B-Cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT07429461
Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia
A Early Phase 1 study testing SYNCAR-100 Injection in people with B-Cell Acute Lymphoblastic Leukemia, run by Zhejiang University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-Cell Acute Lymphoblastic Leukemia
- What is being tested?
- SYNCAR-100 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 31 Dec 2041
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Aged 18 to 75 years (inclusive), of any gender.
- 2.Karnofsky Performance Status score ≥ 70.
- 3.Estimated life expectancy ≥ 12 weeks.
- 4.Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood.
- 5.Confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) by bone marrow examination, and meeting one of the following criteria:
- ① Refractory B-ALL: Failure to achieve complete remission (CR) after 2 courses of standard induction chemotherapy, or failure to achieve CR after first-line/multiline salvage chemotherapy.
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- ② Relapsed B-ALL: Relapse within 12 months after the first remission, or relapse after first-line/multiline salvage chemotherapy.
- ③Relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT).
- ④ For Philadelphia chromosome-positive (Ph+) patients: At least 2 lines of tyrosine kinase inhibitor (TKI) therapy have failed, or the patient is intolerant to TKI therapy, or the patient harbors the T315I mutation and is resistant to TKIs.
- 6.Proportion of blasts and immature lymphocytes in bone marrow > 5% confirmed by bone marrow morphologic examination.
- 7.No prior hematopoietic stem cell transplantation (HSCT) within 6 months before enrollment.
- 8.Adequate organ function reserve, as defined by all of the following:
- ① Creatinine clearance (calculated by the Cockcroft-Gault formula) > 60 mL/min: Male: Creatinine Clearance = [(140 - Age) × Body Weight (kg)] / [0.818 × Serum Creatinine (μmol/L)] Female: Creatinine Clearance = [(140 - Age) × Body Weight (kg) × 0.85] / [0.818 × Serum Creatinine (μmol/L)]
- ② Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the upper limit of normal (ULN) ; for patients with hepatic metastasis, AST and ALT ≤ 5 times the upper limit of normal (ULN) .
- ③Serum total bilirubin < 1.5 times the upper limit of normal (ULN) ; for patients with Gilbert's syndrome, total bilirubin ≤ 3 times the upper limit of normal (ULN) .
- ④ Absolute lymphocyte count (ALC) ≥ 0.1 × 10^9/L.
- ⑤Left ventricular ejection fraction (LVEF) > 50% confirmed by echocardiography, with no clinically significant pericardial effusion on echocardiography.
- ⑥ No clinically significant pleural effusion.
- ⑦ Baseline peripheral oxygen saturation (measured at the fingertip) > 92% while breathing room air.
- 9.For women of childbearing potential: Non-lactating; negative result of highly sensitive serum or urine pregnancy test during screening. All women of childbearing potential must use medically accepted contraceptive methods (e.g., intrauterine device, oral contraceptives) throughout the treatment period and for 2 years after the first treatment. For males of childbearing potential: Sperm donation is prohibited during the same period.
- 10.Ability to communicate effectively with investigators; willingness and ability to comply with the study protocol, complete all study-related procedures as required, and provide written informed consent (signed voluntarily by the patient or their legal guardian).
Who cannot join
- 1.Isolated extramedullary leukemia or isolated extramedullary relapse.
- 2.Central nervous system (CNS) involvement of leukemia at CNS2 stage.
- 3.A history of other malignant tumors, except for the following: cured non-melanoma skin cancer, carcinoma in situ of the uterine cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other malignant tumors with disease-free survival for more than 5 years.
- 4.Positive test results for any of the following infectious diseases: HIV; HCV; HBsAg; positive HBcAb with concurrent positive HBV DNA copy number; TPPA.
- 5.Administration of live or attenuated live vaccines within 4 weeks prior to enrollment.
- 6.Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with tyrosine kinase inhibitor (TKI) therapy within 1 week prior to enrollment.
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- 7.Prior receipt of CD19-targeted therapy, CAR-T cell therapy, or other gene-edited T cell therapy.
- 8.Grade ≥2 acute graft-versus-host disease (GVHD) (per Glucksberg criteria) requiring treatment, or extensive chronic GVHD (per Seattle criteria) within 4 weeks prior to enrollment; or patients judged by the investigator to potentially require anti-GVHD therapy during the study period.
- 9.Comorbidities judged by the investigator to require systemic corticosteroid therapy or other immunosuppressive therapy during the study period; or receipt of allogeneic cellular therapy (e.g., donor lymphocyte infusion [DLI]) within 4 weeks prior to enrollment.
- 10.Receipt of CNS-directed radiotherapy within 4 weeks prior to enrollment.
- 11.Unresolved acute toxicities from prior therapy (excluding hematologic toxicities and alopecia) that have not recovered to Grade 1 or lower.
- 12.Known life-threatening hypersensitivity or other intolerance to the study drug, or a history of severe atopy.
- 13.Active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.), excluding hypothyroidism that is controllable solely with hormone replacement therapy.
- 14.Receipt of major surgery requiring general anesthesia within 4 weeks prior to enrollment; or failure to recover and achieve clinical stability from prior surgical treatment; or anticipated major surgery requiring general anesthesia during the study period.
