Actively Recruiting
CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
Led by Shanghai Ming Ju Biotechnology Co., Ltd. · Updated on 2024-08-21
12
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
CONDITIONS
Official Title
CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Signed informed consent
- Histologically confirmed Large B-cell Lymphoma
- Previously treated with anthracyclines and rituximab (or other CD20-targeted antibodies) and relapsed or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation
- Have accessible PET-positive lesion and measurable CT-positive lesion based on Lugano Classification
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Adequate vascular access for leukapheresis
- If previously treated with CD19-targeted therapy, lymphoma lesions must still express CD19
- Women of childbearing potential must agree to use highly effective contraception for 1 year after last dose of Relma-cel
- Males with partners of childbearing potential must agree to use effective barrier contraception for 1 year after last dose of Relma-cel
You will not qualify if you...
- Primary CNS lymphoma
- History of another primary malignancy not in remission for at least 2 years
- Active infection with HBV, HCV, HIV, or syphilis at screening
- Active deep venous thrombosis or pulmonary embolism requiring anticoagulation within 3 months prior to consent
- Uncontrolled systemic fungal, bacterial, viral, or other infection
- Presence of acute or chronic graft-versus-host disease (GVHD)
- History of serious cardiovascular disease or clinically relevant CNS pathology
- Pregnant or nursing women
- Recent use of chemotherapy, corticosteroids, experimental agents, GVHD therapies, radiation, allo-HSCT, or other lymphoma therapies without required washout period before leukapheresis
- Uncontrolled conditions or inability/unwillingness to follow study procedures
- Prior treatment with CAR T-cell or other genetically modified T-cell therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
R
Relma-cel Medical
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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