Non-Hodgkin's LymphomaPhase 1NCT04152148

A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients

A Phase 1 study testing 500mg BAT4306F, 750mg BAT4306F and 900mg BAT4306F in people with Non-Hodgkin's Lymphoma, run by Bio-Thera Solutions at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-Hodgkin's Lymphoma
What is being tested?: 500mg BAT4306F, 750mg BAT4306F and 900mg BAT4306F
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteChina
Study dates: 4 Sep 2018to 13 Jan 2021
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To be eligible for study entry subjects must satisfy all of the following criteria: 1. Must be willing to provide written consent 2. Male or female, 18 years old or older 3. Histopathology test confirmed CD20-positive patients with relapsed/refractory/progressive non-Hodgkin's lymphoma, who have been treated with at least one course of standard anti-tumor regimen; 4. Has at least one measurable lesion: CLL patient monoclonal B cells≥5x 10^9/L. IgM in WM patients is greater than 2 times of the upper limit of normal. In patients other than CLL and WM, any diameter of the lymph node lesion ≥1.5cm or any extranodal lesion >1cm; 5. If the previous radiotherapy and chemotherapy cause toxic side effects, it needs to be restored to at least level 1 or returned to the baseline value or to be judged as irreversible (except for neurotoxicity related to grade 2 alopecia or platinum-containing treatment); 6. The patient's ECOG score was 0-2 points; 7. Expected survival is at least 6 months; 8. Subjects must have appropriate organ function and meet all of the following laboratory findings prior to enrollment: 1) The bone marrow reserve was basically normal: neutrophils (ANC) ≥ 1.0 × 10^9/L, hemoglobin (HB) ≥ 70 g/L, platelets (PLT) ≥ 50×10^9/L (Except for bone marrow invasion, B-NHL-related autoimmune cytopenia. bone marrow invasion will be judged by bone marrow biopsy, bone marrow smear, and bone marrow flow cytology results.) 2) Liver function is basically normal: ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN, TBIL ≤ 1.5×ULN (except for liver invasion. Patients with B-NHL-related autoimmune hemolytic anemia, TBIL is not subject to this limit); 3) Renal function is basically normal: creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60mL/min; 4) The conventional coagulation examinations is basically normal: INR ≤ 1.5×ULN, APTT does not exceed the normal reference for 10 seconds; 9. Fertile female must be tested negative for serum pregnancy test; 10. If the patient is a male, it must be a male who has undergone surgical birth control, or use of an effective contraceptive method during the study period and within 12 months after the study drug is discontinued. In the case of female, an effective contraceptive procedure must be taken or during menopause or use of an effective contraceptive method during the study period and within 12 months of the study drug discontinuation, and avoid breastfeeding during the study period and within 12 months of the study drug discontinuation.

Who cannot join

Subjects will be excluded from the study if one or more of the following criteria are applicable: 1. Treatment with any monoclonal antibody within 3 months prior to the first dose; 2. Have used any anti-cancer vaccine in the past, or have used the HPV vaccine within 3 months prior to the study; 3. Used anti-CD20 mAb within 3 months prior to the first dose; 4. Radioimmunotherapy was used within 3 months prior to the first dose; 5. Treatment of transfusion, erythropoietin, granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor within 2 weeks prior to the first dose; 6. Hematopoietic stem cell transplantation was performed 3 months before the first administration or hematopoietic stem cell transplantation was planned in 3 months; 7. A history of severe allergic reactions to humanized or murine monoclonal antibodies. (or is high reactivity / allergy to murine-derived products); 8. Evidence or medical history of central nervous system invasion or cranial neuropathy; 9. Concurrent with other malignant tumors (except for in situ cervical cancer, skin cancer, complete remission > 5 years of breast cancer and melanoma); 10. Other serious, uncontrollable concomitant diseases, including but not limited to: active infections, uncontrolled diabetes, uncontrollable hypertension, etc.; 11. Major surgery performed within 4 weeks prior to the first dose or during the expected study period, or if the surgical wound is not healed; 12. Patients with rheumatoid arthritis, granulomatous vasculitis, microscopic polyangiitis, toxic epidermal necrolysis or Stevens-Johnson syndrome; 13. Patients with chronic idiopathic bowel disease (including history of Crohns disease and Ulcerative Colitis), with intestinal obstruction or with chronic diarrhea; 14. Other past history, acute or chronic disease, mental illness, or laboratory test abnormalities that may result in increased risk of involvement in study or study drug administration, or interference in interpretation of research findings; 15. Pregnant or lactating women; 16. Received treatment in another clinical study within 4 weeks prior to the first dose; 17. Patients receiving high-dose corticosteroids (prednisolone greater than 10 mg/day or equivalent dosage of other drugs for 2 weeks or more) within 4 weeks prior to the first dose; 18. Virological examination: HBsAg positive; HBcAb positive and HBV-DNA detection ≥ detection upper limit; HCV antibody positive; HIV antibody positive; syphilis infection positive. 19. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100089