- 15.Use of other investigational drugs within 28 days prior to enrollment.
- 16.A history of any unstable cardiovascular disease within 6 months prior to enrollment, including but not limited to unstable angina pectoris, myocardial infarction, heart failure (New York Heart Association [NYHA] Class ≥III), severe cardiac arrhythmias requiring pharmacologic treatment; or receipt of percutaneous transluminal coronary angioplasty, coronary stenting, or coronary artery bypass grafting within 6 months prior to enrollment.
- 17.A history of central nervous system (CNS) disease or disorders (e.g., seizure disorders, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease) or any autoimmune disease involving the CNS.
- 18.Uncontrolled active infection at screening (e.g., sepsis, bacteremia, fungemia, viremia).
- 19.Any other condition judged by the investigator to make the patient unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, MD, 13605714822, hehuangyu@126.com
About this study
Official title: Early Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SYNCAR-100 in the Treatment of CD19-Positive Relapsed or Refractory Acute B-Lymphoblastic Leukemia (R/R B-ALL)
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.
Read the detailed description
Acute lymphoblastic leukemia (ALL) is a hematologic malignancy characterized by the clonal abnormal proliferation and accumulation of lymphoid precursor cells (B or T lineage) in the bone marrow, peripheral blood and other organs. B-cell acute lymphoblastic leukemia (B-ALL) is the more common subtype, accounting for approximately 80% of all cases. For adult patients with relapsed or refractory B-ALL, only about 5-30% can achieve complete remission (CR) following salvage therapy. In addition, among patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), approximately 35% experience disease relapse, with a median overall survival of no more than 6 months; the estimated 1-year, 2-year and 5-year overall survival rates are about 30%, 15% and 10%, respectively. Relapse after allo-HSCT remains a major challenge in the treatment of hematologic malignancies, and there is no effective therapeutic approach recommended by clinical practice guidelines or consensus statements. Therapies such as retransplantation, donor lymphocyte infusion (DLI) and blinatumomab yield overall suboptimal efficacy, creating an urgent unmet medical need for novel and effective therapeutic strategies.
SYNCAR-100 is a next-generation nucleic acid drug candidate developed by Bisheng (Beijing) Biotechnology Co., Ltd. based on circular RNA (circRNA) technology. The safety of SYNCAR-100 will be evaluated by assessing indicators including dose-limiting toxicities (DLT), vital sign measurements, physical examinations, laboratory tests, 12-lead electrocardiography (ECG), peripheral blood B-cell and T-cell levels, and adverse events (AE). The efficacy of SYNCAR-100 in patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) will be evaluated by measuring endpoints including the overall response rate (ORR) within 12 weeks, the rate of complete remission with minimal residual disease (MRD)-negativity, duration of response (DOR), progression-free survival (PFS), as well as the ORR within 48 weeks, the rate of patients achieving CR with MRD negativity, DOR, PFS and overall survival (OS). 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 informed consent.
- Conditions
- B-Cell Acute Lymphoblastic Leukemia
- Being tested
- SYNCAR-100 Injection
- Keywords
- B-Cell Acute Lymphoblastic Leukemia, Relapsed Refractory Leukemia, CD19 Antigens, Chimeric Antigen Receptor T-Cells, circRNA, Nucleic Acids, Drug Safety, Clinical Study
- Medical subject headings
- Burkitt Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNCAR-100 InjectionDrug
Subjects will receive intravenous injections once weekly for a total of 4 injections.
| Study group | Role | What they receive |
|---|---|---|
| SYNCAR-100 Treatment Group | Experimental | Weekly intravenous (IV) administration for 4 doses. The investigator and sponsor may determine the dosing interval and number of doses for subsequent dose cohorts based on the safety/tolerability, pharmacokinetic parameters, clinical efficacy and prior clinical study experience of the 0.02 mg/kg dose cohort. Receives: Drug: SYNCAR-100 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events（AE）
Evaluated through laboratory investigations, 12-lead electrocardiography, and vital signs.
Measured: within 48 weeks post-dose
Secondary outcomes (8)
Overall Response Rate（ORR）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Measured: within 12 weeks and 48 weeks post-dose
Minimal Residual Disease（MRD）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Measured: within 12 weeks and 48 weeks post-dose
Duration of Response（DOR）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Measured: within 12 weeks and 48 weeks post-dose
Progression-Free Survival（PFS）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Measured: within 12 weeks and 48 weeks post-dose
Overall Survival（OS）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Measured: within 12 weeks and 48 weeks post-dose
Pharmacokinetics（PK）
Evaluated based on CAR copy number and other parameters in peripheral blood.
Measured: within 4 weeks post-dose
Pharmacodynamics（PD）
Peripheral blood cytokines within 48 weeks after SYNCAR-100 infusion.
Measured: within 48 weeks post-dose
Anti-Drug Antibody（ADA）
Anti-SYNCAR-100 antibodies (ADA) in peripheral blood within 48 weeks after SYNCAR-100 infusion.
