Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma
| Registry | NCT03196830 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 168 (Actual) |
| Sponsor | The First Affiliated Hospital of Soochow University (Other); collaborators: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd |
| Conditions | Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, CAR - T CD19/CD20/CD22/CD30 |
| Interventions | CAR-T (Biological) |
| Dates | start 2017-06-01, primary completion 2024-01-31, completion 2024-01-31, first posted 2017-06-23, last updated 2026-06-03 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Relapsed Non Hodgkin Lymphoma All trials for Refractory Non-Hodgkin Lymphoma All trials of CAR-T
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment group | Experimental | Biological: CAR-T | the group of patients who received CAR-T treatment |
Sex: All, ages: 6 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| the First Affiliated Hospital of Soochow University | Suzhou, Jiangsu | China |