Other trials in China

About this study

Official title: A Phase I Clinical Trial of BAT4306F (for Injection) on Safety, Tolerability and Pharmacokinetics for Patients With CD20-positive, B-cell Non-Hodgkin's Lymphoma

The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma

Read the detailed description

The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma, when the injection dosage escalates, to ultimately determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended dosage for phase II clinical studies ( RP2D);
To evaluate the pharmacokinetics (PK) of BAT4306F(for injection);
To evaluate the immunogenicity profile of BAT4306F(for injection);
To evaluate the efficacy profile of BAT4306F (for injection);Using the Lugano criteria (2014), the 2008 IWCLL efficacy evaluation criteria, and the 2014 IWWM-7 efficacy evaluation criteria were used to evaluate the efficacy of related diseases at week 7, week 13, and week 19. The index of evaluation was ORR (including CR, PR, SD and PD, ORR is the proportion of patients with CR and PR).

Conditions: Non-Hodgkin's Lymphoma
Being tested: 500mg BAT4306F, 750mg BAT4306F, 900mg BAT4306F, 1000mg BAT4306F
Medical subject headings: Lymphoma, Non-Hodgkin

What participants receive

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

500mg BAT4306FBiological
Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
750mg BAT4306FBiological
Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
900mg BAT4306FBiological
Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
1000mg BAT4306FBiological
Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result

Study groups in NCT04152148
Study group	Role	What they receive
500mg BAT4306F	Experimental	3 weeks of a cycle Receives: Biological: 500mg BAT4306F
750mg BAT4306F	Experimental	3 weeks of a cycle Receives: Biological: 750mg BAT4306F
900mg BAT4306F	Experimental	3 weeks of a cycle Receives: Biological: 900mg BAT4306F
1000mg BAT4306F	Experimental	3 weeks of a cycle Receives: Biological: 1000mg BAT4306F

What is being measured

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

Dose-limiting toxicity（DLT）
Safety and tolerability endpoint
Measured: 4 weeks
Maximum tolerated dosed (MTD)
Safety and tolerability endpoint
Measured: 4weeks
pharmacokinetics (PK)
evaluate the pharmacokinetics (PK) of Recombinant Glycosylation-modified Anti-human-CD20 Monoclonal Antibody Solution for injection
Measured: up to 154 Days
CD19+ B lymphocyte ratio
Pharmacodynamics endpoint
Measured: up to 154 Days
anti drug antibodies (ADA)
Plasma level of anti drug antibodies (ADA) and neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level
Measured: up to 154 Days
ORR
Overall response rate
Measured: the 7th week,the 13th week,the 19th week

