Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic SyndromesPhase 1NCT05426798
Clinical Study of TQB2618 Injection in Combination With Demethylation Drugs in Patients With Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Phase 1 study testing TQB2618 injection azacitidine, AZA decitabine, DAC in people with Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- TQB2618 injection azacitidine, AZA decitabine, DAC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2022to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Subjects with medium-high risk recurrent/refractory International Prognostic Scoring System (IPSS-R) myelodysplastic syndromes(MDS) and acute myelocytic leukemia(AML) clearly diagnosed by pathology, who were intolerant to other medications and judged by the investigator to have no other appropriate treatment.
- 2 ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- 3 The function of main organs is normal.
- 4 Subjects must need to adopt effective methods of contraception.
- 5 Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
Who cannot join
- 1 Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- 2 Patients diagnosed with acute promyelocytic leukemia or Philadelphia Chromosome-Positive Acute Myeloid Leukemia (Ph+AML) , or low-risk relapsed and refractory AML who only received second-line therapy;
- 3 The non-hematologic toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (excluding hair loss).
- 4 Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before treatment.
- 5 The subjects had any history of bleeding or coagulopathy or who were being treated with anticoagulant.
- 6 Subjects had an arteriovenous thrombosis event within 6 months.
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- 7 History of drug abuse, alcohol or drug abuse or mental disorder. Subjects who have epilepsy and require treatment.
- 8 Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg);
- 9 Subjects who had received allogeneic stem cell transplantation or autologous stem cell transplantation within 3 months；
- 10 Subjects with ≥ grade 2 myocardial ischemia or infarction, arrhythmia, prolonged QTc interval (including male QTc ≥450ms, female QTc ≥470ms) and ≥ grade 2 congestive heart failure with New York Heart Association (NYHA )classification；
- 11 Active or uncontrolled severe infection ≥common terminology criteria for adverse events （CTCAE） grade 2 infection)；
- 12 Subjects with active hepatitis.
- 13 The subjects was diagnosed with renal failure and required hemodialysis or peritoneal dialysis.
- 14 History of immunodeficiency, including positive human immunodeficiency virus (HIV) test or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- 15 Poor control of diabetes (fasting glucose GLU > 10mmol/L);
- 16 Subjects who have received radiation therapy or the treatment of proprietary Chinese medicines with anti-tumor indications clearly stated in the National Medical Products Administration (NMPA) approved drug instructions within 4 weeks of starting treatment.
- 17 Uncontrolled pleural effusion, pericardial effusion or ascites;
- 18 Subjects with central nervous system aggression;
- 19 Vaccination history of live attenuated vaccine before 4 weeks of starting treatment, or planned vaccination of live attenuated vaccine during the study period.
- 20 History of severe allergy to study drugs and pharmaceutical excipients .
- 21 Subjects diagnosed with active autoimmune disease within 2 years before starting treatment.
- 22 Receiving any other investigational agent within 4 weeks before first dose.
- 23 According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Yu Wu, 18980601973, wuyulily@hotmail.com
About this study
Official title: Phase I Clinical Study of TQB2618 Injection in Combination With Demethylation Drugs in Patients With Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the tolerability and initially evaluate the antitumor efficacy of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
- Being tested
- TQB2618 injection azacitidine, AZA decitabine, DAC
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2618 injection azacitidine, AZA decitabine, DACDrug
Drug1: TQB2618 injection is a novel tim-3 inhibitor.
Drug2: Azacitidine (5-azacytidine) is a cytidine nucleoside analogue that selectively inhibits DeoxyriboNucleic Acid methyltransferases at low doses, resulting in gene promoter hypomethylation.
