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Recruiting NCT04430530

4SCAR-T Therapy Post CD19-targeted Immunotherapy

Phase I / Phase II Interventional CD19 Negative B-cell Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20.
Who it may be relevant to
Registry conditions: CD19 Negative B-cell Malignancies. Basic parameters: 6 months — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

4SCAR-T Therapy After Anti-CD19 Immunotherapy Targeting B Cell Acute Lymphoblastic Leukemia

Overview

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.

Detailed description

Anti-CD19 immunotherapy based on antibody conjugated drugs or CD19-CAR-T cells has demonstrated unprecedented positive response in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many patients still relapse and up to 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.

Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, the 4th generation CAR gene-modified T cells targeting CD22, CD10, CD20, CD38, or CD123 have been considered in post anti-CD19 treatment. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-escaped 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

Primary outcome measures

  • Safety of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells [Time frame: 24 weeks]
Secondary outcome measures (1)
  • Anti-tumor activity of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Age older than 6 months.
  • B cell malignancies relapsed after anti-CD19 immunotherapy.
  • Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20.
  • The KPS score over 80 points, and survival time is more than 1 month.
  • Greater than Hgb 80 g/L.
  • No contraindications to blood cell collection.

Exclusion criteria

  • Complications with other active diseases, and difficult to assess patient response.
  • Bacterial, fungal, or viral infection unable to control.
  • Living with HIV.
  • Active HBV and HCV infection.
  • Pregnant and nursing mothers.
  • Under systemic steroid use within a week of the treatment.
  • Judged difficult to cooporate for continued evaluation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shenzhen Geno-Immune Medical Institute — Shenzhen

Identifiers

NCT: NCT04430530 · GIMI-IRB-20008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