Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T Cells for B-cell Leukemia/Lymphoma

Summary

This is a single-arm open-label phase I/II study to determine the relative superiority of αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. In this trial, all subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number to test a hypothesis that CD137-costimulation can promote the persistence and engraftment of CAR-T cells and this superiority can lead to improved progression-free survival.

Conditions

• Hematopoietic/Lymphoid Cancer
• Adult Acute Lymphoblastic Leukemia in Remission
• B-cell Adult Acute Lymphoblastic Leukemia
• B-cell Chronic Lymphocytic Leukemia
• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage III Chronic Lymphocytic Leukemia
• Stage III Grade 1 Follicular Lymphoma
• Stage III Grade 2 Follicular Lymphoma
• Stage III Grade 3 Follicular Lymphoma
• Stage III Mantle Cell Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma
• Stage IV Chronic Lymphocytic Leukemia
• Stage IV Grade 1 Follicular Lymphoma
• Stage IV Grade 2 Follicular Lymphoma
• Stage IV Grade 3 Follicular Lymphoma
• Stage IV Mantle Cell Lymphoma

Interventions

BIOLOGICAL

anti-CD19 CAR-T

Ex vivo-expanded autologous T cells modified to express CD19 CAR

DRUG

Fludarabine

DRUG

Cyclophosphamide

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Xuzhou Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Zhi Cheng, M.D. · The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2017-12-31

Completion

2019-12-31

Countries

• China

Study Locations