Actively Recruiting
Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Led by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Updated on 2026-01-28
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.
CONDITIONS
Official Title
Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with relapsed or refractory diffuse large B-cell lymphoma
- Failure to achieve complete remission after 6 cycles or partial remission after 3 cycles of first-line therapy, or relapse within 12 months after complete remission
- Relapsed or refractory after systemic treatment without plans for transplant or unable to meet transplant criteria after second-line therapy
- No complete remission after at least two courses of second-line treatment including autologous stem cell transplantation
- Expected survival of 3 months or more
- At least one measurable lesion according to lymphoma response criteria
- CD19 positive expression detected on tumor cells
- Eastern Cooperative Oncology Group (ECOG) score of 2 or less
- Adequate organ function including renal, hepatic, pulmonary, cardiac, and bone marrow function
- Stable hemodynamics and left ventricular ejection fraction of 45% or higher
- Adequate bone marrow reserve without blood transfusion
- Investigator judgment that general condition and biochemical values are sufficient for lymphodepletion and CAR-T therapy
You will not qualify if you...
- Pregnant or breastfeeding women, or planning pregnancy within 6 months
- Infectious diseases including HIV and active tuberculosis
- Active infections such as hepatitis B or hepatitis C
- Abnormal vital signs or refusal to undergo examinations
- Psychiatric or psychological disorders preventing treatment or assessment
- History of severe or known hypersensitivity to IL-2
- Severe systemic or local infection requiring antimicrobial therapy
- Significant dysfunction of vital organs or other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Suzhou Hongci Hematology Hospital
Suzhou, China
Actively Recruiting
Research Team
X
Xiao Ma
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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