RR DLBCL; PD-1; CD20Phase 2NCT05178836
A Phase II Study to Evaluate the Efficacy and Safety of F520 Combined With F007 in Patients With RR DLBCL
A Phase 2 study testing F520+F007 in people with RR DLBCL; PD-1; CD20, run by Shandong New Time Pharmaceutical Co., LTD.
Trial summary
This is an open-label, single-arm, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of F520 (PD-1) combined with F007(rituximab biosimilar) in patients with Relapsed/Refractory diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- RR DLBCL; PD-1; CD20
- What is being tested?
- F520+F007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Phase 2
- 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
- Aged ≥18 and ≤80 years old.
- CD20-positive relapsed/refractory DLBCL (≥ 2 prior lines of therapy )
- Recurrence: Relapse occurred more than 6 months after the end of treatment. At least one regimen contains Rituximab.
- Refractory: Relapse within 6 months after the end of treatment or fail to reach PR after 2 treatment cycles and fail to reach CR after 4 treatment cycles. At least one regimen contains Rituximab.
- Recurrence after second-line treatment sequential autologous hematopoietic stem cell transplantation.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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- More than 3 months life expectancy.
- Those who agree to provide archived tumor tissue samples or fresh tissue samples
- Biopsy confirmed CD20-positive after the last treatment. Recurrence more than 1 year needs to undergo tissue biopsy to confirm the pathological diagnosis.
- Adequate cardiac function (LVEF≥50%).
- At least one measurable lesion:
- For intranodal lesions, the long diameter should be >1.5cm; for extranodal lesions, the long diameter should be >1.0cm.
- Neutrophil count (NEUT) ≥1.5×109/L and platelet count (PLT) ≥75*109/L and hemoglobin ≥75g/L, total bilirubin level (TBIL) ≤1.5×upper limit of normal (ULN), aspartic acid Aminotransferase (AST), alanine aminotransferase (ALT)≤2.5×ULN, creatinine level (Cr)≤1.5×ULN. Patients with liver metastases (TBIL≤3×ULN, ALT/AST≤5×ULN).
- Signed an informed consent form which was approved by the institutional review board of the respective medical center.
Who cannot join
- Primary mediastinal (thymic) large B-cell lymphoma.
- Transformed lymphoma.
- DLBCL invaded by special parts, such as central nervous system (CNS), testis, breast, ovary, etc.
- High-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangement.
- History of other malignancies (except for basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or breast, superficial bladder cancer, lung carcinoma in situ that have been cured for more than 5 years).
- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV-DNA titer higher than 2000 IU/mL or 1000 copies) or hepatitis C virus (HCV). Treponema pallidum (TP) antibody positive.
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- Received systemic anticancer therapy include radiation, targeted therapy, or any other anticancer therapy within 3weeks or 5 half-lives before the first administration.
- Participation in another clinical trial in the past 4 months.
- Received allogeneic stem cell transplantation.
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody or other medications that stimulates or collaboratively inhibits T cell receptors or CAR-T.
- Usage of immunosuppressive agents, systemic or local hormone therapy within 14 days before the first administration to achieve the purpose of immunosuppression (the daily dose is equivalent to systemic corticosteroids with prednisone> 10 mg).
- Vaccination with an attenuated live vaccine within 4 weeks before the first administration.
- Suffered from interstitial pneumonia in the past 6 months.
- Severe cardiovascular disease (New York Heart Association functional class III or IV, myocardial infarction or unstable arrhythmia or unstable angina in the last 6 months, severe cardiac insufficiency, rogressive multifocal leukoencephalopathy)
- Uncontrolled hypertension (SBP≥180mmHg and/or DBP≥100mmHg).
- Active autoimmune diseases, including but not limited to systemic lupus erythematosus, ankylosing spondylitis, etc.
- Severe mental illness.
- Known hypersensitivity to any of the study drugs or its ingredients.
- Pregnant or lactating women.
- The researcher believes that it is not suitable for enrollment.
About this study
Official title: An Open-label, Single-arm, and Multicenter Phase Ⅱ Study to Evaluate the Efficacay and Safety of F520 Combined With F007 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
This is an open-label, single-arm, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of F520 (PD-1) combined with F007(rituximab biosimilar) in patients with Relapsed/Refractory diffuse large B-cell lymphoma. About 62 patients with relapsed/refractory DLBCL plan to be enrolled in about 8 study sites of the study.
Primary objective:
The purpose is to evaluate the objective response rate of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma.
Secondary objective:
The purpose is to compare the safety of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma.
- Conditions
- RR DLBCL; PD-1; CD20
- Being tested
- F520+F007
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F520+F007Drug
Drug: F007
F007 is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC).
