Safety and Efficacy of PRG-2302 for Refractory or Relapsed B-cell Acute Lymphoblastic Leuk
A Clinical Study on the Safety and Effectiveness of CD19/CD22 Chimeric Antigen Receptor T Cells in the Treatment of Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.
| Condition(s) | Acute Lymphoblastic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | A Clinical Study on the Safety and Effectiveness of CD19/CD22 Chimeric Antigen Receptor T Cells in the Treatment of Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease. |
| Who can participate | Inclusion Criteria: 1. Age ≥18 years old, not over 70 years old (including 70 years old); 2. Meet the following diagnostic criteria for recurrent or refractory B-ALL: A clear diagnosis of B-cell acute lymphoblastic leukemia with any of the following conditions Patients: * recurrent: recurrence within 12 months after the first remission after standard treatment; * refractory: 1.induction No remission after more than 6 weeks of treatment or two courses of induction therapy; 2.Two or more CR or CRIs Later recurrence; 3.Relapse for the first time after chemotherapy and no remission after at least one salvage treatment; 4.Recurrence after autologous or allogeneic hematopoietic stem cell transplantation; 3\. Bone marrow or peripheral blood flow cytometry showed positive CD19 and/or CD22 leukemia |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Tan Jie |
| Locations | Jinzhou, Hubei, China |
| Start date | 2024-05-24 |
| NCT ID | NCT06659653 |
| Official listing | https://clinicaltrials.gov/study/NCT06659653 |