Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a single center, open-label, dose-escalation/expansion clinical study to evaluate the safety and effectiveness of Fourth-Generation CAR-T, and determine the recommended dose of the CAR T-cells for patients with Multiple Myeloma,B-cell lymphoma and other hematologic malignancies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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⁃ Subjects must meet all of the following criteria to be enrolled:

⁃ 1\. Voluntarily participate in this clinical study and sign the informed consent form; 2. 18 to 75 years old (including cut-off value), Male and female;; 3. Expected survival of at least 3 months; 4.1 CD19-positive B lymphocyte-derived hematologic malignancies; 4.2 Multiple myeloma patients; 4.3 Non-B cell-derived hematologic malignancies patients with CD7 or other target molecules; 5. The clinical trial values during the screening period meet the following criteria:

• White blood cell count ≥ 3.0 × 10e9/L; Absolute neutrophil ≥ 1.0 × 10e9/L; Lymphocyte count ≥ 0.5 × 10e9/L. (The growth factor support is allowed, but growth factor must not have been received within 7 days prior to laboratory testing);

• Platelet count ≥ 50 × 10e9/L (No blood transfusion support within 7 days prior to laboratory tests.); Note: Patients with leukemia, multiple myeloma, and lymphoma are not subject to the above blood picture requirements;

• Biochemical indicators Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion); 6. Cardiac function: Subjects must have good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%; 7. Lung condition: Subjects are not serious infections such as severe pneumonia; 8. ECOG activity status score: 0-2 points; 9. Female subjects must use effective contraception (such as oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blockade, contraceptive patches, male partner sterilization) throughout the study period; Must have a negative serum or urine pregnancy test result at screening and throughout the study.

Locations
Other Locations
China
The Third Affiliated Hospital of Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Yan Yi, MD.
yiyan@smu.edu.cn
+86 13617493781
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Phase 1:Low dose group
Infusion of CAR T-cells by single dose of 0.5×10\^6 CAR-T cells/kg
Experimental: Phase 1: Medium dose group
Infusion of CAR T-cells by single dose of 1.5×10\^6 CAR-T cells/kg
Experimental: Phase 1: High dose group
Infusion of CAR T-cells by single dose of 5.0×10\^6 CAR-T cells/kg
Experimental: Phase 2a: RP2D
After all subjects in the Phase 1 dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 2a expansion study.
Sponsors
Leads: The Third Affiliated Hospital of Southern Medical University

This content was sourced from clinicaltrials.gov