Actively Recruiting
Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma
Led by Shanghai Exuma Biotechnology Ltd. · Updated on 2025-06-13
18
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
Sponsors
S
Shanghai Exuma Biotechnology Ltd.
Lead Sponsor
I
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.
CONDITIONS
Official Title
Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Able to understand the study and provide informed consent
- Willing to participate and comply with study procedures
- Diagnosed with CD19-positive large B-cell lymphoma based on WHO 2016 standards
- Have CD19 expression 50% by IHC or 70% by flow cytometry within 6 months or new testing done
- Previously treated with anthracycline-based therapy and rituximab or other CD20-targeted drugs
- Relapsed, progressive, or refractory large B-cell lymphoma after second-line therapy or after autologous stem cell transplant
- Have at least one measurable tumor lesion according to 2014 Lugano criteria
- Expected survival time greater than 12 weeks
- ECOG performance score of 0 or 1
- Able to establish intravenous access for blood collection with specified blood counts
- Adequate liver, kidney, heart, and lung function based on lab and clinical measures
- Participated in another interventional clinical study within 1 month and recovered from adverse events to severity 1
You will not qualify if you...
- History of allogeneic stem cell transplant, adoptive cell therapy, or gene-modified cell therapies
- Active or past central nervous system disease including epilepsy, stroke, dementia, or autoimmune CNS diseases
- Positive for hepatitis B or C, cytomegalovirus, HIV, or syphilis infections
- Unstable systemic diseases such as unstable angina, recent stroke, heart failure NYHA class III, active bleeding, severe arrhythmias
- Other malignant tumors except certain cured or localized cancers with >5 years disease-free survival
- Presence of gastric lymphoma, bulky disease, history of CD19+ leukemia, or active autoimmune diseases
- Uncontrolled active infections requiring treatment (except mild urinary or upper respiratory infections)
- Recent systemic steroid use or anticipated long-term steroid use during treatment (with exceptions)
- Anti-tumor treatment within 8 weeks before blood collection or local radiotherapy within 12 weeks
- Use of certain growth factors within 4 weeks before blood collection
- Use of specific chemotherapy or bone treatments within 3 to 6 months before blood collection
- Major surgery within 4 weeks before screening or incomplete recovery from invasive procedures
- Live vaccine received within 28 days before blood collection
- Pregnant or breastfeeding, or planning pregnancy within 2 years after treatment
- Investigator judgment deeming the subject unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China, 300020
Actively Recruiting
Research Team
S
Shihan Jie
CONTACT
L
Liujin Sai, master
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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