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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction
ClinicalTrials.gov ID: NCT06389305
What this study is testing
What is peripheral blood lymphocytes?
peripheral blood lymphocytes is an investigational medicine, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 39
You may be able to join if
- A patient must meet all of the following to be enrolled:
- A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer...
- Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.
- Age between 1 and 39 years old.
- No severe allergic constitution.
You likely can't join if
- A patient with at least one of the following conditions will be excluded:
- Received bendamustine treatment within the past 9 months;
- Intracranial hypertension or impaired consciousness in the brain;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- With other types of malignant tumors;
See the full eligibility criteria
- A patient must meet all of the following to be enrolled:
- A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer Network(NCCN) guidelines for the diagnosis of acute lymphoblastic...
- Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.
- Age between 1 and 39 years old.
- No severe allergic constitution.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy, as judged by the investigator, of at least 60 days.
- Patients with self-awareness between 8 and 39 years of age voluntarily sign an informed consent, and the legal representative (guardians) of child patients under 18 years of age voluntarily signs an informed consent.
- A patient with at least one of the following conditions will be excluded:
- Received bendamustine treatment within the past 9 months;
- Intracranial hypertension or impaired consciousness in the brain;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- With other types of malignant tumors;
- Disseminated intravascular coagulation;
- Serum creatinine and/or blood urea nitrogen ≥ 1.5 times the normal value;
- Suffering from sepsis or other uncontrollable infections;
- Uncontrollable diabetes;
- Severe mental disorders;
- Significant lesions in the brain as detected by head magnetic resonance imaging;
- Leukemic cells in the cerebrospinal fluid \>20 cells/μL;
- Peripheral blood leukemic cell proportion \>30%;
- Have undergone organ transplantation;
- Female patients (those with childbearing potential) are pregnant or lactating;
- Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.