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New treatment option for Acute Lymphocytic Leukemia
Official title A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors
ClinicalTrials.gov ID: NCT06783816
What this study is testing
What is chimeric antigen receptor gene modified T cells?
chimeric antigen receptor gene modified T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphocytic 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
- The is a multicenter, single arm, open label clinical study on the novel CAR-T combined expression of IL-15 in the treatment of malignant hematological tumors.Plan to recruit 45 subjects with malignant hematological tumors.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- I (or the authorized representative/legal guardian) agree and have signed an informed consent form, and am willing and capable of following the...
- Histopathological or flow cytometric diagnosis of CD19 and/or CD22, BCMA-positive hematological malignancies; -≥15 years old, ≤80 years old;
- If you meet one of the following three conditions, you can be included in the group:-Patients with recurrent or refractory hematologic malignancies...
- Estimated survival ≥12 weeks;
- Good heart, liver and kidney function:
You likely can't join if
- Have a New York Heart Association (NYHA) classification \> Class III heart failure or myocardial infarction, cardiac angioplasty or stenting...
- Have active GVHD, or need immunosuppressants;
- Other malignancies were present within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous...
- The presence of an active or uncontrolled infection requiring systemic treatment (except for mild genitourinary and upper respiratory tract...
- If HBSAg or HbCAb positive peripheral blood hepatitis B virus (HBV)DNA is higher than the lower limit of detection, it should be excluded. If...
- Participating in another clinical trial within 4 weeks prior to the signing of the informed consent, or the signing date of the informed consent is...
See the full eligibility criteria
- I (or the authorized representative/legal guardian) agree and have signed an informed consent form, and am willing and capable of following the planned visits, research treatments, laboratory tests, and other research...
- Histopathological or flow cytometric diagnosis of CD19 and/or CD22, BCMA-positive hematological malignancies; -≥15 years old, ≤80 years old;
- If you meet one of the following three conditions, you can be included in the group:-Patients with recurrent or refractory hematologic malignancies treated with one standard chemotherapy regimen and one salvage...
- Estimated survival ≥12 weeks;
- Good heart, liver and kidney function:
- Serum creatinine ≤ 1.5 mg/dL (1mg/dl=88.4umol/L); Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤ 1.5 mg/dl (1mg/dl=17.1umol/L):
- Cardiac ejection fraction ≥50%, cardiac ultrasound showed centropericardial effusion:
- Eastern Oncology Collaborative Group Activity Status Score (ECOG)0-3;
- Able to understand and voluntarily sign informed consent; If the subject is a child, the guardian will sign the informed consent. If the answer to any of the above is \"no\", the subject will not be allowed to...
- Have a New York Heart Association (NYHA) classification \> Class III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically prominent heart disease within one year...
- Have active GVHD, or need immunosuppressants;
- Other malignancies were present within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and breast ductal carcinoma in situ after radical...
- The presence of an active or uncontrolled infection requiring systemic treatment (except for mild genitourinary and upper respiratory tract infections) in the 7 days prior to screening;
- If HBSAg or HbCAb positive peripheral blood hepatitis B virus (HBV)DNA is higher than the lower limit of detection, it should be excluded. If hepatitis C virus (HCV) antibody positive, peripheral blood HCVRNA positive...
- Participating in another clinical trial within 4 weeks prior to the signing of the informed consent, or the signing date of the informed consent is still within 5 half-lives of the drug (whichever is longer) since the...
- A history of severe allergy to biological products;
- Systemic diseases that are considered unstable by the investigator: including but not -limited to severe liver, kidney, or metabolic diseases requiring medical treatment;
- Pregnant or lactating women, and female people who plan pregnancy within 2 years after cell transfusion or male people whose partner plans pregnancy within 2 years after cell transfusion;
- Conditions that the investigator believes may increase the risk to the subject or interfere with the test results.
The study team makes the final eligibility decision.
Where it's taking place
- Taiyuan, Shanxi, 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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiyuan, Shanxi, 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.