Safety and Effectiveness of Fourth-Generation CAR-T Cell Therapy
for Blood Cancers Including Multiple Myeloma and B-cell Lymphoma
A Dose-Escalation and Expansion Clinical Study
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
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
Published Results
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Fourth-Generation CAR-T cell therapy in treating patients with Multiple Myeloma, B-cell lymphoma, and other blood-related cancers. This single-center, open-label, phase 1 study aims to determine the recommended dose of CAR T-cells while monitoring for dose-limiting toxicities and treatment responses.
Before receiving the CAR T-cell infusion, participants undergo lymphodepleting therapy with fludarabine and cyclophosphamide. The CAR T-cell therapy targets specific molecules like BCMA, CD19, or CD7 on cancer cells. Researchers will escalate doses to find the maximum tolerated dose and recommended phase 2 dose. Participants will be closely observed for side effects and treatment effects during and after therapy.
During the study, participants will be monitored for adverse events for at least two years after infusion. The study will measure dose-limiting toxicities within 30 days, and assess objective response rates over an average of two years. Clinical assessments include blood tests, cardiac and lung evaluations, and pregnancy testing for women. The total study duration includes initial treatment and long-term follow-up to evaluate safety and efficacy.
CONDITIONS
Official Title
Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies
Who Can Participate
Age: 18Years - 75Years
All Genders
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
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
1
2
3
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
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Research Team
Y
Yan Yi, MD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
Frequently Asked Questions
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