Acute Lymphocytic LeukemiaA-319NCT07371533
Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319)
A study testing Treatment with A319 in people with Acute Lymphocytic Leukemia, run by Shanxi Bethune Hospital.
Trial summary
This is an exploratory study with an open-label, single-arm, single-center design. It plans to enroll subjects with refractory/relapsed acute B-cell lymphoblastic leukemia (B-ALL), or treatment-naive or previously treated B-ALL subjects who achieved complete remission (CR) after induction chemotherapy but still have… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Lymphocytic Leukemia
- What is being tested?
- Treatment with A319
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 31 Jan 2028
- Phase
- Interventional
- 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
- All of the following criteria must be met for refractory/relapsed acute B-cell lymphoblastic leukemia:
- 1.Aged 18 to 75 years (inclusive), regardless of gender;
- 2.Confirmed diagnosis of refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL) with positive CD19 expression. Definition of refractory or relapsed: failure to respond to conventional induction chemotherapy; early relapse (relapse within 12 months of first remission); relapse after 12 months of first remission with failure to achieve remission following re-induction with the original regimen; second or subsequent relapse, relapse after autologous hematopoietic stem cell transplantation (Auto-HSCT), or relapse after allogeneic hematopoietic stem cell transplantation (Allo-HSCT). (For patients with Philadelphia chromosome-positive [Ph+] disease, they must have received treatment with at least one tyrosine kinase inhibitor [TKI].);
- 3.Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- 4.Bone marrow blast percentage of at least 5% (determined by morphology);
- 5.Expected life expectancy of at least 3 months;
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- 6.Ability to sign the informed consent form and comply with protocol requirements; if the patient is unable to sign, their legal guardian or representative must sign on their behalf.
- All of the following criteria must be met for acute B-cell lymphoblastic leukemia (B-ALL) with positive minimal residual disease (MRD) despite achieving complete remission (CR) via induction chemotherapy:
- 1.Aged 18 to 75 years (inclusive), regardless of gender;
- 2.Confirmed diagnosis of acute B-cell lymphoblastic leukemia (B-ALL) with positive CD19 expression;
- 3.B-ALL that has achieved complete morphological remission (CR) via at least 2 cycles of induction chemotherapy# but remains minimal residual disease (MRD)-positive. MRD positivity is defined as detectable nucleated blast cells ≥ 10-⁴. (For patients with Philadelphia chromosome-positive [Ph+] disease, they must have received treatment with tyrosine kinase inhibitors [TKIs] combined with chemotherapy);
- 4.Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- 5.Ability to sign the informed consent form and comply with protocol requirements; if the patient is unable to sign, their legal guardian or representative must sign on their behalf.
Who cannot join
- 1.Central nervous system (CNS) leukemia (confirmed by cerebrospinal fluid [CSF] analysis) or acute lymphoblastic leukemia (ALL) with clinically relevant CNS involvement;
- 2.Burkitt's leukemia, testicular infiltration in acute lymphoblastic leukemia (ALL);
- 3.A history of malignancy other than ALL within 5 years prior to the initiation of protocol-specific treatment. Exceptions include: malignancies treated with curative intent, with no known active disease for 5 years before enrollment, and deemed by the treating physician to have a low recurrence risk; non-melanoma skin cancer or lentigo maligna that has been adequately treated with no evidence of recurrence; carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrence; ductal carcinoma in situ of the breast that has been adequately treated with no evidence of recurrence;and prostatic intraepithelial neoplasia with no evidence of prostate cancer;
- 4.Patients with grade 2-4 acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or those with chronic GVHD requiring immunosuppressive therapy;
- 5.Receipt of autologous hematopoietic stem cell transplantation (Auto-HSCT) within 6 weeks, or allogeneic hematopoietic stem cell transplantation (Allo-HSCT) within 3 months, prior to the start of study drug treatment;
- 6.Concurrent chemotherapy, radiotherapy, or systemic treatment for GVHD within 2 weeks prior to the start of study drug treatment;
