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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Contact Information
Primary
JIA WEI
ngc2237fh@163.com
CHN13986102084
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 45
Treatments
Experimental: Group1
In patients with acute B-lymphoblastic leukemia, the dose was 0.5-1.5×10\^6 CAR-positive T cells /kg body weight. The usual dose of B-cell non-Hodgkin lymphoma was 0.5-2.0 ×10\^6/kg CAR-positive T cells. The initial dose of r/r multiple myeloma is 1x10\^6/kg, and the dose of 3x10\^6/kg and 5x10\^6/kg are generally proposed to increase successively.
Sponsors
Leads: Shanxi Bethune Hospital

This content was sourced from clinicaltrials.gov

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