Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
Clinical Research of Gene Therapy for Refractory B-Cell Non-Hodgkin Lymphoma Using Autologous T Cells Expressing a Chimeric Antigen Receptor Specific to the CD19 Antigen
The purpose of this study is to evaluate the safety, efficacy and blood kinetics of autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.
Peripheral blood (up to 600 mL) will be collected from a subject after obtaining a written
informed consent and completing the 1st registration. Peripheral blood mononuclear cells
(PBMCs) and plasma are obtained from the blood, and T cells contained in the PBMCs are
transduced with anti-CD19 CAR gene by using SFG-1928z retroviral vector. Anti-CD19 CAR
expressing T cells (CD19-CAR-T) will be expanded using a medium containing autologous
plasma. After the T cells pass in quality control tests, the subject will go into 2nd
registration. Subjects will be hospitalized and administered Cyclophosphamide on Day -2 or
Bendamustine on Day -3 to Day -2 intravenously as Pre-treatment, and then subjects will
receive 1st infusion of CD19-CAR-T on Day 0 and Day 1 (Day 1：1/3 dose, Day 2：2/3 dose) as a
split dose. In case the sufficient cell number of CD19-CAR-T is manufactured, DLT is not
observed after CD19-CAR-T infusion, certain clinical effect is observed and additional
treatment is preferable, the necessity of 2nd infusion will be assessed. In the case that
2nd infusion is necessary, it is allowed to infuse at appropriate timing.
This study is conducted based on the 3+3 dose escalation scheme. Three subjects are enrolled
in each group of Dose Level. If one of the 3 subjects show DLT during DLT assessment period,
another 3 subjects will be added; therefore, decision as to whether the next Dose Level can
follow or not is made based on the results obtained from the total of 6 subjects.
The investigator assesses the tumor shrinkage effect of CD19-CAR-T in accordance with
"Revised response criteria malignant lymphoma", at 12 week after the 1st infusion of
CD19-CAR-T (or at the time of termination). The investigator also assesses the safety during
the follow-up period. Long-term follow-up study is conducted at frequency of once a year for
15 years after the 1st infusion of CD19-CAR-T in reference to guidelines of FDA.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05105867 -
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
|
Early Phase 1 | |
| Active, not recruiting |
NCT05008055 -
Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
|
Phase 2 | |
| Recruiting |
NCT06189391 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN201
|
Phase 1 | |
| Enrolling by invitation |
NCT05797948 -
GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
|
N/A |