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Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT

NCT04516551 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-17

No results posted yet for this study

Summary

The patients with relapsed B cell acute lymphoblastic leukemia (ALL) after hematopoietic stem cell transplant (HSCT) have a poor prognosis, especially for these relapsed in a short time after transplantation. Nowadays there is no effective way to salvage patients in such conditions. T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability, which makes it serve well for patients with relapsed B-ALL. So we launched a multi-center clinical trial to proved the safety and efficacy of anti-CD19 CAR-T cells for relapsed B cell ALL.

Conditions

  • Relapsed Adult ALL
  • B Cell Leukemia

Interventions

BIOLOGICAL

anti-CD19 allo-CAR-T cells

The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.

Sponsors & Collaborators

  • Gracell Biotechnologies (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • The Affiliated Hospital Of Guizhou Medical University

    collaborator OTHER

  • The General Hospital of Western Theater Command

    collaborator OTHER

  • Chongqing University Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

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

    collaborator OTHER

  • Xinqiao Hospital of Chongqing

    lead OTHER

Principal Investigators

  • Xi Zhang, MD phD · Xinqiao Hospital of Chongqing

  • He Huang, MD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2021-12-01
Completion
2022-12-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516551 on ClinicalTrials.gov