Actively Recruiting
To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL
Led by Hrain Biotechnology Co., Ltd. · Updated on 2023-09-21
18
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
H
Hrain Biotechnology Co., Ltd.
Lead Sponsor
S
Shanghai Changzheng Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.
CONDITIONS
Official Title
To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who understand and sign informed consent and are willing to complete all trial procedures
- Age 18 years or older, any gender
- Expected survival longer than 12 weeks
- Documented diagnosis of multiple myeloma or plasma cell leukemia according to accepted criteria
- Evidence of disease activity by specific laboratory measures such as serum or urine M protein levels or clonal plasma cells
- Relapsed or refractory patients who have had at least 3 prior treatment regimens including one proteasome inhibitor and one immunomodulatory drug
- Disease progression within 60 days of last treatment or lack of minimal response
- Adequate liver, kidney, and heart function including creatinine clearance ≥ 30 mL/min and left ventricular ejection fraction > 50%
- Peripheral oxygen saturation > 95%
- Blood counts with hemoglobin ≥ 60 g/L, neutrophils ≥ 1.0 x 10^9/L, and platelets ≥ 30 x 10^9/L
- Ability to complete the trial as judged by investigators
You will not qualify if you...
- Other uncontrolled cancers
- Positive tests for active hepatitis B, hepatitis C, HIV, or syphilis infections
- Unstable systemic diseases such as unstable angina, recent stroke, recent myocardial infarction, severe heart failure, or serious arrhythmias
- Pregnant or breastfeeding women or those planning pregnancy within 1 year after treatment
- Previous CAR-NK or gene therapy treatments
- Inability or unwillingness to comply with study procedures or give informed consent
- Severe allergic reactions to any study drugs
- Active or uncontrolled infections requiring systemic therapy within 14 days prior to enrollment
- Organ damage from autoimmune diseases within past two years or use of systemic immunosuppressive drugs
- Symptoms affecting the central nervous system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
X
Xuedong Sun, Doctor
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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