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- 7.Patients with diseases, medical conditions, or social factors that, in the investigator's judgment, may affect study results or compliance. The protocol specifies the following conditions that disqualify patients from participating in the study: uncontrolled acute infection or confirmed bacteremia; known human immunodeficiency virus (HIV) infection, or acute hepatitis B or hepatitis C; patients with severe dyspnea, impaired pulmonary function, or requiring continuous oxygen supplementation; New York Heart Association (NYHA) heart failure classification of grade 3 or 4; myocardial infarction, unstable angina, stroke, transient ischemic attack, severe arrhythmia, or uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) within 6 months prior to drug administration;
- 8.Laboratory test requirements are as follows: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN), or > 5 × ULN if liver metastasis is present; total bilirubin > 1.5 × ULN;creatinine clearance < 50 mL/min (calculated using the Cockroft-Gault formula); coagulation function: International Normalized Ratio (INR) > 1.6 (unless on anticoagulant therapy);for patients on oral anticoagulant therapy with a stable dose (for at least 14 days) (e.g., warfarin), INR must be ≤ 3.0 with no bleeding tendency (i.e., no bleeding within 14 days prior to the first dose of the study drug); use of low-molecular-weight heparin is permitted for subjects;
- 9.Previous receipt of anti-CD19 therapy (including CAR-T cell therapy), or immunotherapy (e.g., rituximab) within 4 weeks prior to A-319 treatment;
- 10:Presence of adverse events (except alopecia) caused by anti-tumor treatment that have not resolved to grade 1;
- 11.Pregnant women (positive pregnancy test), lactating women, or women of childbearing potential who refuse to use contraception from the time of signing the informed consent form until at least 3 months after the end of the study; women of childbearing potential must have a positive pregnancy test (human chorionic gonadotropin [HCG] test) within 7 days prior to Day 1 of treatment;
- 12.Male patients (except those who have undergone surgical sterilization) who refuse to use contraception from the time of signing the informed consent form until at least 3 months after the end of the study;
- 13.Known hypersensitivity to the study drug or its excipients;
- 14.Patients deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Recombinant Anti-CD19m-CD3 Antibody Injection (A-319) for Refractory/Relapsed or MRD-Positive After Induction Chemotherapy Acute B-Cell Lymphoblastic Leukemia (B-ALL) Clinical Study
This is an exploratory study with an open-label, single-arm, single-center design. It plans to enroll subjects with refractory/relapsed acute B-cell lymphoblastic leukemia (B-ALL), or treatment-naive or previously treated B-ALL subjects who achieved complete remission (CR) after induction chemotherapy but still have positive minimal residual disease (MRD). The primary objectives are to preliminarily evaluate the safety, tolerability, pharmacokinetics, biology, preliminary efficacy, and immunogenicity of A-319 subcutaneous injection.
- Conditions
- Acute Lymphocytic Leukemia
- Being tested
- Treatment with A319
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with A319Drug
The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, the corresponding treatment dose will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period.
| Study group | Role | What they receive |
|---|---|---|
| 1.8 μg/kg dose group | Experimental | The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, a treatment dose of 1.8 μg/kg will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period. Receives: Drug: Treatment with A319 |
| 3.6 μg/kg dose group | Experimental | The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, a treatment dose of 3.6 μg/kg will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period. Receives: Drug: Treatment with A319 |
| 5.0 μg/kg dose group | Experimental | The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, a treatment dose of 5.0 μg/kg will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period. Receives: Drug: Treatment with A319 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Analysis
Safety will be evaluated based on the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Measured: From the signing of the informed consent form to 30 days after the last dose
Characteristics of Dose-Limiting Toxicity (DLT)
Dose Limiting Toxicity (DLT) is defined as the occurrence of Grade 3 or higher non-hematologic toxicity (including neurotoxicity) during the first cycle (4 weeks of treatment plus 2 weeks of treatment holiday).
Measured: During the first cycle (each cycle lasts 42 days)
Secondary outcomes (18)
Peripheral Blood Lymphocyte Count
Pharmacodynamic endpoints:Detection of CD20+, CD19+, CD3+ T cells, CD4+ T cells, and CD8+ T cells.
Measured: No more than 4 cycles (each cycle is 42 days)
Maximum Concentration (Cmax)
Pharmacokinetic endpoints
Measured: During the first cycle (each cycle lasts 42 days)
Mean
It will be evaluated based on the levels of cytokines (IL-2, IL-4, IL-6, IL-8, IL-10, IFNγ, TNFα, IL-1β) in peripheral blood.
