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Hema-NeoTIL01 Cell Infusion Therapy in Relapsed/Refractory Acute Leukemia

ConditionsLeukemia, Myeloid, AcuteB-cell Acute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of autologous tumor-specific T cells, known as Hema-NeoTIL0 in treating relapsed/refractory B-ALL/AML.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and <70 years old, gender not specified;

Diagnosed with B-ALL or AML according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version);

Meet the diagnosis of relapsed/refractory leukemia, excluding isolated extramedullary relapse; For relapsed or refractory ALL, including any of the following situations: a) Relapse: Peripheral blood or bone marrow recurrence of primitive cells >5% or extramedullary lesions appear again after complete remission; b) Refractory: Primary refractory patients who fail to achieve complete remission after standard induction chemotherapy; Or meet the diagnosis of relapsed or refractory AML, including any of the following situations: a) Relapse: Recurrence of primitive cells >5% in bone marrow after complete remission (except for reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary infiltration of leukemia cells; b) Refractory: Patients who have failed two cycles of standard treatment; those who relapse within 12 months after CR after consolidation therapy; those who relapse after 12 months and are ineffective after conventional chemotherapy; those with two or more relapses; those with persistent extramedullary leukemia;

Patients who have previously received ineffective/relapsed CAR-T cell therapy may be included in this study, provided that the efficacy evaluation of CAR-T therapy has been completed and evaluated as NR, or relapse after remission of CAR-T therapy;

Disqualifiers

Patients with a history of severe central nervous system diseases, such as uncontrolled seizures, stroke, severe brain injury resulting in aphasia, paralysis, dementia, Parkinson's disease, psychiatric disorders, etc.;

New York Heart Association (NYHA) functional class III or IV heart failure;

Any unstable diseases occurring within 6 months before screening (including but not limited to): unstable angina, ischemic or cerebrovascular accidents, myocardial infarction, severe arrhythmias requiring drug treatment (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), cardiac catheterization or coronary artery stenting, or coronary artery bypass surgery, thrombotic or embolic events.

Presence of disseminated intravascular coagulation;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hema-NeoTIL01

    Biological/Vaccine

    Patients will receive intravenous infusion of Hema-NeoTIL01, which is a highly specific tumor infiltrating lymphocyte (TIL) product derived from patients' bone marrow or peripheral blood, expanded ex vivo through antigen presentation.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Hema-NeoTIL01 treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CR/CRi, MRD-negative CR

Complete remission (CR) is defined as the presence of less than 5% bone marrow blasts in an aspirate containing spicules, accompanied by independence from transfusions. CR with incomplete hematologic recovery (CRi) is defined as the presence of less than 5% bone marrow blasts, with either an absolute neutrophil count (ANC) of less than 1×10\^9/L or a platelet count of less than 100×10\^9/L, while remaining transfusion-independent but exhibiting persistent cytopenia. Minimal residual disease (MRD)-negative CR is defined as a leukemic cell count below the sensitivity threshold of 1×10\^-4 (0.01%) of bone marrow mononuclear cells (MNCs), as measured by multiparameter flow cytometry.

Time frame
Within 28 days after the first dose

Secondary outcomes

1

RFS

Relapse-free survival (RFS) is defined as the interval from the date of achieving CR to the first occurrence of leukemia relapse, death, or the date of the last follow-up.

Time frame
2 years
2

OS

Overall survival (OS) is defined as the duration from the time of enrollment to death from any cause.

Time frame
2 years
3

Adverse events

The number of adverse events are evaluated with CTCAE V5.0.

Time frame
Within 28 days after the first dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: