CTCAE 4.0 criteria
Time Frame
Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused
Title
CAR-T cell survival
Description
the survival of CAR-T cells detected in patients' peripheral blood
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cai-Xia Li
Phone
86 512 67781856
Email
licaixia@suda.edu.cn
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Chen, M.D.
Phone
+86 512 67781856
Email
chenjiasuzhou@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36131934
Citation
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.
Results Reference
derived
PubMed Identifier
35432352
Citation
Sang 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.
Results Reference
derived
PubMed Identifier
34113569
Citation
Zhang 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.
Results Reference
derived
PubMed Identifier
31335321
Citation
Li 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.
Results Reference
derived
PubMed Identifier
31219975
Citation
Qu 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.
Results Reference
derived
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CAR-T for R/R B-NHL
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