Actively Recruiting
Study of Cord Blood-derived CAR NK Cells Targeting CD19/CD70 in Refractory/Relapsed B-cell Non-Hodgkin Lymphoma
Led by Aibin Liang，MD，Ph.D. · Updated on 2023-05-06
48
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find the highest tolerable dose of dualCAR-NK19/70 (a type of cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.
CONDITIONS
Official Title
Study of Cord Blood-derived CAR NK Cells Targeting CD19/CD70 in Refractory/Relapsed B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years, male or female
- Histologically confirmed B-cell lymphomas including diffuse large B-cell lymphoma, transformed follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma, or other indolent B-cell NHL transforming types
- Relapsed or refractory disease after prior immunotherapy or chemotherapy as defined in protocol
- At least one measurable lesion with a longest diameter of 1.5 cm or more
- Estimated life expectancy greater than 12 weeks
- Confirmed diagnosis of CD19+ or CD70+ B-cell non-Hodgkin lymphoma
- ECOG performance status between 0 and 3
- Adequate organ function including liver enzymes, kidney function, bilirubin, cardiac ejection fraction, oxygen saturation, and blood counts as specified
- Previous autologous hematopoietic stem cell transplantation allowed
- At least 3 weeks since last systemic therapy or 2 weeks since targeted therapy before cell infusion
- Failed or relapsed after CAR-T therapy at 3 months assessment
- Willingness to use birth control if of childbearing potential and negative pregnancy test
- Undetectable COVID-19 viral load by PCR or nucleic acid testing on two tests
You will not qualify if you...
- Allergy to any components of the cell therapy product
- History of other malignant tumors
- Acute or severe chronic graft-versus-host disease after previous stem cell transplant or receiving anti-GVHD therapy
- Systemic gene therapy within prior 3 months
- Active systemic infections except minor urinary or throat infections
- Known infections including hepatitis B or C, syphilis, HIV, or other immunodeficiency diseases
- Severe heart failure (class III or IV)
- Ongoing toxicities from prior treatments above grade 1 except minor symptoms
- Active seizure disorders or other central nervous system diseases
- Evidence of central nervous system lymphoma on imaging
- Breastfeeding women
- Any conditions that increase risk or interfere with study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
Research Team
A
aibin Liang
CONTACT
P
Ping Li
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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