CAR-T for R/R B-NHL

Refractory Non-Hodgkin Lymphoma Clinical Trial

Official title:

Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03196830
• Other study ID #: SZ5601
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2019
• Source: The First Affiliated Hospital of Soochow University
• Contact: Cai-Xia Li
• Phone: 86 512 67781856
• Email: licaixia[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• CAR - T CD19/CD20/CD22/CD30
• Lymphoma
• Lymphoma, Non-Hodgkin
• Refractory Non-Hodgkin Lymphoma
• Relapsed Non Hodgkin Lymphoma

Intervention

Biological:
• CAR-T
For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	Rate of complete remission and patial remission	One months after CAR-T cells were infused
Secondary	Adverse toxicity	Accordingto CTCAE 4.0 criteria	Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused
Secondary	CAR-T cell survival	the survival of CAR-T cells detected in patients' peripheral blood	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