CAR-T for R/R B-NHL

Phase 2

• Conditions: CAR - T CD19/CD20/CD22/CD30; Relapsed Non Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

• Registration Number: NCT03196830
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	One months after CAR-T cells were infused	Rate of complete remission and patial remission

Secondary Outcome Measures

Name	Time	Method
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	the survival of CAR-T cells detected in patients' peripheral blood
Adverse toxicity	Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused	Accordingto CTCAE 4.0 criteria

Trial Locations

Locations (1)

the First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China