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B-cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT07830238

SNC116 Therapy for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

A Early Phase 1 study testing SNC116 in people with B-cell Acute Lymphoblastic Leukemia, run by Shanghai Simnova Biotechnology Co.,Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the safety and pharmacokinetic profile of SNC116 in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia 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?
SNC116
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
Sep 2026to Mar 2030
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

  • Participants must meet all of the following inclusion criteria to be enrolled in this study:
  • Age ≥ 18 years and ≤ 75 years, with no gender restrictions.
  • ECOG score 0 to 2.
  • Diagnosed with B-ALL through MICM (cytological morphology, immunology, cytogenetics, and molecular genetics), and tested positive for CD19 by flow cytometry or immunohistochemistry.
  • Recurrence or refractory B-ALL is defined as:
  • Early recurrence: Recurrence occurring within 12 months after the first complete remission;
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  • Primary refractory: Failure to achieve complete remission after two cycles of standardized chemotherapy;
  • ≥ 2 lines of systemic treatment for recurrence or refractory;
  • Recurrent or refractory after allogeneic hematopoietic stem cell transplantation (Allo-HSCT) (at least 6 months from the transplantation date to the administration date of SNC116);
  • For participants with Ph-positive disease, at least 2 different TKIs must have relapsed or been refractory, or the participant must be intolerant to TKI treatment, or have a TKI treatment contraindication, or be TKI-resistant (with T315i mutation or other resistance mechanisms).
  • Bone marrow morphology shows > 5% of primitive cells.
  • Participants who have received targeted CD19 therapy (including monoclonal antibodies, bispecific antibodies, ADCs, CAR-NK, experimental treatments, etc.) must have CD19 expression still present after the last targeted CD19 therapy (if the CD19 expression is a quantitative result, the positive CD19 in the primitive cells must be > 90%).
  • Expected survival is greater than 3 months.
  • Blood routine and lymphocyte subsets within 7 days before SNC116 administration meet the following requirements:
  • Absolute neutrophil count (ANC) ≥ 0.5 × 10^9/L;
  • Absolute lymphocyte count (ALC) ≥ 0.5 × 10^9/L;
  • Hemoglobin (Hb) ≥ 80 g/L;
  • Platelet count (PLT) ≥ 50 × 10^9/L;
  • CD3+ T cell absolute count ≥ 0.25 × 10^9/L.
  • Adequate liver, kidney, lung, and heart function, defined as:
  • Serum ALT and AST ≤ 2.5 times the upper limit of normal;
  • Total bilirubin ≤ 1.5 times the upper limit of normal, except for Gilbert syndrome patients, whose total bilirubin must be ≤ 3.0 times the upper limit of normal;
  • Creatinine clearance rate (estimated by Cockcroft-Gault formula) ≥ 50 ml/min;
  • Saturations of blood oxygen ≥ 92% under indoor ventilation conditions without clinical significance of pleural effusion;
  • Left ventricular ejection fraction ≥ 45%; Echocardiography shows no clinical significance of pericardial effusion; ECG has no clinical significance of abnormal findings.
  • Participants receiving hematopoietic growth factor support therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and platelet agonists (TPO), must have a 1-week interval between the last administration of growth factor support therapy and the screening period assessment; Participants receiving blood product transfusions must have a blood platelet assessment at least 1 week apart from the last platelet transfusion, and a blood hemoglobin assessment at least 1 week apart from the last red blood cell transfusion.
  • During the screening period, serum pregnancy test results of fertile female participants must be negative (women who have undergone surgical sterilization or have been menopausal for at least 2 years are considered to have no fertility). Fertile female participants and male participants must use highly effective contraceptive methods throughout the entire clinical study period and within one year after the last study treatment; they must also commit not to donate eggs (oocytes, oocyte cells) / sperm for assisted reproduction within one year after the last study treatment.
  • Participants must agree not to donate blood, organs, sperm / semen, and/or eggs after SNC116 treatment for at least one year. Currently, there is no sufficient data to confirm when donating any tissue is safe; therefore, participants should not donate any tissue after receiving SNC116.
  • Voluntarily participate in the clinical trial and sign the informed consent form.