Timeline

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

4 Sep 201813 Jan 2021

First posted5 Nov 2019
Study start4 Sep 2018
Primary completion13 Jan 2021
Study completion13 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Hodgkin's LymphomaStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04152148
Sponsor's protocol ID: BAT4306F-001-CR
Status last verified: Feb 2023
First submitted: 30 Oct 2019
Last updated: 8 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial of BAT4306F (for Injection) on Safety, Tolerability and Pharmacokinetics for Patients With CD20-positive, B-cell Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT04152148
Acronym / sponsor ID: BAT4306F-001-CR
Conditions: Non-Hodgkin's Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Bio-Thera SolutionsIndustry (pharma, biotech, devices)
Study start: 4 Sep 2018 (actual)
Primary completion: 13 Jan 2021 (actual)
Study completion: 13 Jan 2021 (actual)
First posted: 5 Nov 2019 (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.

The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma

Detailed description

The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma, when the injection dosage escalates, to ultimately determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended dosage for phase II clinical studies ( RP2D);
To evaluate the pharmacokinetics (PK) of BAT4306F(for injection);
To evaluate the immunogenicity profile of BAT4306F(for injection);
To evaluate the efficacy profile of BAT4306F (for injection);Using the Lugano criteria (2014), the 2008 IWCLL efficacy evaluation criteria, and the 2014 IWWM-7 efficacy evaluation criteria were used to evaluate the efficacy of related diseases at week 7, week 13, and week 19. The index of evaluation was ORR (including CR, PR, SD and PD, ORR is the proportion of patients with CR and PR).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
500mg BAT4306F	Experimental	Biological: 500mg BAT4306F3 weeks of a cycle
750mg BAT4306F	Experimental	Biological: 750mg BAT4306F3 weeks of a cycle
900mg BAT4306F	Experimental	Biological: 900mg BAT4306F3 weeks of a cycle
1000mg BAT4306F	Experimental	Biological: 1000mg BAT4306F3 weeks of a cycle

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

To be eligible for study entry subjects must satisfy all of the following criteria: 1. Must be willing to provide written consent 2. Male or female, 18 years old or older 3. Histopathology test confirmed CD20-positive patients with relapsed/refractory/progressive non-Hodgkin's lymphoma, who have been treated with at least one course of standard anti-tumor regimen; 4. Has at least one measurable lesion: CLL patient monoclonal B cells≥5x 10^9/L. IgM in WM patients is greater than 2 times of the upper limit of normal. In patients other than CLL and WM, any diameter of the lymph node lesion ≥1.5cm or any extranodal lesion >1cm; 5. If the previous radiotherapy and chemotherapy cause toxic side effects, it needs to be restored to at least level 1 or returned to the baseline value or to be judged as irreversible (except for neurotoxicity related to grade 2 alopecia or platinum-containing treatment); 6. The patient's ECOG score was 0-2 points; 7. Expected survival is at least 6 months; 8. Subjects must have appropriate organ function and meet all of the following laboratory findings prior to enrollment: 1) The bone marrow reserve was basically normal: neutrophils (ANC) ≥ 1.0 × 10^9/L, hemoglobin (HB) ≥ 70 g/L, platelets (PLT) ≥ 50×10^9/L (Except for bone marrow invasion, B-NHL-related autoimmune cytopenia. bone marrow invasion will be judged by bone marrow biopsy, bone marrow smear, and bone marrow flow cytology results.) 2) Liver function is basically normal: ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN, TBIL ≤ 1.5×ULN (except for liver invasion. Patients with B-NHL-related autoimmune hemolytic anemia, TBIL is not subject to this limit); 3) Renal function is basically normal: creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60mL/min; 4) The conventional coagulation examinations is basically normal: INR ≤ 1.5×ULN, APTT does not exceed the normal reference for 10 seconds; 9. Fertile female must be tested negative for serum pregnancy test; 10. If the patient is a male, it must be a male who has undergone surgical birth control, or use of an effective contraceptive method during the study period and within 12 months after the study drug is discontinued. In the case of female, an effective contraceptive procedure must be taken or during menopause or use of an effective contraceptive method during the study period and within 12 months of the study drug discontinuation, and avoid breastfeeding during the study period and within 12 months of the study drug discontinuation.

