Hematologic MalignancyPhase 1NCT05690425
A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML
A Phase 1 study testing BC3402 Injection in people with Hematologic Malignancy, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.
Trial summary
This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose. The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- BC3402 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2023to 15 Jun 2024
- 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
- The subject must be able to understand and voluntarily sign the informed consent form;
- Subjects were 18 years old or above when they signed the informed consent form;
- Subjects mast be willing to undergo serial bone marrow aspirate procedures on the study;
- Morphologically confirmed diagnosis as extremely low risk, low risk, intermediate risk, high risk, extremely high risk MDS (IPSS-R classification) or CMML according to WHO (2016) diagnostic criteria, and WBC<13* 10^9/L (allowed to receive hydroxyurea or leukocyte removal before enrollment to reduce WBC count), and:
- 4.1 According to IPSS-R, patients diagnosis as extremely low risk, low risk or intermediate risk MDS must meet one or more of the following criteria:
- Patients who are RBCs and/or platelets transfusion-dependent , must receive stable infusion 2U/month above for 3 months before the first dose;
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- Patients who are RBCs transfusion-dependent must Erythropoiesis stimulating agents (ESAs) failure or intolerant ;
- Patients who are RBCs transfusion-dependent without ESA treatment mast have serum erythropoietin level >500 U/L ;
- MDS patients with isolated del (5q) ("5q syndrome") must have disease progression or intolerance during lenalidomide treatment;
- Platelet transfusion dependent patients must be treated with thrombopoietin receptor agonist (TPO-RA) for relapse/refractory or intolerance;
- Persistent (>3 months) neutrophil absolute count is lower than 1.5 before screening × 10^9/L；
- 4.2 MDS and CMML patients rated as high-risk or extremely high-risk according to IPSS-R:
- The monotherapy of demethylated drugs (HMA) failed (4 cycles of decitabine treatment or 6 cycles of azacytidine treatment) or was not tolerated;
- Not suitable for intensive treatment;
- CMML patients must fail or not tolerate at least one previous treatment (including but not limited to hydroxyurea treatment, HMA treatment, etc.);
- 5. Patient has an Eastern Cooperative Oncology Group(ecog) status between 0 and1;
- 6. Expected survival time > 3 months;
- 7. White blood cell count (WBC) ≤ 25 × 103/μL within 7 days prior to the first dose (hydroxycarbamide or leukapheresis is allowed to meet this criterion)
- 8. Platelet > 30 × 10^9/L before screening；
- 9. Adequate renal function:
- Serum creatinine ≤ 1.5 × Upper limit of normal value (ULN), and creatinine clearance ≥ 45 mL/min; If the urine protein is qualitative ≥ 2+, the 24-hour urine protein quantity shall be less than 3.5g;
- 10. Adequate liver function:
- Total serum bilirubin ≤ 1.5 × ULN (except Gilbert syndrome, this kind of subjects only meet the requirements of direct bilirubin ≤ 1.5 × ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN；
- 11. When screening, serum or urine pregnancy test (for female patients with fertility) was negative;
- 12. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and be willing to undergo a bone marrow aspirate and/biopsy at screening, during and at the end of therapy on this study.
- 13. Male and female patients with fertility must agree to use medically approved contraceptive methods throughout the study period and continue to use them until 6 months after the last treatment of BC3402.
Who cannot join
- Suitable and willing to accept hematopoietic stem cell transplantation (allogeneic or autologous);
- Immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., were used within 2 weeks before the first use of the test drug;
- 3. Prior treatment with immunomodulatory agents including but not limited to thymosin, interleukin-2, and interferon within 2 weeks prior to the first dose of study drugs.
- Patients who have used any Chinese herbal medicine or traditional Chinese medicine with anti-tumor activity within 2 weeks prior to the first dose of study drugs.
- Patients who received live attenuated vaccine within 4 weeks prior to the first dose of study drug.
- Prior treatment with an investigational drug within 4 weeks or 5 half-lives of the agent (whichever is longer) before the planned first dose of study drug. The washout period for biologic agents should be 28 days since the last dose.
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- Prior exposure to TIM-3 targeted therapy at any time.
