Actively Recruiting
Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Led by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Updated on 2023-09-21
100
Participants Needed
2
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.
CONDITIONS
Official Title
Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to sign informed consent and able to follow study requirements
- Aged 18 to 70 years, male or female
- Diagnosed with CD20-positive B-cell Non-Hodgkin's Lymphoma including DLBCL, PMBCL, TFL, or HGBCL
- Previously received at least second-line adequate therapy or autologous hematopoietic stem cell transplantation
- In relapsed or refractory status at screening as defined by the study
- At least one measurable lesion according to Lugano Criteria
- ECOG performance status of 0 or 1
- Adequate bone marrow reserve with specific blood count thresholds
- Proper organ function with specified liver, kidney, and lung criteria
- Women of child-bearing potential must have negative pregnancy tests and agree to contraception; males must also agree to contraception
- Qualified T cell function
- Suitable vascular condition for apheresis with no contraindications
- At least 3 months since last CD20 monoclonal antibody treatment before U16 infusion
- Life expectancy longer than 3 months
You will not qualify if you...
- Having other malignant tumors except disease-free for over 3 years or carcinoma in-situ
- Lymphoma involvement in heart atrium or ventricle
- Use of immunosuppressants, hormones, or high-dose chemotherapy within 2 weeks before consent or planned use before apheresis (except local/inhaled corticosteroids)
- Positive tests for hepatitis B, hepatitis C, syphilis, HIV, EBV, or CMV beyond detection limits
- Active infections difficult to control
- Active primary or secondary central nervous system lymphoma or history of CNS diseases
- Significant recent cardiac events or heart disease
- Urgent clinical emergencies from lymphoma obstruction or compression
- Previous CAR-T cell therapy targeting CD20
- Primary immunodeficiency
- Known hypersensitivity to study drug ingredients
- Vaccination with live vaccine within 6 weeks before screening
- Pregnant or breastfeeding women
- Active autoimmune diseases or active graft-versus-host disease
- Allogeneic stem cell transplantation within 6 months
- Participation in another clinical trial within 30 days
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Not Yet Recruiting
2
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
X
Xiaoyan Lou, Dr.
CONTACT
L
Liqing Kang, Dr.
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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