Drug: F520
F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2).
| Study group | Role | What they receive |
|---|---|---|
| F520+F007 | Experimental | Treatment period：
F007 (375 mg/m2) administered intravenously (IV) on Day 1 of each 14-day cycle for 8 cycles.
F520 (200mg) administered intravenously (IV) on Day 2 of each 14-day cycle for cycle 1.
F520 (200mg) administered intravenously (IV) on Day 1 of each 14-day cycle for cycle 2 to 8.
Maintenance period：
F007 (375 mg/m2) administered intravenously (IV) on Day 1 of each 56-day cycle for 10 cycles.
F520 (200mg) administered intravenously (IV) on Day 1/15/29/43 of each 56-day cycle for 10 cycles. Receives: Drug: F520+F007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Objective response rate (ORR)
To evaluate the objective response rate in patients with relapsed or refractory DLBCL.
Measured: 16 weeks
Secondary outcomes (5)
1. Complete response rate (CRR)
CR was defined as the complete disappearance of all previously detectable disease signs. CRR was percentage of participants with a CR event.
Measured: 16 weeks
2. Progression-free survival (PFS)
PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause.
Measured: 2 years
3. Duration of remission (DOR)
The time from the first assessment of complete response or partial response to the first assessment of PD or death.
Measured: 2 years
4. Time to progression (TTP)
TTP was defined as the time from start of treatment to the date of disease progression.
Measured: 2 years
5. Overall survival (OS)
OS defined as the time from start of treatment to the date of death due to any cause.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RR DLBCL; PD-1; CD20Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT05178836
- Sponsor's protocol ID
- NTP-F520-101
- Status last verified
- Dec 2021
- First submitted
- 17 Dec 2021
- Last updated
- 5 Jan 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 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, and Multicenter Phase Ⅱ Study to Evaluate the Efficacay and Safety of F520 Combined With F007 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT05178836
- Acronym / sponsor ID
- NTP-F520-101
- Conditions
- RR DLBCL; PD-1; CD20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Jan 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 is an open-label, single-arm, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of F520 (PD-1) combined with F007(rituximab biosimilar) in patients with Relapsed/Refractory diffuse large B-cell lymphoma. About 62 patients with relapsed/refractory DLBCL plan to be enrolled in about 8 study sites of the study.
Primary objective:
The purpose is to evaluate the objective response rate of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma.
Secondary objective:
The purpose is to compare the safety of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F520+F007 | Experimental | Drug: F520+F007Treatment period： F007 (375 mg/m2) administered intravenously (IV) on Day 1 of each 14-day cycle for 8 cycles. F520 (200mg) administered intravenously (IV) on Day 2 of each 14-day cycle for cycle 1. F520 (200mg) administered intravenously (IV) on Day 1 of each 14-day cycle for cycle 2 to 8. Maintenance period： F007 (375 mg/m2) administered intravenously (IV) on Day 1 of each 56-day cycle for 10 cycles. F520 (200mg) administered intravenously (IV) on Day 1/15/29/43 of each 56-day cycle for 10 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged ≥18 and ≤80 years old.
- CD20-positive relapsed/refractory DLBCL (≥ 2 prior lines of therapy )
- Recurrence: Relapse occurred more than 6 months after the end of treatment. At least one regimen contains Rituximab.
- Refractory: Relapse within 6 months after the end of treatment or fail to reach PR after 2 treatment cycles and fail to reach CR after 4 treatment cycles. At least one regimen contains Rituximab.
- Recurrence after second-line treatment sequential autologous hematopoietic stem cell transplantation.
Key exclusion criteria (20 listed)
- Primary mediastinal (thymic) large B-cell lymphoma.
- Transformed lymphoma.
- DLBCL invaded by special parts, such as central nervous system (CNS), testis, breast, ovary, etc.
- High-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangement.
- History of other malignancies (except for basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or breast, superficial bladder cancer, lung carcinoma in situ that have been cured for more than 5 years).
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 |
|---|---|---|
| F520+F007Drug: F007 F007 is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC). Drug: F520 F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2). | Drug | F520+F007 |
Primary outcome
1. Objective response rate (ORR)
Time frame: 16 weeks
To evaluate the objective response rate in patients with relapsed or refractory DLBCL.
5 secondary outcomes
1. Complete response rate (CRR)
Time frame: 16 weeks
2. Progression-free survival (PFS)
Time frame: 2 years
3. Duration of remission (DOR)
Time frame: 2 years
4. Time to progression (TTP)
Time frame: 2 years
5. Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F520+F007 in people with RR DLBCL; PD-1; CD20, run by Shandong New Time Pharmaceutical Co., LTD.
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 14 inclusion and 20 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 5 Jan 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Objective response rate (ORR) (time frame: 16 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 5 Jan 2022.