CD19 targeted CAR-T therapy for patients with certain blood cancers
A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
This study is testing a new CAR-T therapy that uses specially modified immune cells to see if it can help patients with certain types of blood cancers like B Cell Leukemia and B Cell Lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 80 Years |
| Sex | All |
| Sponsor | Immune Cell, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, CART, Immunotherapy |
| Locations | 1 site (Weifang, Shandong) |
| Trial ID | NCT03383952 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and therapeutic effects of ICAR19 CAR-T cells, which are designed to specifically target and eliminate CD19+ tumor cells in patients with B Cell Leukemia and B Cell Lymphoma. Participants will receive multiple doses of these autologous T cells, and the study aims to determine how well they work in treating relapsed or refractory cases. The trial is in Phase 1, focusing on establishing the safety profile of this innovative immunotherapy approach.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with CD19 positive leukemia or lymphoma who have relapsed or are refractory to previous treatments.
Not a fit: Patients with active CNS dysfunction, uncontrolled infections, or those who have received certain recent treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a targeted treatment option that effectively eliminates cancer cells in patients with CD19+ blood cancers.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results in treating similar conditions, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: CD19 positive leukemia and lymphoma，relapsed and/or refractory： * survival\>12 weeks; * FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin; * LVEF≥50%; * Creatinine\<2.5mg/dl; * Bilirubin\<2.5mg/dl; * ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal; * At least 7 days after last chemotherapy; * provide with informed consent. Exclusion Criteria: * Active clinically significant CNS dysfunction * Pregnant or breast-feeding women. * Uncontrolled active infection including hepatitis B or C. * HIV positive. * Use of systemic steroids within 72 hours. * Allogeneic lymphocyte treatments within recent 6 months. * Any uncontrolled active medical disorder.
Where this trial is running
Weifang, Shandong
- Weifang People's Hospital — Weifang, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Xiulian Sun, MD.,Ph.D
- Email: xiuliansun@ymcell.com
- Phone: (+86) 010-62420659
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.