Drug3: Decitabine is a cytidine deoxy nucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation.
| Study group | Role | What they receive |
|---|---|---|
| TQB2618 injection | Experimental | TQB2618 injection combined with demethylation drugs, 28 days as a treatment cycle until the disease progresses or the investigator judges that it is not suitable for subject to continue to take medicine. Receives: Drug: TQB2618 injection azacitidine, AZA decitabine, DAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
To evaluate MTD of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Measured: Baseline up to 78 weeks
Dose limited toxicity (DLT)
To evaluate DLT of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Measured: Baseline up to 78 weeks
Recommended Phase II Dose (RP2D)
To evaluate RP2D of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Measured: Baseline up to 78 weeks
Objective Response Rate
To evaluate ORR of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Measured: Baseline up to 78 weeks
Secondary outcomes (6)
Adverse events (AE)
incidence and severity of adverse events (AE)
Measured: Baseline up to 92 weeks
Receptor occupation (RO)
Receptor occupation (RO) of Tim-3 after administration
Measured: Baseline up to 92 weeks
anti-drug antibody (ADA)/ neutralizing antibody (Nab)
Immunogenicity related indicators: the incidence and titer of the subjects' anti-drug antibody (ADA) and the incidence of neutralizing antibody (Nab);
Measured: Baseline up to 92 weeks
Progress Free Survival (PFS) Progress Free Survival (PFS)
Time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Measured: up to 92weeks
Disease control rate (DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 92weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Measured: up to 92weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start29 Apr 2022
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426798
- Sponsor's protocol ID
- TQB2618- I -02
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of TQB2618 Injection in Combination With Demethylation Drugs in Patients With Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT05426798
- Acronym / sponsor ID
- TQB2618- I -02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jun 2022 (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 project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the tolerability and initially evaluate the antitumor efficacy of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2618 injection | Experimental | Drug: TQB2618 injection azacitidine, AZA decitabine, DACTQB2618 injection combined with demethylation drugs, 28 days as a treatment cycle until the disease progresses or the investigator judges that it is not suitable for subject to continue to take medicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1 Subjects with medium-high risk recurrent/refractory International Prognostic Scoring System (IPSS-R) myelodysplastic syndromes(MDS) and acute myelocytic leukemia(AML) clearly diagnosed by pathology, who were intolerant to other medications and judged by the investigator to have no other appropriate treatment.
- 2 ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- 3 The function of main organs is normal.
- 4 Subjects must need to adopt effective methods of contraception.
- 5 Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
Key exclusion criteria (23 listed)
- 1 Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- 2 Patients diagnosed with acute promyelocytic leukemia or Philadelphia Chromosome-Positive Acute Myeloid Leukemia (Ph+AML) , or low-risk relapsed and refractory AML who only received second-line therapy;
- 3 The non-hematologic toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (excluding hair loss).
- 4 Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before treatment.
- 5 The subjects had any history of bleeding or coagulopathy or who were being treated with anticoagulant.
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 |
|---|---|---|
| TQB2618 injection azacitidine, AZA decitabine, DACDrug1: TQB2618 injection is a novel tim-3 inhibitor. Drug2: Azacitidine (5-azacytidine) is a cytidine nucleoside analogue that selectively inhibits DeoxyriboNucleic Acid methyltransferases at low doses, resulting in gene promoter hypomethylation. Drug3: Decitabine is a cytidine deoxy nucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation. | Drug | TQB2618 injection |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 78 weeks
To evaluate MTD of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Dose limited toxicity (DLT)
Time frame: Baseline up to 78 weeks
To evaluate DLT of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Recommended Phase II Dose (RP2D)
Time frame: Baseline up to 78 weeks
To evaluate RP2D of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
Objective Response Rate
Time frame: Baseline up to 78 weeks
To evaluate ORR of TQB2618 injection combined with demethylation drugs in patients with recurrent/refractory acute myeloid leukemia, myelodysplastic syndromes.
6 secondary outcomes
Adverse events (AE)
Time frame: Baseline up to 92 weeks
Receptor occupation (RO)
Time frame: Baseline up to 92 weeks
anti-drug antibody (ADA)/ neutralizing antibody (Nab)
Time frame: Baseline up to 92 weeks
Progress Free Survival (PFS) Progress Free Survival (PFS)
Time frame: up to 92weeks
Disease control rate (DCR)
Time frame: up to 92weeks
Duration of Response (DOR)
Time frame: up to 92weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2618 injection azacitidine, AZA decitabine, DAC in people with Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, run by Chia Tai Tianqing Pharmaceutical Group 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 5 inclusion and 23 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 22 Jun 2022. 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?
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 Yu Wu, Doctor (18980601973, wuyulily@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Baseline up to 78 weeks). The study lists 4 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 22 Jun 2022.