Actively Recruiting
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-12-28
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.
CONDITIONS
Official Title
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or guardian agrees to participate and signs informed consent
- Age 18 years or older, any gender
- Confirmed B-cell non-Hodgkin lymphoma diagnosis according to WHO 2017 criteria, including specific pathological types
- Previous adequate treatment with CD20 monoclonal antibody and anthracyclines unless contraindicated
- Relapsed or refractory disease as defined by recurrence, stable disease, no remission, or progression after prior treatments
- Positive CD19 expression by immunohistochemistry or flow cytometry
- ECOG performance status 0 to 1
- Expected survival of at least 12 weeks
- At least one measurable lesion meeting size criteria per 2014 Lugano standard
- Normal important organ functions including cardiac, renal, liver, and blood counts within defined limits
- No serious mental disorders
- Venous access available for cell collection and no contraindications
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception for 1 year post-infusion
- Male subjects with fertile partners must agree to use barrier contraception for 1 year post-infusion
You will not qualify if you...
- Active CNS lymphoma involvement or symptoms at screening
- Prior CAR-T or gene-modified cell therapy
- Previous allogeneic hematopoietic stem cell transplant
- Recent chemotherapy, targeted therapy, or radiation within specified washout periods
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus above normal ranges
- Certain serious heart conditions including NYHA class III/IV heart failure, recent heart attack, significant arrhythmias, or severe cardiomyopathy
- Active or uncontrolled infections within 1 week prior to screening
- Recent grade 2-4 acute graft-versus-host disease or moderate to severe chronic GVHD
- Recent stroke or seizure within 6 months
- Recent deep vein or artery embolism within 6 months
- Poorly controlled high blood pressure at screening
- Active or uncontrolled autoimmune diseases requiring systemic treatment
- Interstitial lung disease needing treatment
- Other active malignancies except specified treated cancers
- Recent live attenuated vaccine within 4 weeks
- Participation in other clinical trials within 4 weeks or 5 half-lives
- Pregnant or breastfeeding women, or those planning to have children within 1 year post-infusion
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Y
Yuqin Song, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here