Hematological TumorsPhase 1NCT05489276
Clinical Trial of TQB2825 in Subjects With CD20 Positive Hematological Tumors
A Phase 1 study testing TQB2825 injection in people with Hematological Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-group, open, dose escalation and expansion Phase I clinical study, with phase I being a dose escalation study and Phase II being a dose expansion study. The purpose of this study was to evaluate the safety and tolerability of TQB2825 injection in CD20-positive hematological tumor subjects, and to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Tumors
- What is being tested?
- TQB2825 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Malignant hematologic tumors, including but not limited to lymphoma, leukemia, myeloma, etc., which are clearly diagnosed by histology or cytology (report of immunotyping results is required).
- 2 Immunophenotypic analysis showed CD20 positive.
- 3 18 years old ≤ Age ≤75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- 4 Prior induction or salvage therapy ≥second-line treatment, adequate treatment with at least one regimen containing an anti-CD20 mab (combination chemotherapy or monotherapy), and meeting the following criteria:
- Patients who have not been alleviated after the last adequate treatment or whose disease has progressed after remission, or who have relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT)
- Patients with refractory Anti-CD20 monoclonal antibody.
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- 5 According to the 2014 Lugano criteria, there is at least one measurable lesion, that is, a lymph node lesion with a diameter >15 mm or an extranodal lesion with a diameter >10 mm according to the cross-sectional CT image (for tumors with the 2014 Lugano evaluation criteria).
- 6 Negative serum/urine pregnancy test within 7 days prior to initial dosing and must be non-lactating subjects; Female subjects of reproductive age agree to use contraception (such as an intrauterine device, birth control pill, or condom) during the study period and for six months after the study ends; Male subjects agreed to use contraception during the study period and for six months after the end of the study period.
- 7 The subjects voluntarily joined the study and signed informed consent with good compliance.
Who cannot join
- 1 Tumor diseases and medical history:
- Hematologic malignancies that have or are suspected to involve the central nervous system (CNS) or primary CNS lymphoma;
- Subjects who had or currently had other malignancies within 3 years. Two conditions can be included in clinical trials: five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation; Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)];
- Clinically significant uncontrolled pleural effusion ascites requiring repeated drainage and pericardial effusion with medium or higher volume.
- 2 Previous anti-tumor therapy:
- Prior treatment with other antibodies targeting both CD3 and CD20;
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- Received any investigational antibody drug therapy, CAR T therapy, or other immunocytotherapy, or auto-HSCT within 3 months prior to initial administration;
- Prior allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);
- Any major surgery, chemotherapy and/or radiotherapy, immunotherapy or targeted therapy within 4 weeks prior to initial administration;
- The half-life of the first administration is less than 5 drugs from the previous oral targeted therapy (calculated from the end time of the last treatment);
- Received proprietary Chinese medicines with anticancer indications specified in NMPA approved drug instructions within 2 weeks prior to initial administration;
- The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(common terminology criteria for adverse events 5.0) .
- 3 Associated diseases and medical history:
- Liver abnormalities: decompensated cirrhosis and active hepatitis;
- Renal abnormalities:
- Renal failure requiring hemodialysis or peritoneal dialysis; II. Previous history of nephrotic syndrome.
- Gastrointestinal abnormalities:
- Chronic diarrhea persists despite maximum medical treatment; II. Presence of active inflammatory bowel disease within 4 weeks prior to initial administration.
- Cardiovascular and cerebrovascular abnormalities:
- With or prior history of central nervous system diseases; II. MRI evidence of brain inflammation and/or vasculitis; III. Occurrence of cerebrovascular accident or cerebral infarction within 6 months before the first administration; IV. Arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism occurred within 3 months before the first administration; V. With or prior history of cardiovascular disease; VI. Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice); VII. Previous or current heart valvulitis or endocarditis.
- Medical history of immunodeficiency: known human immunodeficiency virus (HIV) infection, or other acquired, congenital immunodeficiency disease;
- Uncontrollable systemic bacterial, fungal or viral infection.
- Lung disease:
- Previous or present with or suspected chronic obstructive pulmonary disease (COPD) and forced expiratory volume at the end of 1 second (FEV1) <60% (estimated value); II. Past or present non-infectious pneumonia requiring corticosteroid treatment; IV. Active tuberculosis.
- History of severe allergies of unknown cause; Known allergy to monoclonal antibodies or to exogenous human immunoglobulin; Known allergy to investigational drug excipients.
- 4 Getting a live-attenuated vaccine within 4 weeks prior to initial administration or during planned study period.
- 5 Participated in clinical trials of other drugs within 30 days.
- 6 It is estimated that the compliance of patients participating in this clinical study is insufficient.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Master, 01088196118, SongYQ_VIP@163.com
About this study
Official title: Phase I Clinical Trial of TQB2825 Injection in Subjects With CD20 Positive Hematological Tumors
This is a single-group, open, dose escalation and expansion Phase I clinical study, with phase I being a dose escalation study and Phase II being a dose expansion study. The purpose of this study was to evaluate the safety and tolerability of TQB2825 injection in CD20-positive hematological tumor subjects, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) (if any), or optimal biological dose (OBD), and recommended phase II dose (RP2D).
