Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies

Summary

The prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19 CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical experiments is cheerful.however, how to select the functional T cells from the malignant T cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of the host as the material of anti-CD7 universal CAR-T cells could be accessible and affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies.

Conditions

• T-cell Leukemia
• T-cell Lymphoma

Interventions

BIOLOGICAL

CD7 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

600mg/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

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-06-01

Completion

2023-06-01

Countries

• China

Study Locations