ALL
Conditions
Keywords
CD19 CAR-T
Brief summary
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Detailed description
This study is a single-arm, open-label, multicenter clinical trial that plans to enroll approximately 50 adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia to undergo CD19 CAR-T cell therapy. The primary objective is to evaluate the efficacy of CD19 CAR-T therapy in adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia. The secondary objective is to assess the safety of CD19 CAR-T therapy in this patient population. The exploratory objectives include evaluating the in vivo expansion and persistence of CAR-T cells, as well as B-cell depletion.
Interventions
DRUGCD19 CAR-T cells
Each subject receive CD19/CD22 CAR T-cells by intravenous infusion
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old, gender not restricted; 2. Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias; 3. Abnormal B cells positive for CD19 and CD22 by immunophenotyping; 4. Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing; 5. Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens; 6. Serum total bilirubin ≤ 51 μmol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol/L; 7. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography; 8. Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation; 9. Estimated survival time ≥ 3 months; 10. ECOG performance status score 0-2; 11. Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion; 12. Subjects voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
* Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Molecular Response Rate after CD19 CAR-T Cell Therapy | 28 days after infusion | Laboratory tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leukemia-Free Survival | 2 years after infusion | Survival follow-up |
| Overall survival | 2 years after infusion | Survival follow-up |
| Cumulative Incidence of Relapse | 2 years after infusion | Laboratory tests |
| Complete Molecular Response Rate after CD22 CAR-T Cell Therapy | 2 years after infusion | Laboratory tests |
Countries
China
Contacts
Primary ContactHe Huang, MD
Backup ContactYongxian Hu
Outcome results
None listed