- Participants receiving chemotherapy within 14 days or 5 half lives (whichever is longer) before the first dose of study treatment;
- Major organ surgery or significant trauma or radiotherapy within 2 weeks before entering the study;
- Have received systemic glucocorticoid (prednisone>10mg/day or equivalent dose of the same drug) or other immunosuppressive drugs within 2 weeks before the first use of the study drug;
- Active infections or other severe infections requiring systemic antibiotics, antiviral or antifungal drugs within 2 weeks before the first administration of the study treatment. Except for those who are treated with anti infection prevention according to local guidelines or the judgment of the researcher.
- Known malignant tumors in progress or requiring active treatment in the past 5 years (except those diagnosed in the study). The exceptions to this exclusion criterion are as follows: basal cell carcinoma and squamous cell skin carcinoma completely resected; And completely resected carcinoma in situ of any type;
- Active hepatitis B or C, history of HIV infection, active syphilis;
- Patients with autoimmune diseases;
- Known uncontrolled central nervous system (CNS) involvement;
- Patients with history of serious cardiovascular and cerebrovascular diseases, including but not limited to, (1)Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, Ⅱ - Ⅲ degree atrioventricular block ect.
- During the screening period, 12 lead electrocardiogram (ECG) was measured for three times in the research center. According to the average value of the three times calculated by the QTc formula of the instrument used in the center, QTc interval> 470ms; (3) occurrence of acute coronary heart failure, acute congestive syndrome, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events within 6 months prior to the first dose of study drug (4) Patients with history of New York Heart Society (NYHA) class≥ II, or left ventricular ejection fraction (LVEF) < 50%; (5) Clinically uncontrollable hypertension
- 17. Mental disorders or poor compliance; 18. Patients who are being pregnant or breastfeeding. 19.Patients with other serious systemic diseases or conditions who are deemed unsuitable to participate in this clinical study at the judgement of the Investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Hui Zeng, Prof, 18002201919, androps2011@hotmail.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BC3402 as a Single Agent in Patients With Myelodysplastic Syndrome SYNDR(MDS) and Chronic Myelomonocytic Leukemia(CMML)
This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose.
The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks).
A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study.
Read the detailed description
This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose.
The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks). The Cohort1 will be enrolled 1 patient initially.If this subject experience any Grade 2 or higher toxicity during the first cycle, unless definitely unrelated to BC3402,2 more patients will be accrued,and the standard "3+3" dose escalation algorithm will be followed thereafter , with each cohort enrolling 3 to 6 subjects. Cohorts 2 and 3 will follow the traditional 3+3 dose escalation design. Dose limiting toxicities will be assessed during the first cycle(i.e., total21 days). If ≥ 2 subjects experience a DLT at a given dose level, the MTD would have been exceeded, further dose escalation is not pursued, and the prior dose level is expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD.
A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study.
- Conditions
- Hematologic Malignancy
- Being tested
- BC3402 Injection
- Keywords
- MDS and CMML
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC3402 InjectionDrug
Also called not have
Subjects will receive BC3402 as a single agent via intravenous infusion once every 3-weeks (Q3W),the dose of BC3402 was calculated according to the dose group and body weight of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| BC3402 treatment group | Experimental | BC3402 as a single agent via intravenous infusion once every 3-weeks Receives: Drug: BC3402 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities(DLTs) within 28 days (first cycle)
The DLT for this study will be evaluated in the first cycle. The DLT will include any of the following adverse events that cannot be clearly attributed to other reasons and are judged to be related to BC3402.
- Hematologic toxicity in the following cases: Hematologic toxicity ≥ grade 4 occurred in the first cycle, which could not be recovered to baseline value within 21 days after the occurrence, and bone marrow primordial cells<5%.
- Non hematologic toxicities:
- Grade 2 above ALT and/or AST elevational concomitant grade 2 total bilirubin elevation(non biliary obstruction or other reasons);
- QTcF interval > 470 ms or longer than baseline > 60 ms;
- Grade 3 or above non-haematological toxicity;
- Others Any ongoing toxicity (of any grade) not caused by disease progression that results in a delay of more than 2 weeks in the next scheduled cycle;
Measured: Dose limiting toxicities (DLT) will be assessed during the first cycle (i.e., total 3 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start6 Jul 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- hui zeng, prof, Principal investigator, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690425
- Sponsor's protocol ID
- BC3402-002
- Status last verified
- Jul 2023
- First submitted
- 10 Jan 2023
- Last updated
- 24 Jul 2023
- 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 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BC3402 as a Single Agent in Patients With Myelodysplastic Syndrome SYNDR(MDS) and Chronic Myelomonocytic Leukemia(CMML)
- ClinicalTrials.gov ID
- NCT05690425
- Acronym / sponsor ID
- BC3402-002
- Conditions
- Hematologic Malignancy
- Keywords
- MDS and CMML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 19 Jan 2023 (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 a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose.
