Actively Recruiting
Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL
Led by Peking University People's Hospital · Updated on 2026-03-30
50
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
H
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL
CONDITIONS
Official Title
Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or guardian understands the study and signs informed consent
- Male or female aged 12 to 65 years
- Expected survival of at least 12 weeks
- ECOG performance status 0-2
- Diagnosed with relapsed or refractory B-ALL with >5% bone marrow blasts, detectable leukemic cells in cerebrospinal fluid, or measurable extramedullary lesions
- Tumor cells positive for CD19 or CD22 by flow cytometry or pathology
- For Phase II, must have failed prior immunotherapies including blinatumomab, inotuzumab ozogamicin, or single-target CAR-T therapy
- Adequate liver function: AST and ALT 3 times upper limit of normal, total bilirubin 2 times upper limit of normal
- Adequate renal function: serum creatinine clearance 60 mL/min for adults or specified serum creatinine levels for children
- Blood oxygen saturation >92% on room air
- Fertile participants must agree to use effective contraception during study and for 2 years after
- Negative pregnancy test for women of childbearing potential at screening
You will not qualify if you...
- History of central nervous system diseases including epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy
- History of autoimmune diseases requiring systemic immunosuppressive therapy within past 2 years
- Active uncontrolled infection requiring treatment within 4 weeks prior to apheresis
- Positive for hepatitis B (with detectable HBV DNA), hepatitis C (with detectable HCV RNA), HIV, CMV DNA, EBV DNA, or syphilis
- Significant cardiovascular diseases including prolonged QTc, heart failure NYHA Class II or higher, recent unstable angina or heart attack, low ejection fraction, uncontrolled hypertension, or serious arrhythmias
- Severe allergy to study drug components
- Recent investigational or systemic antitumor therapy within 4 weeks
- Extensive radiotherapy within 4 weeks prior to consent except limited palliative radiotherapy
- Unresolved toxicity from prior therapy greater than Grade 1 except hair loss or pigmentation
- Systemic corticosteroids or immunosuppressive therapy above specified doses within 3 days prior to apheresis or during study (with limited exceptions)
- Major surgery within 4 weeks prior to consent or planned during study
- Active tuberculosis within 1 year prior to consent
- Other primary malignancies within 5 years except certain treated skin or cervical cancers
- Live or inactivated vaccines within 4 weeks prior to consent or planned during screening
- Any condition that may affect study adherence or suitability
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
M
MENG LV, MD, 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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