Actively Recruiting
To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors
Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2025-06-18
100
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
Sponsors
H
Hebei Senlang Biotechnology Inc., Ltd.
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).
CONDITIONS
Official Title
To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with refractory or relapsed B-cell tumor, including B cell acute lymphocytic leukemia, indolent B cell lymphoma (CLL, FL, MZL), or aggressive B cell lymphoma (DLBCL, BL, MCL)
- Tumor cells test positive for CD19 and CD20 or CD22 by immunohistochemistry or flow cytometry
- Age between 18 and 70 years
- Estimated survival time greater than 3 months
- ECOG performance status score between 0 and 2
- At least one measurable tumor lesion according to RECIST Version 1.1
- Normal vital organ function: ejection fraction above 50%, no significant ECG abnormalities, oxygen saturation at least 92%, creatinine less than or equal to 1.5 times upper limit of normal, ALT and AST less than or equal to 5 times upper limit of normal, total bilirubin less than or equal to 3 times upper limit of normal
- Agreement to use contraception before and for six months after the study if planning pregnancy
- Signed informed consent by subject or guardian
You will not qualify if you...
- Other uncontrolled diseases including persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, arrhythmia, poorly controlled lung disease, or psychiatric conditions
- Presence of other malignant tumors
- Severe infections that cannot be controlled
- Positive hepatitis B surface antigen or hepatitis B core antibody with detectable HBV DNA, positive hepatitis C antibody with detectable HCV RNA, positive cytomegalovirus DNA, or positive Epstein-Barr virus DNA in blood
- Known positive tests for HIV or syphilis
- History of severe allergic reactions to biological products including antibiotics
- Relapse after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease
- Pregnancy or breastfeeding
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Any other condition that may increase risk or interfere with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
J
Jia Wei, PhD&MD
CONTACT
N
Na Kuang, PhD&MD
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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