CAR-T for R/R B-NHL

Phase 2

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

• 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

Arm && Interventions

Group	Intervention	Description
Treatment group	CAR-T	the group of patients who received CAR-T treatment

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
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
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

Trial Locations

Locations (1)

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