A Phase I Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Adult Subjects With Relapsed/Refractory CD19+ B Cells Acute Lymphoblastic Leukemia(CALL-1)

Shanghai AbelZeta Ltd.1 site in 1 country20 target enrollmentJanuary 2017

ConditionsRelapsed or Refractory Acute Lymphoblastic Leukemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor: Shanghai AbelZeta Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Dose-limiting toxicity (DLT)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)

Detailed Description

This is a single-center, Open Label phase I clinical trial, 20 subjects planned to be enrolled. The trial have two stages (Phase I dose-escalation clinical trial and phase I dose expansion trial).Subjects will be divided into low-dose group, medium-dose group and high-dose group.Additional patients will be enrolled to confirm the optimal dose Dose CAR+ cells/kg Low 0.5×106 Medium 1.5×106 High 3.0×106

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

November 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai AbelZeta Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 14-75 years old, male or female.
•Volunteered to participate in this study and signed written informed consent form.
•Histologically diagnosed as CD19+B-ALL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2016 version 1).
•Relapsed or refractory CD19+B-ALL (meet one of the following conditions)
•Refractory as defined not achieving a CR(complete remission, morphology\<5% blasts) after two cycles of standard chemotherapy regimen.
•Duration of remission ≤ 12 months after the first induction chemotherapy regimen.
•Refractory disease after one or more salvage therapies.
•Two or more Bone Marrow relapse.
•Morphological disease in the bone marrow (≥ 5% blasts).
•Subjects with Philadelphia chromosome negative(Ph-) disease, or subjects with Philadelphia chromosome positive(Ph+) disease that are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated are eligible.

Exclusion Criteria

•History of severe allergic disease or allergic to one or more drugs.
•Any kind of these laboratory testing: serum total bilirubin≧1.5mg/dl, serum albumin≦35g/L, ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, platelets≦50×109/L.
•Extramedullary disease.
•Relapsed disease after allogeneic hematopoietic stem cell transplantation.
•Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis.
•Subjects with concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome.
•Subjects with grade III or above severe hypertension(WHO/ISH Guidelines for the Management of Hypertension, 1999).
•History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months prior to enrollment.
•Subjects with class III and IV heart failure according to the NYHA Heart Failure Classifications;
•History of QT prolongation with clinically significant arrhythmias.