CAR - T CD19/CD20/CD22/CD30, Refractory Non-Hodgkin Lymphoma, Relapsed Non Hodgkin Lymphoma
Conditions
Keywords
Relapse/refractory non-Hodgkin lymphoma, CAR - T CD19/CD20/CD22/CD30
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.
Interventions
BIOLOGICALCAR-T
For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy
Sponsors
The First Affiliated Hospital of Soochow University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | One months after CAR-T cells were infused | Rate of complete remission and patial remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed