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NCT05995015Not yet recruitingPhase 1

4SCAR19U T Cells Targeting B Cell Malignancies

Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
8 Aug 2023
Start date
31 Dec 2026
Primary completion date
31 Dec 2029
Lead sponsor
Shenzhen Geno-Immune Medical Institute
NCT number
NCT05995015

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 30
  • From 31 Dec 2026 to the primary completion date, 31 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • under systemic steroid treatment within a week of the treatment.
  • Prior failed CAR-T treatment.

Other illness

  • Accompanied with other active diseases, and difficult to assess response after treatment.
  • Bacterial, fungal, or viral infection, unable to control.
  • Living with HIV.
  • Active HBV or HCV infection.

Other

  • Pregnant and nursing mothers.

Who the study is looking for

  • Age older than 6 months.
  • Primary B cell surface expression of CD19.
  • 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.

Age in the registry: 6 months to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shenzhen Geno-immune Medical Institute
Coordinator of this site? Confirm its status
ShenzhenChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.