Measured: During the first cycle (each cycle lasts 42 days)
Best response rate
Hematologic Complete Remission (CR) or Hematologic Complete Remission with Incomplete Hematologic Recovery (CRi)
Measured: No more than 4 cycles (each cycle is 42 days)
Minimal Residual Disease (MRD) Response Rate
Measured: No more than 4 cycles (each cycle is 42 days)
Time to Hematologic Relapse
Duration of Response, DOR
Measured: 4 cycles (each cycle is 42 days) plus a 12-month survival follow-up period
Relapse-Free Survival (RFS)
Measured: Within 2 years
Overall Survival (OS)
Measured: Within 2 years
Percentage of subjects who undergo allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after achieving complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or minimal residual disease (MRD) negativity followi
Measured: Within 2 years
Immunogenicity
Number and percentage of subjects who develop anti-A-319 antibodies (ADA)
Measured: No more than 4 cycles (each cycle is 42 days)
Time to Maximum Concentration (Tmax)
Pharmacokinetic endpoints
Measured: During the first cycle (each cycle lasts 42 days)
Area Under the Concentration-Time Curve (AUC)
Pharmacokinetic endpoints
Measured: During the first cycle (each cycle lasts 42 days)
Mean Residence Time (MRT)
Pharmacokinetic endpoints
Measured: During the first cycle (each cycle lasts 42 days)
Apparent Volume of Distribution (Vd)
Pharmacokinetic endpoints
Measured: During the first cycle (each cycle lasts 42 days)
Total Clearance (CL/F)
Pharmacokinetic endpoints
Measured: During the first cycle (each cycle lasts 42 days)
Volume of Distribution (Vz/F)
Pharmacokinetic endpoints
Measured: During the first cycle (each cycle lasts 42 days)
Standard Deviation (SD)
Detection of biomarkers (serum cytokines): Interleukin-2 (IL-2), Interleukin-4 (IL-4), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), and Interleukin-1β (IL-1β)
Measured: During the first cycle (each cycle lasts 42 days)
Coefficient of Variation (CV)
Detection of biomarkers (serum cytokines): Interleukin-2 (IL-2), Interleukin-4 (IL-4), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), and Interleukin-1β (IL-1β)
Measured: During the first cycle (each cycle lasts 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371533
- Sponsor's protocol ID
- IM-2025-06
- Acronym
- A-319
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Anti-CD19m-CD3 Antibody Injection (A-319) for Refractory/Relapsed or MRD-Positive After Induction Chemotherapy Acute B-Cell Lymphoblastic Leukemia (B-ALL) Clinical Study
- ClinicalTrials.gov ID
- NCT07371533
- Acronym / sponsor ID
- A-319 / IM-2025-06
- Conditions
- Acute Lymphocytic Leukemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 28 Jan 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.
This is an exploratory study with an open-label, single-arm, single-center design. It plans to enroll subjects with refractory/relapsed acute B-cell lymphoblastic leukemia (B-ALL), or treatment-naive or previously treated B-ALL subjects who achieved complete remission (CR) after induction chemotherapy but still have positive minimal residual disease (MRD). The primary objectives are to preliminarily evaluate the safety, tolerability, pharmacokinetics, biology, preliminary efficacy, and immunogenicity of A-319 subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.8 μg/kg dose group | Experimental | Drug: Treatment with A319The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, a treatment dose of 1.8 μg/kg will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period. |
| 3.6 μg/kg dose group | Experimental | Drug: Treatment with A319The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, a treatment dose of 3.6 μg/kg will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period. |
| 5.0 μg/kg dose group | Experimental | Drug: Treatment with A319The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, a treatment dose of 5.0 μg/kg will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All of the following criteria must be met for refractory/relapsed acute B-cell lymphoblastic leukemia:
- 1.Aged 18 to 75 years (inclusive), regardless of gender;
- 2.Confirmed diagnosis of refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL) with positive CD19 expression. Definition of refractory or relapsed: failure to respond to conventional induction chemotherapy; early relapse (relapse within 12 months of first remission); relapse after 12 months of first remission with failure to achieve remission following re-induction with the original regimen; second or subsequent relapse, relapse after autologous hematopoietic stem cell transplantation (Auto-HSCT), or relapse after allogeneic hematopoietic stem cell transplantation (Allo-HSCT). (For patients with Philadelphia chromosome-positive [Ph+] disease, they must have received treatment with at least one tyrosine kinase inhibitor [TKI].);
