Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Conditions
Interventions
CTA30X Cell Injection:CTA30X Cell Injection
Sponsors
The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
3 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged = 3 and < 70 years old, regardless of gender; 2. Patients with CD19 + and / or CD22 + B-ALL confirmed by flow cytometry according to NCCN clinical practice guidelines for acute lymphoblastic leukemia (2020. V2); 3. Subjects meeting the diagnosis of relapsed / refractory B-ALL, including any of the following conditions: (1) No CR was obtained after 2 cycles of standard chemotherapy; (2) CR was induced for the first time, but the duration of Cr was less than or equal to 12 months; (3) Relapsed / refractory B-ALL after the first or multiple salvage treatment; (4) Recurrence after hematopoietic stem cell transplantation, including hematological recurrence and minimal residual disease (MRD) positive; 4. Subjects whose estimated survival time is more than 3 months; 5. Subjects with ECoG score of 0-2.
Exclusion criteria
Exclusion criteria: 1. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome; 2. Uncontrolled active CNSL; 3. History of hypersensitivity to any component of cell product; 4. Pregnant or lactating women; 5. History of alcoholism, drug abuse or mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs);Incidence of treatment emergent adverse events (TEAEs); | — |
Countries
China
Contacts
Public ContactXiaoyu Zhu
The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)
Outcome results
None listed