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This investigator-initiated, prospective, single-arm, open-label, single-center phase II study aims to evaluate the long-term survival benefit and safety of a commercial CD19 CAR-T product in newly diagnosed Philadelphia chromosome-positive or negative (Ph-positive or Ph-negative) B-cell ALL patients who achieve CR1 after induction chemotherapy. A total of 20 patients will be enrolled in the study. The primary endpoints include disease-free survival (DFS) and overall survival (OS) rates after a median follow-up of 2 years, minimal residual disease (MRD) negativity rate, and the proportion of patients undergoing subsequent hematopoietic stem cell transplantation (HSCT). The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after infusion will also be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological: Inaticabtagene autoleucel | Experimental | Administration of Inaticabtagene Autoleucel (CD19 CAR-T cells) in newly diagnosed B-ALL patients aged 14 to 70 years in their first complete remission (CR1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: single dose of Inaticabtagene autoleucel | Biological | Inaticabtagene autoleucel will be transfusioned intravenously at the recommended dose of 0.5×10^8 (ranging 0.2-0.6×10^8) viable CAR-T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year DFS rate (2yDFSR) | The proportion of patients who remain free from bone marrow disease relapse or death from any cause, assessed after a median follow-up of 2 years | Up to 2 years |
| 2-year OS rate (2yDFSR) | The proportion of patients who remain alive after a median follow-up of 2 years | Up to 2 years |
| DFS | The time from Inati-cel infusion to morphological relapse of B-ALL in the bone marrow, or death from any cause (whichever occurs first). | Up to 2 years |
| OS | The time from Inati-cel infusion to death from any cause | Till the end of the study, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patient underwent subsequent hematopoieticstem cell transplantation | Proportion of patient underwent subsequent hematopoieticstem cell transplantation | Till the end of the study, up to 5 years |
| MRD negativity rate |
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Inclusion Criteria:
Age ≥14 years and ≤70 years at screening, with no restrictions on gender.
ECOG performance status of 0 to 1.
Newly diagnosed B-ALL within 12 months and achieving CR1 after standard induction chemotherapy. This includes B-ALL patients with <5% bone marrow blasts, no blasts in peripheral blood, and no extramedullary leukemia. Diagnosis and chemotherapy regimen follow the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 Edition).
At the time of B-ALL diagnosis, leukemia cells in bone marrow or peripheral blood confirmed as CD19-positive via flow cytometry.
Adequate organ function meeting the following criteria:
No intent or eligibility for hematopoietic stem cell transplantation.
Meets the leukapheresis standards of the study center, with no contraindications for apheresis.
Women of childbearing potential must have a negative blood/urine pregnancy test during the Inati-cel screening period and before preconditioning (results within three days prior to preconditioning). All male and female patients of childbearing potential must agree to use effective contraception throughout the study and for at least two years following study treatment. A female is considered of childbearing potential if biologically capable of having children and engaging in regular sexual activity. Women are considered not of childbearing potential if they meet at least one of the following:
Exclusion Criteria:
Diagnosis of Burkitt lymphoma/leukemia, heterozygous or double-hit leukemia, or chronic myeloid leukemia in blast crisis.
Presence of ≥5% blasts in the bone marrow or peripheral blood, or evidence of extramedullary leukemia before screening or preconditioning.
Prior treatment with CAR-T cell therapy or hematopoietic stem cell transplantation (HSCT) before screening or preconditioning.
Genetic syndromes associated with bone marrow failure, including Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known bone marrow failure syndromes.
Presence of any of the following conditions:
Diagnosis of other malignancies within the past 5 years, unless the tumor was curatively treated, with a follow-up period exceeding 5 years, and a low risk of recurrence as assessed by the investigator.
Presence of any of the following cardiac conditions:
History of epilepsy, ischemic or hemorrhagic stroke, cerebellar disease, or other active central nervous system disorders.
Clinically significant pleural effusion at the time of screening.
History of deep vein thrombosis or pulmonary embolism within the past 6 months.
Known hypersensitivity to any components of the investigational products used in the trial.
Receipt of live vaccines within 6 weeks prior to screening.
Presence of active infections at the time of screening.
An expected survival of less than 3 months.
Participation in other interventional clinical studies involving investigational drugs:
Any other conditions deemed unsuitable for study participation by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Jin | Contact | 0571-87236898 | jiej0503@163.com |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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|
the proportion of patients achieved undetectable levels of minimal residual disease at Day 28、Month 2,3,6 by flow cytometry and at Day 28 by NGS
| 6 months |
| Maximum observed concentration(Cmax) | 6 months |
| Time of Cmax (Tmax) | 6 months |
| Partial area under the concentration-time curve (from time zero to 28days after dosing , AUC 0-28 day) | 6 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |