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Not yet taking people in ChinaPhase 1/2

Modified immune cells tested in leukemia that stopped responding to CD19 therapy

Tests modified T cells in people with CD19-negative acute lymphoblastic leukemia.

Key facts

Who runs it
Shenzhen Geno-Immune Medical Institute
Where
Shenzhen, ChinaSee the site
Trial code
Registry title
CAR-T Immunotherapy Targeting CD19- ALL
Status
Not yet recruiting
Phase
Phase 1/2
People taking part
100 people, planned
Starts
1 Jul 2027
Expected to end
30 Jun 2029
Type of study
Interventional
Treatments tested
  • 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 6 months to 75 years whose B-cell leukemia has no CD19 marker, or has come back after CD19 CAR-T treatment. It tests CAR-T cells aimed at other markers on the leukemia cells.

Age
6 months to 75 years
Sex
All sexes can join.
Disease stage
B-cell cancer with no CD19 marker from the start, or relapse after CD19 CAR-T treatment. The cancer cells must carry one or more of CD22, CD123, CD38, CD10, CD20 or TSLPR.
Earlier treatment
Relapse after CD19 CAR-T treatment is one way in. No systemic steroids within a week of treatment.
Biomarker or test result
CD19 negative cancer cells that show one or more of CD22, CD123, CD38, CD10, CD20 or TSLPR.

Main reasons for not taking part

  • Other active diseases that make it hard to judge the response
  • Infection with bacteria, fungus or virus that cannot be controlled
  • Living with HIV
  • Active HBV or HCV infection
  • Pregnant or nursing mothers

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Age older than 6 months
  • Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy
  • Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR
  • 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

Who cannot take part

  • Under systemic steroid use within a week of the treatment
  • Complications with other active diseases, and difficult to assess patient response
  • Bacteria, fungus, or virus infection, and unable to control
  • Living with HIV
  • Active HBV and HCV infection
  • Pregnant and nursing mothers

Where in China

  • Shenzhen Geno-immune Medical InstituteShenzhen, ChinaContact: Lung-Ji Chang, PhDNo longer taking part

About the trial

What the trial wants to find out

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development 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.

The group in the trial

  • 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPRTreatment being tested

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia
Plain-language title
Modified immune cells tested in leukemia that stopped responding to CD19 therapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 November 2026