Who cannot join

  • Participants who meet any of the following exclusion criteria will not be eligible to participate in this clinical study:
  • Diagnosed with Burkitt leukemia/lymphoma or chronic myeloid leukemia with acute lymphocytic transformation according to the WHO classification.
  • Recurrence with isolated extramedullary lesions.
  • Within the previous 2 years, had a malignant tumor that required treatment or had evidence of recurrence (excluding: fully cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, breast duct carcinoma in situ, thyroid cancer, and other localized carcinomas).
  • Known to have any allergic, hypersensitive, intolerant or contraindicated reaction to any component of SNC116 or the drugs used in the study (such as tocilizumab), or has previously experienced a severe allergic reaction.
  • Had received any treatment using vesicular virus G glycoprotein pseudotyped virus.
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  • Had CNS diseases:
  • (1) CNS-3; or with neurological changes CNS-2 (excluding those who have improved after treatment and are assessed by the investigator as meeting the criteria);
  • (2) Had seizures, cerebrovascular accidents (ischemia/haemorrhage), dementia, mental disorders, cerebellar diseases, any autoimmune disease involving the CNS, post-reversible encephalopathy syndrome (PRES), or brain edema, etc. severe CNS disease conditions.
  • Those with primary immunodeficiency or severe genetic diseases.
  • Had clinically significant major cardiovascular diseases, including any of the following:
  • Had myocardial infarction within 6 months before screening;
  • Had unstable angina pectoris within 3 months before screening;
  • Uncontrolled, clinically significant arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  • Mobitz II type II or III atrioventricular conduction block;
  • Congestive heart failure with NYHA classification ≥ 3;
  • Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) or with hypertensive crisis or hypertensive encephalopathy;
  • Had deep vein thrombosis or pulmonary embolism within 6 months before screening;
  • Other cardiovascular diseases that were assessed by the investigator as significantly high-risk and not suitable for enrollment.
  • Had ≥ 3 grade 3 gastrointestinal bleeding within the previous 1 month, a history of peptic ulcer disease, and the investigator assessed as having a risk of ≥ 3 grade 3 gastrointestinal bleeding or perforation (CTCAE 6.0).
  • Had active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening. Allowed participants to be enrolled if they had HBsAg positive and/or HBcAb positive but HBV-DNA negative, and/or HCVAb positive but HCV-RNA negative (if the research center reported reference value ranges, the normal upper limit of HBV-DNA and HCV-RNA detection was based on the detection values of each research center, and above the detection value limit was defined as "positive"; if the research center reported only "negative/positive", "positive" was based on the test report result).
  • Known positive serum HIV virus antibody or history of active HIV infection, and active syphilis patients.
  • Had active or latent Mycobacterium tuberculosis infection confirmed by clinical, imaging or laboratory examination during the screening period.
  • Had an uncontrolled active infection that required intravenous use of antibiotics, antiviral or antifungal drugs, etc. within 7 days before SNC116 administration.
  • At the time of screening, had a confirmed and requiring maintenance treatment systemic autoimmune disease or a confirmed systemic autoimmune disease in an active stage, except for: thyroid diseases assessed by the investigator as well-controlled.
  • Had received the following drugs/treatments before SNC116 administration:
  • Received salvage treatment (including chemotherapy, TKIs for Ph-positive ALL, and blinatumomab, etc.) within 1 week or 5 half-lives (whichever is shorter);
  • Received CNS prophylactic treatment within 1 week;
  • Received treatment doses of corticosteroid drugs (prednisone > 20 mg/day or equivalent doses of other steroid hormones), except for local application or prevention of allergic reactions;
  • Received prophylactic treatment with short-acting oral antiretroviral drugs;
  • Received local palliative radiotherapy within 2 weeks;
  • Received traditional Chinese medicine with anti-tumor indications within 2 weeks;
  • Received large molecule drug treatment within 3 weeks;
  • Received experimental drugs/treatment (except for clear placebo-controlled groups);
  • Experienced major surgery within 4 weeks;
  • Received live vaccines within 4 weeks;
  • Received immunosuppressants within 4 weeks;
  • Used any drugs for treating GVHD (such as calcineurin inhibitors, methotrexate, mycophenolate mofetil, rapamycin, thalidomide, etc.) within 4 weeks (except for calcium channel blockers, methotrexate, mycophenolate mofetil, rapamycin, thalidomide, etc.);
  • Received donor lymphocyte infusion (DLI) within 4 weeks;
  • Received lymphocytotoxic drugs such as fludarabine, chlorambucil, or cladribine within 3 months, or alemtuzumab or other lymphocytotoxic drugs within 6 months;
  • Received immune cell therapy such as CAR-T, CAR-NK, etc. within 3 months;
  • At the time of screening, any adverse events related to previous anti-leukemia treatment that have not recovered to ≤ grade 1 or baseline level (CTCAE version 6.0) (except for alopecia, hematological toxicity related to the inclusion criteria 8, or other grade 2 adverse events that have been converted to chronic stable state by the investigator, such as alternative treatment for hypothyroidism);
  • Previously received CD19 CAR-T cell therapy;
  • Experienced grade 4 neurotoxicity or grade 4 cytokine release syndrome during T-cell redirected immunotherapy;
  • Had any indwelling catheters or drainage tubes in the body (such as percutaneous nephrostomy tube, biliary drainage tube, or thoracic/abdominal/pericardial drainage catheter, etc.), except central venous catheterization and Ommaya reservoir;
  • Had 2-4 grade acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening; or had acute or chronic GVHD that required systemic treatment within 4 weeks before screening;
  • Pregnant or lactating women;
  • Other situations that the investigator considers may affect the safety or study compliance of the participants and are not suitable for participation in the 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

