CAR-T for R/R B-NHL

Soochow University

Status and phase

Unknown

Phase 2

Conditions

CAR - T CD19/CD20/CD22/CD30

Relapsed Non Hodgkin Lymphoma

Refractory Non-Hodgkin Lymphoma

Treatments

Biological: CAR-T

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03196830

SZ5601

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

6 to 65 years old

Volunteers

No Healthy Volunteers

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