Actively Recruiting
An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
Led by Peking University People's Hospital · Updated on 2026-01-15
18
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
H
Hebei Senlang Biotechnology Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma
CONDITIONS
Official Title
An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- Male or female aged 18 years or older at consent
- Expected life expectancy of at least 12 weeks
- ECOG performance status between 0 and 2 at consent
- Diagnosis of relapsed or refractory aggressive B-cell lymphoma
- Prior treatment with anthracycline chemotherapy and rituximab or other CD20 agents
- Relapse or progression after at least two prior therapies or autologous stem cell transplant
- Presence of measurable lymphoma lesions per Lugano criteria
- Lymphoma lesions confirmed by biopsy expressing CD19 and/or CD20
- Adequate major organ function
- Use of contraception
You will not qualify if you...
- Lymphoma involving only the central nervous system except secondary CNS lymphoma
- History of central nervous system disorders
- Autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to consent
- Uncontrolled active infection at consent or within 2 weeks before leukapheresis requiring treatment
- Evidence of active infections including HBV, HCV, HIV, CMV, EBV, or syphilis
- Clinically significant cardiovascular disease
- Known allergy to components of the investigational products
- Receipt of investigational or systemic antitumor therapy within 5 half-lives before leukapheresis
- Need for systemic corticosteroids or immunosuppressive agents within 2 weeks before consent, leukapheresis, or during study
- Major surgery within 4 weeks prior to consent or planned during study
- History of other cancers within 5 years except treated carcinoma in situ of cervix or localized skin cancers
- Live attenuated vaccine within 4 weeks before consent or planned during screening
- Any condition affecting compliance or suitability as judged by the investigator
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
X
Xiaodong Mo, PhD
CONTACT
M
Meng Lv, PhD
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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