NCT06783816 A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors
| NCT ID | NCT06783816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanxi Bethune Hospital |
| Condition | Acute Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2023-12-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 procedures; * 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 regimen;-Minimal residual lesions persist after treatment with one standard chemotherapy regimen and one salvage regimen;-Patients with recurrence after hematopoietic stem cell transplantation; * 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 participate in this study. Exclusion Criteria: * 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 prior to signing the consent form, or have a QTC interval \>480ms at the time of screening (QTC interval is calculated using the Fridericia formula); * 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 resection of local prostate cancer; * 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 should be excluded; (HIV) antibody-positive; -Cytomegalovirus (CMV)DNA test positive for human immunodeficiency virus; Those who test positive for Treponema pallidum specific antibody (TPPA) should be excluded; * 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 last drug used in the last clinical trial; * 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 subjects who plan pregnancy within 2 years after cell transfusion or male subjects 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06783816 clinical trial?
This trial is open to participants of all sexes, studying Acute Lymphocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06783816 currently recruiting?
Yes, NCT06783816 is actively recruiting participants. Contact the research team at ngc2237fh@163.com for enrollment information.
Where is the NCT06783816 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT06783816 clinical trial?
NCT06783816 is sponsored by Shanxi Bethune Hospital. The trial plans to enroll 45 participants.
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