Key exclusion criteria (1 listed)

Subjects will be excluded from the study if one or more of the following criteria are applicable: 1. Treatment with any monoclonal antibody within 3 months prior to the first dose; 2. Have used any anti-cancer vaccine in the past, or have used the HPV vaccine within 3 months prior to the study; 3. Used anti-CD20 mAb within 3 months prior to the first dose; 4. Radioimmunotherapy was used within 3 months prior to the first dose; 5. Treatment of transfusion, erythropoietin, granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor within 2 weeks prior to the first dose; 6. Hematopoietic stem cell transplantation was performed 3 months before the first administration or hematopoietic stem cell transplantation was planned in 3 months; 7. A history of severe allergic reactions to humanized or murine monoclonal antibodies. (or is high reactivity / allergy to murine-derived products); 8. Evidence or medical history of central nervous system invasion or cranial neuropathy; 9. Concurrent with other malignant tumors (except for in situ cervical cancer, skin cancer, complete remission > 5 years of breast cancer and melanoma); 10. Other serious, uncontrollable concomitant diseases, including but not limited to: active infections, uncontrolled diabetes, uncontrollable hypertension, etc.; 11. Major surgery performed within 4 weeks prior to the first dose or during the expected study period, or if the surgical wound is not healed; 12. Patients with rheumatoid arthritis, granulomatous vasculitis, microscopic polyangiitis, toxic epidermal necrolysis or Stevens-Johnson syndrome; 13. Patients with chronic idiopathic bowel disease (including history of Crohns disease and Ulcerative Colitis), with intestinal obstruction or with chronic diarrhea; 14. Other past history, acute or chronic disease, mental illness, or laboratory test abnormalities that may result in increased risk of involvement in study or study drug administration, or interference in interpretation of research findings; 15. Pregnant or lactating women; 16. Received treatment in another clinical study within 4 weeks prior to the first dose; 17. Patients receiving high-dose corticosteroids (prednisolone greater than 10 mg/day or equivalent dosage of other drugs for 2 weeks or more) within 4 weeks prior to the first dose; 18. Virological examination: HBsAg positive; HBcAb positive and HBV-DNA detection ≥ detection upper limit; HCV antibody positive; HIV antibody positive; syphilis infection positive. 19. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

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
500mg BAT4306FPhase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result	Biological	500mg BAT4306F
750mg BAT4306FPhase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result	Biological	750mg BAT4306F
900mg BAT4306FPhase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result	Biological	900mg BAT4306F
1000mg BAT4306FPhase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result	Biological	1000mg BAT4306F

Primary outcome

Dose-limiting toxicity（DLT）
Time frame: 4 weeks
Safety and tolerability endpoint
Maximum tolerated dosed (MTD)
Time frame: 4weeks
Safety and tolerability endpoint
pharmacokinetics (PK)
Time frame: up to 154 Days
evaluate the pharmacokinetics (PK) of Recombinant Glycosylation-modified Anti-human-CD20 Monoclonal Antibody Solution for injection
CD19+ B lymphocyte ratio
Time frame: up to 154 Days
Pharmacodynamics endpoint
anti drug antibodies (ADA)
Time frame: up to 154 Days
Plasma level of anti drug antibodies (ADA) and neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level
ORR
Time frame: the 7th week,the 13th week,the 19th week
Overall response rate

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Individual participant dataSharing planned: Undecided

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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.

Yuqin Song, investigator principal investigator

Peking University Cancer Hospital & Institute

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 500mg BAT4306F, 750mg BAT4306F and 900mg BAT4306F in people with Non-Hodgkin's Lymphoma, run by Bio-Thera Solutions 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose-limiting toxicity（DLT） (time frame: 4 weeks). The study lists 6 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 NCT04152148.

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 8 Feb 2023.