CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study

NCT07072494 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-KY-394-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Chimeric Antigen Receptor T-Cell Immunotherapy; CD19; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Leukemia-Free Survival(LFS)

  Relapse defined by ≥ BM blasts(ELN 2022)

  From Chimeric Antigen Receptor T-Cell infusion to relapse or death, assessed up to 12 months

Study Arms (1)

Consolidation therapy with CAR-T cells was performed after induced remission

EXPERIMENTAL

For autologous intravenous infusion only, the recommended dose is 0.5×108 CAR-T live cells, and the dose range is 0.25\~0.5×108 CAR-T live cells (±20%, i.e. 0.2-0.6×108 CAR-T live cells)

Drug: CD19 CAR-T cells injection

Interventions

CD19 CAR-T cells injection DRUG

Lymphodepleting pre-treatment will begin one week before the CAR-T cell infusion to reduce the burden of abnormal immune cells in the body, creating a favorable environment for the infused CAR-T cells. The suggested pre-treatment regimen is based on the FC regimen (Fludarabine + Cyclophosphamide).After the pre-treatment, patients will undergo CAR-T cell infusion, where the genetically modified T-cells are infused back into the patient's body.

Consolidation therapy with CAR-T cells was performed after induced remission

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has voluntarily agreed to participate, signed the informed consent form, and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
• The subject has been clinically diagnosed with newly diagnosed or refractory/relapsed B-cell acute lymphoblastic leukemia (B-ALL), including Burkitt lymphoma leukemia and blast-phase chronic myeloid leukemia, and has achieved complete remission (defined as \<5% bone marrow blasts, no peripheral blood blasts, and no extramedullary leukemia) after chemotherapy or immunotherapy, but is either ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT), lacks a suitable donor, or declines transplantation.
• Aged between 14 and 80 years (inclusive), male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• At the time of screening, leukemia cells in the bone marrow or peripheral blood must be confirmed as CD19-positive by flow cytometry at initial or relapse diagnosis.
• An expected survival of more than three months from the date of signing the informed consent form.
• Satisfactory liver, kidney, cardiac, and pulmonary function, defined as:
• Creatinine ≤2× upper limit of normal (ULN);
• Left ventricular ejection fraction (LVEF) ≥50%;
• Blood oxygen saturation \>92%;
• Total bilirubin ≤2× ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× ULN.
• Adequate venous access for cell collection and meeting the following hematologic criteria:
• Hemoglobin ≥80 g/L Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L Platelet count ≥75 × 10⁹/L If the above criteria are not met, the investigator may determine eligibility for mononuclear cell collection.
• Female subjects of childbearing potential must have a negative serum pregnancy test (women who have undergone surgical sterilization or have been postmenopausal for at least two years are considered non-fertile). Male and female subjects of reproductive potential must agree to use contraception during the study.

You may not qualify if:

• Presence of mixed-lineage leukemia or biphenotypic leukemia.
• Prior treatment with CAR-T cell therapy before screening or conditioning.
• Patients with bone marrow failure syndromes associated with genetic disorders, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.
• Any of the following viral infections:
• Hepatitis B virus (HBV) DNA detectable above the lower limit of quantification. Positive hepatitis C virus antibody (HCV-Ab). Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA detectable above the lower limit of quantification.
• Positive human immunodeficiency virus (HIV) antibody test.
• History of or current malignancy within the past five years (excluding patients with a low risk of recurrence after curative treatment and more than five years of follow-up, as determined by the investigator).
• Any of the following cardiac conditions:
• New York Heart Association (NYHA) Class III or IV congestive heart failure. Severe arrhythmia requiring treatment or clinically significant conduction abnormalities on ECG, including QTc interval ≥480 ms (QTcB = QT/√RR).
• Uncontrolled hypertension despite standard treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) or pulmonary hypertension.
• Unstable angina. Myocardial infarction, coronary artery bypass grafting, or stent placement within six months before cell infusion.
• Clinically significant valvular heart disease. Other cardiac diseases deemed inappropriate for study participation by the investigator.
• Uncontrolled epilepsy, a history of cerebrovascular ischemia/hemorrhage, cerebellar disease, or other active central nervous system (CNS) disorders.
• Clinically significant pericardial or pleural effusion at screening.
• History of deep vein thrombosis or pulmonary embolism within six months before screening.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (2)

Zhujiang Hospital

Guangzhou, Guangdong, 510200, China

RECRUITING

Zhujiang Hospital

Guangzhou, Guangdong, 510200, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Sanfang Tu, Doctor

CONTACT

86 13430200803; doctortutu@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: July 18, 2025
• Study Start: July 19, 2025
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): August 19, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (2)