New CAR-T therapy with IL-15 for treating blood cancers

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

This study is testing a new CAR-T therapy combined with IL-15 to see if it can help people with blood cancers like leukemia and multiple myeloma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Drugs / interventions: chemotherapy, CAR-T
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT06783816 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a novel CAR-T therapy that co-expresses IL-15 for patients with malignant hematological tumors, including acute lymphocytic leukemia and relapsed refractory multiple myeloma. It is a multicenter, single-arm, open-label study aiming to recruit 45 subjects. The primary focus is on assessing the safety and efficacy of this innovative treatment, while secondary objectives include investigating the in vivo survival time and the activation and proliferation of the CAR-T cells. Participants will receive chimeric antigen receptor gene modified T cells as the intervention.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 15 to 80 with CD19 and/or CD22, BCMA-positive hematological malignancies who have undergone prior chemotherapy and have a life expectancy of at least 12 weeks.

Not a fit: Patients with hematological malignancies that do not express CD19, CD22, or BCMA, or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat blood cancers.

How similar studies have performed: While CAR-T therapies have shown success in treating hematological malignancies, the specific combination with IL-15 is a novel approach that has not been extensively tested.

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.

Where this trial is running

Taiyuan, Shanxi

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Jia Wei

Conditions Acute Lymphocytic Leukemia; Lymphoma,Non-Hodgkin; Relapsed Refractory Multiple Myeloma; CAR-T; IL-15; malignant hematological tumors