4SCAR-T Therapy Post CD19-targeted Immunotherapy

NCT04430530 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-12

No results posted yet for this study

Summary

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Conditions

  • CD19 Negative B-cell Malignancies

Interventions

BIOLOGICAL

Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20

Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies

Sponsors & Collaborators

  • ShiJiaZhuang Zhongxi Children Hospital

    collaborator UNKNOWN
  • Shenzhen Children's Hospital

    collaborator OTHER_GOV
  • The Seventh Affiliated Hospital of Sun Yat-sen University

    collaborator OTHER
  • Shenzhen Geno-Immune Medical Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2023-05-31
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT04430530 on ClinicalTrials.gov