AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 1NCT06008405

Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy

A Phase 1 study testing TQB2928 Injection + Azacitidine for injection in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study carried out a phase Ib clinical trial of TQB2928 injection combined therapy in patients with hematological malignancies, to explore the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TQB2928 injection combined with azacitidine for injection in Acute Myeloid Leukemia… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
TQB2928 Injection + Azacitidine for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
9 sitesChina
Study dates
Sep 2023to May 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily join this study, sign the informed consent form, and have good compliance;
  • Age: age ≥ 18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2 points; expected survival time of more than 3 months;
  • Subject population:
  • The subjects were diagnosed with AML or MDS according to the World Health Organization (WHO) 2016 revised classification criteria for hematopoietic and lymphoid tissue tumors.
  • MDS adopts the revised International Prognostic Scoring System (IPSS-R) > 3.5 (higher risk group), and the proportion of bone marrow blasts ≥ 5%.
  • Phase 1 (dose escalation phase) and Phase 2 (dose expansion phase) enrollment
Show all 11Show fewer
  • Untreated AML who cannot tolerate standard induction chemotherapy;
  • Untreated higher-risk MDS;
  • The main organs function well.
  • Subjects must be willing to provide available diagnostic evidence or perform bone marrow aspiration and biopsy before the study treatment and must be willing to perform bone marrow aspiration and biopsy after receiving the study treatment.
  • Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating subjects; male subjects should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.

Who cannot join

  • Tumor disease and medical history:
  • central nervous system leukemia;
  • Other malignant tumors have occurred or are currently suffering from other malignant tumors within 3 years. The following two conditions can be included: other malignancies treated by a single surgery, achieving 5 years of continuous disease-free survival (DFS);
  • Clinically significant uncontrolled pleural effusion, ascites, moderate or more remarkable pericardial effusion requiring repeated drainage.
  • Previous anti-tumor therapy:
  • Previous use of other drugs targeting the CD47/signal-regulatory protein α (SIRPα) signaling pathway;
Show all 52Show fewer
  • Received any antibody drug treatment under investigation within 4 weeks before the first administration, received Chimeric Antigen Receptor -T (CAR-T) therapy, or other immune cell therapy, or autologous hematopoietic stem cell transplantation 3 months before the first administration;
  • Previously received allogeneic hematopoietic stem cell transplantation;
  • Received any major surgery, chemotherapy and/or radiotherapy, immunotherapy or targeted therapy within 4 weeks before the first administration;
  • The first administration is less than 5 drug half-lives from the previous oral targeted therapy (calculated from the end of the last treatment);
  • Received Chinese patent medicines with anti-tumor indications within 2 weeks before the first administration, including compound mylabris capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, javanica oil, Xiao'ai ping tablet/injection, cinobufagin capsule, etc., (using symptomatic treatment such as hydroxyurea, leukocyte apheresis and erythropoietin and other hematopoietic growth factors within 7 days is allowed);
  • Combined diseases and medical history:
  • Liver abnormalities:
  • Decompensated cirrhosis (Child-Pugh liver function grade B or C);
  • Hepatitis B virus infection;
  • Hepatitis C virus infection;
  • Kidney abnormalities:
  • Renal failure requires hemodialysis or peritoneal dialysis;
  • history of nephrotic syndrome.
  • Gastrointestinal abnormalities:
  • Persistent chronic diarrhea despite maximal medical treatment;
  • Active inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) within 4 weeks before the first dose.
  • Cardiovascular and cerebrovascular abnormalities:
  • Concomitant or previous history of central nervous system disease, including seizures, hemorrhagic/ischemic stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, paralysis, aphasia, mental illness, disturbance of consciousness, unknown Cause coma, neuropathy, organic brain syndrome, etc.;
  • Brain Magnetic Resonance Imaging (MRI) evidence of inflammatory lesions and/or vasculitis;
  • Cerebrovascular accident, cerebral infarction, etc., occurred within 6 months before the first administration;
  • Arterial/venous thrombosis events such as deep vein thrombosis and pulmonary embolism occurred within 6 months before the first administration;
  • Accompanying or previous history of cardiovascular disease, including grade III or IV heart failure defined by the New York Heart Association classification, atrioventricular block of grade II and above, myocardial infarction within 6 months before the first dose, severe History of arrhythmia, unstable angina, etc.;
  • Hypertension that cannot be controlled by the combination of two drugs (at least 2 measurements are systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg);
  • Previously or currently suffering from heart valvulitis and endarteritis.
  • History of immunodeficiency:
  • Known human immunodeficiency virus (HIV) infection or other acquired or congenital immunodeficiency diseases;
  • Prepare to undergo or have previously received organ transplantation or have noticeable host transplantation reactions;
  • Need to receive systemic immunosuppressant therapy, including but not limited to the use of cyclosporine, tacrolimus, etc., within 4 weeks before the first administration, and receive high-dose glucocorticoid therapy (prednisone >30 mg /day or other glucocorticoids at equivalent doses), or those with autoimmune diseases, allergic diseases or immune rejection receiving any other immunosuppressive therapy. Patients receiving inhaled or topical corticosteroids or prednisone < 10 mg/day or equivalent doses of other systemic corticosteroids at a stable dose for at least 4 weeks before the first dose or receiving Prophylactic medication to prevent infusion reactions can be selected.
  • Uncontrolled active systemic bacterial, fungal, or viral infection.
  • Unexplained fever > 38.5 ℃ occurred during screening or before the first medication (except for fever caused by tumors judged by the investigator).
  • Subjects with any history of hemolytic anemia (including Evans syndrome) or positive Coombs test within 3 months before the first administration.
  • Lung disease:
  • Blood oxygen saturation ≤ 95% at rest;
  • Previous or current noninfectious pneumonia requiring corticosteroid therapy (including but not limited to acute respiratory distress syndrome, acute hypersensitivity pneumonia, drug-associated pneumonia, bronchospasm, acute interstitial pneumonia, idiopathic pulmonary interstitial fibrosis, etc.);
  • Evidence of active pneumonia found on chest Computed Tomography (CT) scan during the screening period;
  • Active tuberculosis.
  • A history of severe allergies of unknown causes; known allergies to monoclonal antibody drugs or exogenous human immunoglobulins; known allergies to study drug excipients.
  • Combined with serious or not well-controlled concomitant diseases that, according to the investigator's judgment, seriously endanger the subject's safety or affect the study's completion.
  • With or previous history of pituitary or adrenal dysfunction (as assessed by the investigator).
  • History of drug abuse or drug abuse.
  • myelodysplastic syndromes (MDS) subjects combined with the following two conditions: uncorrected folic acid and vitamin B12 deficiency MDS transformed from pre-existing myeloproliferative neoplasms (MPN) or MDS/MPN types that meet the World Health Organization (WHO) 2016 classification criteria, including chronic Myeloid leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myeloid leukemia (JMML).
  • M3 type acute myeloid leukemia (AML) and AML with positive BCR-ABL mutation gene.
  • Inoculation within 4 weeks before the first administration or vaccination with live attenuated vaccine during the planned study period.
  • Participated in other drug clinical trials within the past 30 days.
  • It is estimated that the compliance of patients participating in this clinical research needs to be improved.
  • Hypersensitivity to azacitidine or mannitol;

