Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies

Summary

The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.

Conditions

• B-cell Acute Lymphoblastic Leukemia
• B-cell Lymphoma

Interventions

BIOLOGICAL

anti-CD19 UCAR-T cells

Dose range:1 to 5 ×10\^7 cells/Kg, Dose level one: 1×10\^7 cells/Kg, Dose level two: 3×10\^7 cells/Kg, Dose level three:5 ×10\^7 cells/Kg

DRUG

Fludarabine

30mg/m\^2 per day for 6 days

DRUG

Cytoxan

300mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline

DRUG

Melphalan

50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline

Sponsors & Collaborators

• Gracell Biotechnologies (Shanghai) Co., Ltd.

  collaborator INDUSTRY

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• Central South University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• The General Hospital of Western Theater Command

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  lead OTHER

Principal Investigators

• Xi Zhang, MD · Xinqiao Hospital of Chongqing

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-01

Primary Completion

2021-04-01

Completion

2022-04-01

Countries

• China

Study Locations