Universal CAR T cell therapy for B cell malignancies
Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies
PHASE1 · Shenzhen Geno-Immune Medical Institute · NCT05995015
This study is testing a new type of off-the-shelf CAR T cell therapy to see if it can effectively treat patients with certain B cell cancers.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Months to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute (other) |
| Drugs / interventions | CAR-T, CAR T, Chimeric antigen receptor, chemotherapy |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05995015 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, feasibility, and efficacy of a novel universal CAR T cell product, 4SCAR19U T cells, designed to treat CD19-positive B cell malignancies. Unlike traditional CAR T therapies that are custom-made for each patient, these cells are manufactured in bulk and can be administered off-the-shelf, addressing urgent treatment needs. The study aims to assess how well these engineered T cells function and persist in patients, potentially overcoming limitations associated with autologous T cells. It is a Phase 1 trial enrolling patients from multiple clinical centers.
Who should consider this trial
Good fit: Ideal candidates include patients over 6 months old with CD19-positive B cell malignancies and a KPS score above 80.
Not a fit: Patients with active infections, other serious diseases, or those who have previously failed CAR-T treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide timely and effective treatment options for patients with aggressive B cell malignancies.
How similar studies have performed: While CAR T cell therapies have shown success in treating B cell malignancies, the universal approach of this study is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age older than 6 months. 2. Primary B cell surface expression of CD19. 3. The KPS score over 80 points, and survival time is more than 1 month. 4. Greater than Hgb 80 g/L. 5. No contraindications to blood cell collection. Exclusion Criteria: 1. Accompanied with other active diseases, and difficult to assess response after treatment. 2. Bacterial, fungal, or viral infection, unable to control. 3. Living with HIV. 4. Active HBV or HCV infection. 5. Pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. Prior failed CAR-T treatment.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-Immune Medical Institute — Shenzhen, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Lung-Ji Chang, Ph.D
- Email: c@szgimi.org
- Phone: +86-0755 8672-5195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: B Cell Malignancies, Universal CAR-T, CD19 B-ALL, PMBCL, CNS-BCL, BCL