Relapsed/Refractory LymphomaPhase 1NCT05293028
Study of F527 in Patients With Relapsed or Refractory Lymphoma
A Phase 1 study testing F527 in people with Relapsed/Refractory Lymphoma, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
This study is a non-randomized, open-label, phase I dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, PK and immunogen of F527 in patients with relapsed or refractory lymphoma sexual characteristics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapsed/Refractory Lymphoma
- What is being tested?
- F527
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 20 May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 and ≤80 years old;
- Patients with histopathologically confirmed relapsed/refractory lymphoma; relapsed/refractory was defined as a patient who did not achieve a response (including complete or partial response) after the last systemic therapy regimen, or had disease progression after achieving a response or relapse;
- Subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node>15mm, long diameter of extranodal lesion>10mm);
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
- Expected survival period ≥ 3 months;
- The function of vital organs meets the following requirements (do not use any blood components and cytokines within 7 days before the first dose):
- Blood routine: neutrophil count ≥1.5×109/L; platelet count ≥75×109/L; hemoglobin ≥95g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: creatinine≤1.5×ULN; Coagulation function: International Normalized Ratio (INR)≤1.5×ULN and Activated Partial Thromboplastin Time (APTT)≤1.5×ULN;
- Understand the test procedures and content, and sign the informed consent voluntarily.
Who cannot join
- Special types of lymphoma such as primary/secondary central nervous system lymphoma, etc.;
- Patients with a history of other malignant tumors within the past 5 years, except for locally curable cancers (such as basal cell or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc.);
- History of hemolytic anemia or Evans syndrome in the last three months;
- Positive direct antiglobulin test;
- Those who have used CD47-targeted drugs or signal-regulated protein alpha (SIRPα)-targeted drugs in the past;
- Received anti-tumor-related treatments such as anti-tumor chemotherapy, radiotherapy, biological therapy, or immunotherapy/immunomodulation therapy within 2 weeks before the first administration; the toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except for alopecia);
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- Patients who have a history of organ transplantation or allogeneic bone marrow transplantation, or who have received autologous stem cell transplantation within 3 months before the first administration or have other severe immunodeficiency;
- HIV positive patients, syphilis-infected patients (RPR positive and TPPA positive) or active hepatitis (HBsAg positive and/or HBcAb positive, and HBV-DNA positive or higher than the upper limit of normal; HCV antibody positive and HCV- RNA positive or above the upper limit of normal);
- Patients with uncontrollable or severe cardiovascular disease, who have New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases within 6 months before the first administration; Uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
- Patients who have received any other clinical trial drug treatment within 4 weeks before the first dose;
- Patients who have received live attenuated vaccine within 4 weeks before the first dose;
- Patients who have a history of severe allergies, or who are known to be allergic to macromolecular protein preparations/monoclonal antibodies and any components of the investigational drug;
- Patients with a history of mental illness or drug abuse;
- Pregnant or lactating women, female patients or male patient partners who plan to become pregnant during the study period to 6 months after the last dose, and are reluctant to use a medically recognized effective contraceptive method (such as an intrauterine device or an intrauterine device) during the trial. condoms);
- Patients who are judged by the investigator to be unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Weili Zhao
About this study
Official title: Phase I Clinical Study of Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of F527 in the Treatment of Patients With Relapsed or Refractory Lymphoma
This study is a non-randomized, open-label, phase I dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, PK and immunogen of F527 in patients with relapsed or refractory lymphoma sexual characteristics.
- Conditions
- Relapsed/Refractory Lymphoma
- Being tested
- F527
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F527Drug
0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW
| Study group | Role | What they receive |
|---|---|---|
| Drug:F527 | Experimental | F527 is dose-escalated sequentially by accelerated titration and i3+3 design. Receives: Drug: F527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Measured: Up to 21 days
Maximum Tolerated Dose (MTD)
Maximum Tolerated Dose
Measured: Up to 21 days
RP2D
PR2D will be determined by the sponsor and investigator based on the comprehensive data obtained on drug safety and tolerability, PK, preliminary anti-tumor efficacy, etc.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start20 May 2022 (estimated)
- Primary completion20 Nov 2023 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory LymphomaStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293028
- Sponsor's protocol ID
- NTP-F527-001
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 23 Mar 2022
- 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of F527 in the Treatment of Patients With Relapsed or Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT05293028
- Acronym / sponsor ID
- NTP-F527-001
- Conditions
- Relapsed/Refractory Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 23 Mar 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 study is a non-randomized, open-label, phase I dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, PK and immunogen of F527 in patients with relapsed or refractory lymphoma sexual characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug:F527 | Experimental | Drug: F527F527 is dose-escalated sequentially by accelerated titration and i3+3 design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged ≥18 and ≤80 years old;
- Patients with histopathologically confirmed relapsed/refractory lymphoma; relapsed/refractory was defined as a patient who did not achieve a response (including complete or partial response) after the last systemic therapy regimen, or had disease progression after achieving a response or relapse;
- Subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node>15mm, long diameter of extranodal lesion>10mm);
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
- Expected survival period ≥ 3 months;
Key exclusion criteria (15 listed)
- Special types of lymphoma such as primary/secondary central nervous system lymphoma, etc.;
- Patients with a history of other malignant tumors within the past 5 years, except for locally curable cancers (such as basal cell or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc.);
- History of hemolytic anemia or Evans syndrome in the last three months;
- Positive direct antiglobulin test;
- Those who have used CD47-targeted drugs or signal-regulated protein alpha (SIRPα)-targeted drugs in the past;
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 |
|---|---|---|
| F5270.001、0.01、0.1、0.3、1、3 and10 mg/kg QW | Drug | Drug:F527 |
Primary outcome
DLTs
Time frame: Up to 21 days
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Maximum Tolerated Dose (MTD)
Time frame: Up to 21 days
Maximum Tolerated Dose
RP2D
Time frame: Up to 21 days
PR2D will be determined by the sponsor and investigator based on the comprehensive data obtained on drug safety and tolerability, PK, preliminary anti-tumor efficacy, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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 F527 in people with Relapsed/Refractory Lymphoma, run by Shandong New Time Pharmaceutical 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 8 inclusion and 15 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 23 Mar 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 Shaohong Yin (86-15265901803, yinshaohong@lunan.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (time frame: Up to 21 days). 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?
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 23 Mar 2022.