Measured: within 48 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Bisheng (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429461
- Sponsor's protocol ID
- BSW-001-I
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SYNCAR-100 in the Treatment of CD19-Positive Relapsed or Refractory Acute B-Lymphoblastic Leukemia (R/R B-ALL)
- ClinicalTrials.gov ID
- NCT07429461
- Acronym / sponsor ID
- BSW-001-I
- Conditions
- B-Cell Acute Lymphoblastic Leukemia
- Keywords
- B-Cell Acute Lymphoblastic Leukemia, Relapsed Refractory Leukemia, CD19 Antigens, Chimeric Antigen Receptor T-Cells, circRNA, Nucleic Acids, Drug Safety, Clinical Study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Bisheng (Beijing) Biotechnology Co., Ltd.
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute lymphoblastic leukemia (ALL) is a hematologic malignancy characterized by the clonal abnormal proliferation and accumulation of lymphoid precursor cells (B or T lineage) in the bone marrow, peripheral blood and other organs. B-cell acute lymphoblastic leukemia (B-ALL) is the more common subtype, accounting for approximately 80% of all cases. For adult patients with relapsed or refractory B-ALL, only about 5-30% can achieve complete remission (CR) following salvage therapy. In addition, among patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), approximately 35% experience disease relapse, with a median overall survival of no more than 6 months; the estimated 1-year, 2-year and 5-year overall survival rates are about 30%, 15% and 10%, respectively. Relapse after allo-HSCT remains a major challenge in the treatment of hematologic malignancies, and there is no effective therapeutic approach recommended by clinical practice guidelines or consensus statements. Therapies such as retransplantation, donor lymphocyte infusion (DLI) and blinatumomab yield overall suboptimal efficacy, creating an urgent unmet medical need for novel and effective therapeutic strategies.
SYNCAR-100 is a next-generation nucleic acid drug candidate developed by Bisheng (Beijing) Biotechnology Co., Ltd. based on circular RNA (circRNA) technology. The safety of SYNCAR-100 will be evaluated by assessing indicators including dose-limiting toxicities (DLT), vital sign measurements, physical examinations, laboratory tests, 12-lead electrocardiography (ECG), peripheral blood B-cell and T-cell levels, and adverse events (AE). The efficacy of SYNCAR-100 in patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) will be evaluated by measuring endpoints including the overall response rate (ORR) within 12 weeks, the rate of complete remission with minimal residual disease (MRD)-negativity, duration of response (DOR), progression-free survival (PFS), as well as the ORR within 48 weeks, the rate of patients achieving CR with MRD negativity, DOR, PFS and overall survival (OS). 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 informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYNCAR-100 Treatment Group | Experimental | Drug: SYNCAR-100 InjectionWeekly intravenous (IV) administration for 4 doses. The investigator and sponsor may determine the dosing interval and number of doses for subsequent dose cohorts based on the safety/tolerability, pharmacokinetic parameters, clinical efficacy and prior clinical study experience of the 0.02 mg/kg dose cohort. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 1.Aged 18 to 75 years (inclusive), of any gender.
- 2.Karnofsky Performance Status score ≥ 70.
- 3.Estimated life expectancy ≥ 12 weeks.
- 4.Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood.
- 5.Confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) by bone marrow examination, and meeting one of the following criteria:
Key exclusion criteria (19 listed)
- 1.Isolated extramedullary leukemia or isolated extramedullary relapse.
- 2.Central nervous system (CNS) involvement of leukemia at CNS2 stage.
- 3.A history of other malignant tumors, except for the following: cured non-melanoma skin cancer, carcinoma in situ of the uterine cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other malignant tumors with disease-free survival for more than 5 years.
- 4.Positive test results for any of the following infectious diseases: HIV; HCV; HBsAg; positive HBcAb with concurrent positive HBV DNA copy number; TPPA.
- 5.Administration of live or attenuated live vaccines within 4 weeks prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYNCAR-100 InjectionSubjects will receive intravenous injections once weekly for a total of 4 injections. | Drug | SYNCAR-100 Treatment Group |
Primary outcome
Adverse events（AE）
Time frame: within 48 weeks post-dose
Evaluated through laboratory investigations, 12-lead electrocardiography, and vital signs.
8 secondary outcomes
Overall Response Rate（ORR）
Time frame: within 12 weeks and 48 weeks post-dose
Minimal Residual Disease（MRD）
Time frame: within 12 weeks and 48 weeks post-dose
Duration of Response（DOR）
Time frame: within 12 weeks and 48 weeks post-dose
Progression-Free Survival（PFS）
Time frame: within 12 weeks and 48 weeks post-dose
Overall Survival（OS）
Time frame: within 12 weeks and 48 weeks post-dose
Pharmacokinetics（PK）
Time frame: within 4 weeks post-dose
Pharmacodynamics（PD）
Time frame: within 48 weeks post-dose
Anti-Drug Antibody（ADA）
Time frame: within 48 weeks post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SYNCAR-100 Injection in people with B-Cell Acute Lymphoblastic Leukemia, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Huang, MD (13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events（AE） (time frame: within 48 weeks post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.