Actively Recruiting
Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia
Led by Zhejiang University · Updated on 2026-02-24
16
Participants Needed
1
Research Sites
826 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
B
Bisheng (Beijing) Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of SYNCAR-100 in patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). Participants who have signed the informed consent form will undergo screening against the inclusion and exclusion criteria. Eligible participants will receive study drug administration once weekly for a total of four doses, followed by a 1-year safety and efficacy follow-up observation period. After the completion of the study, long-term follow-up may be required for participants to monitor their health and survival status until 15 years post-treatment, or until the occurrence of patient death, loss to follow-up, or withdrawal of consent.
CONDITIONS
Official Title
Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years (inclusive), any gender
- Karnofsky Performance Status score of 70 or higher
- Estimated life expectancy of at least 12 weeks
- Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood
- Confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) meeting one of the following: refractory B-ALL after 2 induction chemotherapy courses or salvage therapy failure; relapsed B-ALL within 12 months after first remission or after salvage therapy; relapse after autologous or allogeneic hematopoietic stem cell transplantation
- For Philadelphia chromosome-positive patients: failure or intolerance to at least 2 lines of tyrosine kinase inhibitor therapy, or resistance due to T315I mutation
- Bone marrow blasts and immature lymphocytes proportion greater than 5%
- No hematopoietic stem cell transplantation within 6 months before enrollment
- Adequate organ function including creatinine clearance above 60 mL/min, liver enzymes below specified limits, total bilirubin below specified limits, absolute lymphocyte count above 0.1 x 10^9/L, left ventricular ejection fraction above 50%, no significant pleural effusion, and oxygen saturation above 92% on room air
- For women of childbearing potential: non-lactating, negative pregnancy test at screening, and use of contraception during treatment and for 2 years after
- For men of childbearing potential: sperm donation prohibited during treatment and for 2 years after
- Ability to communicate effectively and willingness to comply with the study protocol and provide informed consent
You will not qualify if you...
- Isolated extramedullary leukemia or isolated extramedullary relapse
- Central nervous system involvement of leukemia at CNS2 stage
- History of other malignant tumors except cured non-melanoma skin cancer, carcinoma in situ of uterine cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other cancers with disease-free survival over 5 years
- Positive tests for HIV, HCV, hepatitis B surface antigen, positive HBcAb with HBV DNA, or TPPA
- Live or attenuated live vaccines within 4 weeks before enrollment
- Philadelphia chromosome-positive ALL with tyrosine kinase inhibitor therapy within 1 week before enrollment
- Prior CD19-targeted therapy, CAR-T cell therapy, or gene-edited T cell therapy
- Grade 2 or higher acute graft-versus-host disease requiring treatment, or extensive chronic graft-versus-host disease within 4 weeks prior to enrollment
- Comorbidities requiring systemic corticosteroid or immunosuppressive therapy during study, or recent allogeneic cellular therapy within 4 weeks
- Recent CNS-directed radiotherapy within 4 weeks before enrollment
- Unresolved acute toxicities from prior therapy (except hematologic toxicity and alopecia) not recovered to Grade 1 or lower
- Known life-threatening hypersensitivity or intolerance to study drug, or severe atopy history
- Active autoimmune diseases, excluding controllable hypothyroidism
- Major surgery requiring general anesthesia within 4 weeks before enrollment or anticipated during study without recovery
- Use of other investigational drugs within 28 days before enrollment
- History of unstable cardiovascular disease within 6 months prior to enrollment
- History of CNS disease or autoimmune disease involving CNS
- Uncontrolled active infection at screening
- Any other condition making the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, 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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