Actively Recruiting
Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma
Led by Xuzhou Medical University · Updated on 2023-11-15
20
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
X
Xuzhou Medical University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Single-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase
CONDITIONS
Official Title
Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Expected survival of more than 12 weeks
- Diagnosed with multiple myeloma by physical, pathological, laboratory, and imaging examinations
- Patients with refractory multiple myeloma
- Patients with recurrence of multiple myeloma
- Liver enzymes ALT and AST less than 3 times normal; bilirubin less than 2.0 mg/dl
- Quality of survival score (KPS) greater than 50%
- No serious heart, liver, kidney, or other diseases
- Recurrence or no remission after hematopoietic stem cell transplantation or cellular immunotherapy
- Not suitable for stem cell transplantation or have declined transplantation
- Able to provide blood intravenously without contraindications to leukapheresis
- Understands and voluntarily signs informed consent
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy within six months
- Infectious diseases such as HIV or active tuberculosis
- Active hepatitis B or hepatitis C infection
- Less than 10% transfection of targeted lymphocytes or less than 5-fold amplification under CD3/CD28 stimulation
- Abnormal vital signs preventing cooperation with examinations
- Mental illness preventing cooperation with treatment and evaluation
- History of severe allergies, especially to IL-2
- Systemic or severe local infection requiring anti-infective treatment
- Severe autoimmune disease
- Other reasons deemed by the doctor for exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kailin Xu
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
Research Team
K
Kailin Xu MD, PD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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