Trial locations and contacts

9 sites in 1 country.

Weili Zhao, Doctor contact

+86 021-64150275

zwl_trail@163.com

Hongyan Tong, Doctor contact

+86 18120165251

tonghongyan@zju.edu.cn

9 sites in 1 country

China9 sites, 9 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Hao Jiang, Doctor, +86 13601164350, Jiangha0090@sina.com

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Sujun Gao, Doctor, +86 15843073208, sujung1963@qq.com

    Not yet recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Ying Li, Doctor, +86 13607499962, 13538563@qq.com

    Not yet recruiting

  • Chongqing Hospital of Traditional Chinese Medicine

    Chongqing, Chongqing Municipality, 400011

    Weiqi Nian, Doctor, 13883652913, nwqone@126.com

    Not yet recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006

    Hongyan Tong, Doctor, +8618120165251, tonghongyan@zju.edu.cn

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Fei Li, Doctor, +86 13970038386, lifeigcp2022@163.com

    Not yet recruiting

  • Shanghai Jiaotong University, School of Medicine, Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    Weili Zhao, Doctor, +862164150275, zwl_trail@163.com

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Xiaojing Yan, Doctor, +86 13889128302., 13538563@qq.com

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Xudong Wei, Doctor, +86 13837169301, weixudong63@126.com

    Not yet recruiting

Other trials in China

About this study

Official title: Phase Ib Clinical Trial of TQB2928 Injection Combination Therapy in Patients With Hematological Malignancies

This study carried out a phase Ib clinical trial of TQB2928 injection combined therapy in patients with hematological malignancies, to explore the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TQB2928 injection combined with azacitidine for injection in Acute Myeloid Leukemia (AML)/Myelodysplastic Syndromes (MDS) subjects.

Being tested
TQB2928 Injection + Azacitidine for injection
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

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

  • TQB2928 Injection + Azacitidine for injectionDrug

    TQB2928 injection is a fully humanized Immunoglobulin G 4 (IgG4) subtype monoclonal antibody targeting CD47.

    Azacitidine for injection is a nucleoside metabolism inhibitor that inhibits DeoxyriboNucleic Acid (DNA) methyltransferase, reduces DNA methylation and alters gene expression.

