Actively Recruiting
Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies
Led by The Third Affiliated Hospital of Southern Medical University · Updated on 2025-01-06
60
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years
- Expected survival of at least 3 months
- Diagnosed with CD19-positive B lymphocyte-derived hematologic malignancies, Multiple Myeloma, or non-B cell-derived hematologic malignancies with CD7 or other targets
- Blood counts during screening: white blood cells 23 3.0 x 10e9/L; neutrophils 23 1.0 x 10e9/L; lymphocytes 23 0.5 x 10e9/L (growth factor allowed but not within 7 days prior to tests)
- Platelet count 23 50 x 10e9/L (no transfusion within 7 days prior to tests); exceptions apply for leukemia, myeloma, lymphoma
- Liver function: total bilirubin 2.5 times upper normal limit (ULN); AST and ALT 2.5 ULN or 5 ULN if due to tumor invasion
- Heart function: left ventricular ejection fraction 23 55%
- No severe lung infections such as severe pneumonia
- ECOG performance status 0 to 2
- Female participants must use effective contraception throughout the study and have negative pregnancy tests at screening and during the study
You will not qualify if you...
- Previous CAR-T therapy targeting the same molecule
- Previous immunotargeted therapy targeting the same molecules
- Pregnant or breastfeeding women
- History of other cancers unless cured and no active disease for 3 or more years, or treated non-melanoma skin cancer with no current disease
- Severe mental disorders
- Active autoimmune disease needing immunotherapy
- Prior allogeneic hematopoietic stem cell transplant
- Significant heart disease including uncontrolled arrhythmias, heart failure grade 3 or 4, recent heart attack or bypass surgery within 6 months, history of serious ventricular arrhythmia or unexplained syncope
- Active infections including positive Hepatitis B, C, HIV, syphilis, active tuberculosis, or infections needing strong antibiotics
- Organ dysfunction such as elevated liver enzymes, bilirubin (except Gilbert's syndrome), high creatinine, or abnormal blood clotting without anticoagulants
- Participation in other clinical trials or gene therapy within past 3 months
- Uncontrolled diabetes (HbA1c >8%)
- History of severe allergies or contraindications to cyclophosphamide or fludarabine
- Low lymphocyte transfection or amplification during screening
- Investigator's judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
Research Team
Y
Yan Yi, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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