  • First Hospital of Jilin University

    Changchun, Jilin

Other trials in China

About this study

Official title: An Exploratory Clinical Study Evaluating the Safety and Pharmacokinetic Profile of SNC116 in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

This study aims to evaluate the safety and pharmacokinetic profile of SNC116 in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia

Being tested
SNC116
Keywords
in vivo CAR-T, CD19, B-ALL
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNC116Drug

    Subjects will receive SNC116 injection per different dose level

Study groups in NCT07830238
Study groupRoleWhat they receive
SNC116ExperimentalSubjects diagnosed with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Receives: Drug: SNC116

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Evaluation: The incidence rates, type and severity of all adverse events

    Measured: with 3 months after infusion

  2. Safety Evaluation: DLT

    Measured: with 28 days after infusion

Secondary outcomes (5)

  1. The overall response rate (ORR)

    Measured: up to 3 months post-infusion

  2. Bone marrow minimal residual disease (MRD) negativity rates

    Measured: up to 3 months post-infusion

  3. Duration of Response (DOR)

    Measured: The assessment period began at infusion and continued until the first occurrence of documented progression, initiation of new anti-leukemia treatment, loss to follow-up, or death, whichever came first, with an expected maximum of 15 years.

  4. Event-free survival (EFS)

    Measured: The assessment period began at infusion and continued until the first occurrence of documented progression, initiation of new anti-leukemia treatment, loss to follow-up, or death, whichever came first, with an expected maximum of 15 years.

  5. Overall Survival (OS)

    Measured: The assessment period began at infusion and continued until the first occurrence of documented progression, initiation of new anti-leukemia treatment, loss to follow-up, or death, whichever came first, with an expected maximum of 15 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07830238
Sponsor's protocol ID
SNC116-102
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently, this information is not shared. Should any future sharing arrangements be established, relevant updates will be promptly communicated through this channel.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SNC116 in people with B-cell Acute Lymphoblastic Leukemia, run by Shanghai Simnova Biotechnology Co.,Ltd. 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 29 inclusion and 48 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: opening soon, as of the sponsor's last update on 21 Sep 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Evaluation: The incidence rates, type and severity of all adverse events (time frame: with 3 months after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07830238.

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 21 Sep 2026.

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