Study groups in NCT06008405
Study groupRoleWhat they receive
TQB2928 Injection + Azacitidine for injectionExperimentalDose escalation: Intravenous infusion of TQB2928 Injection once a week, combined with azacitidine for injection (75 mg/m2, d1-7/q4w), 4 weeks (28 days) as a treatment cycle. Dose expansion: The maximum tolerated dose (MTD) or optimal biological dose (OBD) or recommended phase II dose (RP2D) determined in the dose-escalation phase is combined with azacitidine for injection for extended studies to further observe the safety and efficacy.
Receives: Drug: TQB2928 Injection + Azacitidine for injection

What is being measured

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

  1. Incidence of Adverse Events (AEs)

    Adverse events refer to all adverse medical events that occur after patients receive the experimental drug, which can be manifested as symptoms, signs, diseases or abnormal laboratory tests, but do not necessarily have a causal relationship with the experimental drug. Evaluated by Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).

    Measured: Up to 2 years.

  2. Incidence of serious adverse events (SAEs)

    Incidence of serious adverse events (SAEs) evaluated by CTCAE 5.0.

    Measured: Up to 2 years.

  3. Severity of serious adverse events (SAEs)

    Severity of serious adverse events (SAEs) evaluated by CTCAE 5.0.

    Measured: Up to 2 years.

Secondary outcomes (17)

  1. The area under the curve (AUC)

    The area under the curve (AUC) of serum or plasma concentration of TQB2928

    Measured: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.

  2. Peak concentration (Cmax)

    Maximum observed concentration of TQB2928

    Measured: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.

  3. Peak Time (Tmax)

    Time to reach maximum concentration of TQB2928

    Measured: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.

  4. Incidence of anti-drug antibody (ADA)

    Incidence of anti-drug antibody (ADA)

    Measured: Cycle1 Day1 and Cycle 5 Day 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; 90 days after last dose; Each cycle is 28 days.

  5. AML: Objective Response Rate (ORR)

    Defined as the percentage of Complete Response (CR) plus partial response (PR) plus Complete Response with incomplete hematological recovery (CRi) plus Morphological absence of leukemia status (MLFS) plus Complete Response with incomplete hematological recovery (CRh)

    Measured: Up to 2 years.

  6. AML: Duration of Response (DOR)

    For all patients with a best response of CR, CRh, CRi, MLFS, or PR, the time from the date of first achieved remission to the date of first documented disease progression/relapse/treatment failure or death, whichever occurs first.

    Measured: Up to 2 years.

  7. AML: Time to CR+CRh+CRi

    The time from the date of first TQB2928 injection treatment to the date of first CR, CRh or CRi among all patients whose best response was CR, CRh or CRi.

    Measured: Up to 2 years.

  8. AML: Event-free survival (EFS)

    Refers to the time from the date of receiving the first TQB2928 injection treatment to the first clearly recorded date of recurrence after remission, disease progression/treatment failure or death, whichever occurs first.

    Measured: Up to 2 years.

  9. AML: Relapse-Free Survival (RFS)

    Refers to the time from the date of remission to the first clearly recorded hematological relapse or death from any cause for patients who have achieved CR, CRh, or CRi, whichever occurs first.

    Measured: Up to 2 years.

  10. AML: Overall survival (OS)

    The time from the date of receiving the first TQB2928 injection treatment to the date of death from any cause.

    Measured: Up to 2 years.

  11. MDS: Complete Response (CR) Rate

    Proportion of patients whose best response is Complete Response

    Measured: Up to 2 years.

  12. MDS: Objective Response Rate (ORR)

    Proportion of patients with best response in CR, Complete molecular remission (mCR), PR or hematological remission

    Measured: Up to 2 years.

  13. MDS: Improvement in Transfusion Independence

    Proportion of patients who were transfusion dependent at baseline who were free of red-blood-cell (RBC)/platelet transfusion after first dose.

    Measured: Up to 2 years.

  14. MDS: Progression Free Survival (PFS)

    From the date of receiving the first TQB2928 injection treatment to the first documented time to investigator-assessed disease progression/relapse after CR or death from any cause.

    Measured: Up to 2 years.

  15. MDS: Leukemia-free survival

    From the date of receiving the first TQB2928 injection treatment to the blast cells in bone marrow/peripheral blood exceeding 20%, or the time of diagnosis of extramedullary acute leukemia, or death due to any cause.

    Measured: Up to 2 years.

  16. MDS: Change from Baseline in Quality of Life (QoL) Score

    Proportion of patients with a confirmed improvement of at least 10 points from baseline in overall health status/ QoL score assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30)

    Measured: Up to 2 years.

  17. MDS: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    Proportion of patients with confirmed improvement of at least 3 points from baseline in FACIT-Fatigue score

    Measured: Up to 2 years.

Timeline

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

  1. First posted23 Aug 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008405
Sponsor's protocol ID
TQB2928-Ib-01
Status last verified
Mar 2023
First submitted
18 Aug 2023
Last updated
6 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB2928 Injection + Azacitidine for injection in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites 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 11 inclusion and 52 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weili Zhao, Doctor (+86 021-64150275, zwl_trail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Up to 2 years.). The study lists 3 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 NCT06008405.

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 6 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in