The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks).
A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study.
Detailed description
This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose.
The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks). The Cohort1 will be enrolled 1 patient initially.If this subject experience any Grade 2 or higher toxicity during the first cycle, unless definitely unrelated to BC3402,2 more patients will be accrued,and the standard "3+3" dose escalation algorithm will be followed thereafter , with each cohort enrolling 3 to 6 subjects. Cohorts 2 and 3 will follow the traditional 3+3 dose escalation design. Dose limiting toxicities will be assessed during the first cycle(i.e., total21 days). If ≥ 2 subjects experience a DLT at a given dose level, the MTD would have been exceeded, further dose escalation is not pursued, and the prior dose level is expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD.
A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BC3402 treatment group | Experimental | Drug: BC3402 InjectionBC3402 as a single agent via intravenous infusion once every 3-weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- The subject must be able to understand and voluntarily sign the informed consent form;
- Subjects were 18 years old or above when they signed the informed consent form;
- Subjects mast be willing to undergo serial bone marrow aspirate procedures on the study;
- Morphologically confirmed diagnosis as extremely low risk, low risk, intermediate risk, high risk, extremely high risk MDS (IPSS-R classification) or CMML according to WHO (2016) diagnostic criteria, and WBC<13* 10^9/L (allowed to receive hydroxyurea or leukocyte removal before enrollment to reduce WBC count), and:
- 4.1 According to IPSS-R, patients diagnosis as extremely low risk, low risk or intermediate risk MDS must meet one or more of the following criteria:
Key exclusion criteria (18 listed)
- Suitable and willing to accept hematopoietic stem cell transplantation (allogeneic or autologous);
- Immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., were used within 2 weeks before the first use of the test drug;
- 3. Prior treatment with immunomodulatory agents including but not limited to thymosin, interleukin-2, and interferon within 2 weeks prior to the first dose of study drugs.
- Patients who have used any Chinese herbal medicine or traditional Chinese medicine with anti-tumor activity within 2 weeks prior to the first dose of study drugs.
- Patients who received live attenuated vaccine within 4 weeks prior to the first dose of study drug.
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 |
|---|---|---|
| BC3402 InjectionAlso: not haveSubjects will receive BC3402 as a single agent via intravenous infusion once every 3-weeks (Q3W),the dose of BC3402 was calculated according to the dose group and body weight of the subjects. | Drug | BC3402 treatment group |
Primary outcome
Incidence of dose limiting toxicities(DLTs) within 28 days (first cycle)
Time frame: Dose limiting toxicities (DLT) will be assessed during the first cycle (i.e., total 3 weeks).
The DLT for this study will be evaluated in the first cycle. The DLT will include any of the following adverse events that cannot be clearly attributed to other reasons and are judged to be related to BC3402. 1. Hematologic toxicity in the following cases: Hematologic toxicity ≥ grade 4 occurred in the first cycle, which could not be recovered to baseline value within 21 days after the occurrence, and bone marrow primordial cells<5%. 2. Non hematologic toxicities: * Grade 2 above ALT and/or AST elevational concomitant grade 2 total bilirubin elevation(non biliary obstruction or other reasons); * QTcF interval > 470 ms or longer than baseline > 60 ms; * Grade 3 or above non-haematological toxicity; 3. Others Any ongoing toxicity (of any grade) not caused by disease progression that results in a delay of more than 2 weeks in the next scheduled cycle;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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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.
hui zeng, prof principal investigator
First Affiliated Hospital of Jinan University
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 BC3402 Injection in people with Hematologic Malignancy, run by Biocity Biopharmaceutics 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 27 inclusion and 18 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 24 Jul 2023. 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 hui zeng, prof (18002201919, xyzengh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities(DLTs) within 28 days (first cycle) (time frame: Dose limiting toxicities (DLT) will be assessed during the first cycle (i.e., total 3 weeks).). 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 Jul 2023.