NCT04325841CompletedPhase 2
Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children
Phase II Study of Autologous Murine Anti-CD19 Chimeric Antigen Receptor T Cells Treating Refractory or Relapsed B Acute Lymphoblastic Leukemia Children
Source: ClinicalTrials.gov · Last updated 18 May 2025
Brief summary (registry, in English)
The investigators will conduct a phase II clinical trial of autologous murine anti-CD19 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia children in Beijing Boren Hospital. The study will be approved by the institutional review board of Beijing Boren Hospital, and informed consent will be obtained in accordance with the Declaration of Helsinki. All these participants will be matched the diagnostic criteria for (r/r) B-ALL according to the WHO classification and complete morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis and leukemia fusion gene screening by multiplex nested reverse transcriptase-polymerase chain reaction (PCR). Participants will be eligible if they are heavily treated B-ALL who failed from re-induction chemotherapy after relapse or continued MRD+ for more than three months, and had positive CD19 expression on leukemia blasts by FCM (\>95% CD19). After CAR T-cell infusion, clinical outcomes including overall survival (OS), Disease-free survival (DFS), adverse effects and relapse will be evaluated.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- First submitted
- 26 Mar 2020
- Start date
- 24 Mar 2022
- Primary completion date
- 3 Apr 2024
- Lead sponsor
- Beijing Boren Hospital
- NCT number
- NCT04325841
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 2
- From 24 Mar 2022 to the primary completion date, 3 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Sepsis or other uncontrolled infection;
- Uncontrolled diabetes mellitus;
- Severe psychological disorder;
- Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
Lab values
- Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range;
- More than 20 counts/ul leukemic cells in cerebrospinal fluid;
Other
- Diffuse intravascular coagulation;
- Obvious cranial lesions with cranial MRI;
- More than 30% leukemic cells in the blood;
- Stage III WHO/ECOG score;
- Organ recipients;
- Pregnant or breastfeeding;
Who the study is looking for
- Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference. Extramedullary diseases (EMDs) were confirmed CD19+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography. The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD19 expression on leukemia blasts by FCM (\>95% CD19 positive);
- Age from 0 to 18 years old;
- Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form;
Age in the registry: 0 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Boren Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.