- 3.Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- 4.Bone marrow blast percentage of at least 5% (determined by morphology);
Key exclusion criteria (14 listed)
- 1.Central nervous system (CNS) leukemia (confirmed by cerebrospinal fluid [CSF] analysis) or acute lymphoblastic leukemia (ALL) with clinically relevant CNS involvement;
- 2.Burkitt's leukemia, testicular infiltration in acute lymphoblastic leukemia (ALL);
- 3.A history of malignancy other than ALL within 5 years prior to the initiation of protocol-specific treatment. Exceptions include: malignancies treated with curative intent, with no known active disease for 5 years before enrollment, and deemed by the treating physician to have a low recurrence risk; non-melanoma skin cancer or lentigo maligna that has been adequately treated with no evidence of recurrence; carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrence; ductal carcinoma in situ of the breast that has been adequately treated with no evidence of recurrence;and prostatic intraepithelial neoplasia with no evidence of prostate cancer;
- 4.Patients with grade 2-4 acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or those with chronic GVHD requiring immunosuppressive therapy;
- 5.Receipt of autologous hematopoietic stem cell transplantation (Auto-HSCT) within 6 weeks, or allogeneic hematopoietic stem cell transplantation (Allo-HSCT) within 3 months, prior to the start of study drug treatment;
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 |
|---|---|---|
| Treatment with A319The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, the corresponding treatment dose will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period. | Drug | 1.8 μg/kg dose group, 3.6 μg/kg dose group, 5.0 μg/kg dose group |
Primary outcome
Safety Analysis
Time frame: From the signing of the informed consent form to 30 days after the last dose
Safety will be evaluated based on the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Characteristics of Dose-Limiting Toxicity (DLT)
Time frame: During the first cycle (each cycle lasts 42 days)
Dose Limiting Toxicity (DLT) is defined as the occurrence of Grade 3 or higher non-hematologic toxicity (including neurotoxicity) during the first cycle (4 weeks of treatment plus 2 weeks of treatment holiday).
18 secondary outcomes
Peripheral Blood Lymphocyte Count
Time frame: No more than 4 cycles (each cycle is 42 days)
Maximum Concentration (Cmax)
Time frame: During the first cycle (each cycle lasts 42 days)
Mean
Time frame: During the first cycle (each cycle lasts 42 days)
Best response rate
Time frame: No more than 4 cycles (each cycle is 42 days)
Minimal Residual Disease (MRD) Response Rate
Time frame: No more than 4 cycles (each cycle is 42 days)
Time to Hematologic Relapse
Time frame: 4 cycles (each cycle is 42 days) plus a 12-month survival follow-up period
Relapse-Free Survival (RFS)
Time frame: Within 2 years
Overall Survival (OS)
Time frame: Within 2 years
Percentage of subjects who undergo allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after achieving complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or minimal residual disease (MRD) negativity followi
Time frame: Within 2 years
Immunogenicity
Time frame: No more than 4 cycles (each cycle is 42 days)
Time to Maximum Concentration (Tmax)
Time frame: During the first cycle (each cycle lasts 42 days)
Area Under the Concentration-Time Curve (AUC)
Time frame: During the first cycle (each cycle lasts 42 days)
Mean Residence Time (MRT)
Time frame: During the first cycle (each cycle lasts 42 days)
Apparent Volume of Distribution (Vd)
Time frame: During the first cycle (each cycle lasts 42 days)
Total Clearance (CL/F)
Time frame: During the first cycle (each cycle lasts 42 days)
Volume of Distribution (Vz/F)
Time frame: During the first cycle (each cycle lasts 42 days)
Standard Deviation (SD)
Time frame: During the first cycle (each cycle lasts 42 days)
Coefficient of Variation (CV)
Time frame: During the first cycle (each cycle lasts 42 days)
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 28 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with A319 in people with Acute Lymphocytic Leukemia, run by Shanxi Bethune Hospital.
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 13 inclusion and 14 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Weiwei tian (13485304136, Tianweiwei@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Analysis (time frame: From the signing of the informed consent form to 30 days after the last dose). 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?
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 28 Jan 2026.