- Conditions
- Hematological Tumors
- Being tested
- TQB2825 injection
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2825 injectionDrug
TQB2825 injection is a bi-specific, humanized antibody against CD3×CD20, with the structure ratio of anti-CD3 to anti-CD20 of 1:2. It has two asymmetric Fab ends and a complete Fc end, and is a natural IgG4 subtype with weak antibody-dependent cell-mediated cytotoxicity or complement dependent cytotoxicityfunction. By bridging CD3 and CD20, TQB2825 injection induces T cell activation to promote T cell proliferation/expansion, promote the formation of cytolytic synapses, and cause cytotoxic T cells to release perforin and granase, thereby killing CD20 positive tumor cells. Therefore, TQB2825 injection is intended for the treatment of CD20 positive hematologic tumors, including but not limited to lymphoma, leukemia and myeloma.
| Study group | Role | What they receive |
|---|---|---|
| TQB2825 injection | Experimental | TQB2825 injection is given intravenously every 2 weeks, and every 4 weeks (28 days) as a treatment cycle, with the longest treatment duration not exceeding 2 years. Receives: Drug: TQB2825 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity（DLT）
To evaluate DLT of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
Measured: 104 weeks
the maximum tolerated dose (MTD)
To evaluate MTD of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
Measured: 104 weeks
Recommended Phase II Dose（RP2D)
To evaluate RP2D of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
Measured: 104 weeks
Secondary outcomes (13)
Adverse events (AE)
The occurrence of all adverse events (AE)
Measured: Baseline up to 104 weeks
serious adverse events (SAE)
serious adverse events (SAE)
Measured: Baseline up to 104 weeks
treatment-related adverse events(TRAE)
treatment-related adverse events(TRAE)
Measured: Baseline up to 104 weeks
Elimination half-life (to be used in one-or non- compartmental model) （t1/2)
t1/2 is time that takes for the blood concentration of TQB2825 or metabolite(s) to drop by half.
Measured: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Tmax
Time to reach maximum (peak) plasma concentration following drug administration（Tmax)
Measured: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Maximum (peak) plasma drug concentration （Cmax)
Cmax is the maximum plasma concentration of TQB2825.
Measured: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Area under the plasma concentration-time curve from time zero to time t （AUC0-t)
To characterize the pharmacokinetics of TQB2825 by assessment of area under the plasma concentration time curve from the first dose to the last measurable concentration point.
Measured: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Area under the plasma concentration-time curve from time zero to time ∞（AUC0-∞)
To characterize the pharmacokinetics of TQB2825 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Measured: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Minimum steady-state plasma drug concentration during a dosage interval （Cmin,ss)
Cmin is the minimum plasma concentration of TQB2825
Measured: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Progress Free Survival（PFS)
Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
Measured: up to 96 weeks
Disease control rate（DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Measured: up to 96 weeks
Overall survival (OS)
the time from start of study treatment to date of death due to any cause
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start22 Mar 2022
- Primary completionOct 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 Hematological TumorsStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489276
- Sponsor's protocol ID
- TQB2825- I-01
- Status last verified
- Aug 2022
- First submitted
- 17 Jun 2022
- Last updated
- 5 Aug 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 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of TQB2825 Injection in Subjects With CD20 Positive Hematological Tumors
- ClinicalTrials.gov ID
- NCT05489276
- Acronym / sponsor ID
- TQB2825- I-01
- Conditions
- Hematological Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Aug 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 a single-group, open, dose escalation and expansion Phase I clinical study, with phase I being a dose escalation study and Phase II being a dose expansion study. The purpose of this study was to evaluate the safety and tolerability of TQB2825 injection in CD20-positive hematological tumor subjects, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) (if any), or optimal biological dose (OBD), and recommended phase II dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2825 injection | Experimental | Drug: TQB2825 injectionTQB2825 injection is given intravenously every 2 weeks, and every 4 weeks (28 days) as a treatment cycle, with the longest treatment duration not exceeding 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1 Malignant hematologic tumors, including but not limited to lymphoma, leukemia, myeloma, etc., which are clearly diagnosed by histology or cytology (report of immunotyping results is required).
- 2 Immunophenotypic analysis showed CD20 positive.
- 3 18 years old ≤ Age ≤75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- 4 Prior induction or salvage therapy ≥second-line treatment, adequate treatment with at least one regimen containing an anti-CD20 mab (combination chemotherapy or monotherapy), and meeting the following criteria:
- 5 According to the 2014 Lugano criteria, there is at least one measurable lesion, that is, a lymph node lesion with a diameter >15 mm or an extranodal lesion with a diameter >10 mm according to the cross-sectional CT image (for tumors with the 2014 Lugano evaluation criteria).
Key exclusion criteria (28 listed)
- 1 Tumor diseases and medical history:
- 2 Previous anti-tumor therapy:
- 3 Associated diseases and medical history:
- 4 Getting a live-attenuated vaccine within 4 weeks prior to initial administration or during planned study period.
- 5 Participated in clinical trials of other drugs within 30 days.
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 |
|---|---|---|
| TQB2825 injectionTQB2825 injection is a bi-specific, humanized antibody against CD3×CD20, with the structure ratio of anti-CD3 to anti-CD20 of 1:2. It has two asymmetric Fab ends and a complete Fc end, and is a natural IgG4 subtype with weak antibody-dependent cell-mediated cytotoxicity or complement dependent cytotoxicityfunction. By bridging CD3 and CD20, TQB2825 injection induces T cell activation to promote T cell proliferation/expansion, promote the formation of cytolytic synapses, and cause cytotoxic T cells to release perforin and granase, thereby killing CD20 positive tumor cells. Therefore, TQB2825 injection is intended for the treatment of CD20 positive hematologic tumors, including but not limited to lymphoma, leukemia and myeloma. | Drug | TQB2825 injection |
Primary outcome
Dose limiting toxicity（DLT）
Time frame: 104 weeks
To evaluate DLT of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
the maximum tolerated dose (MTD)
Time frame: 104 weeks
To evaluate MTD of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
Recommended Phase II Dose（RP2D)
Time frame: 104 weeks
To evaluate RP2D of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
13 secondary outcomes
Adverse events (AE)
Time frame: Baseline up to 104 weeks
serious adverse events (SAE)
Time frame: Baseline up to 104 weeks
treatment-related adverse events(TRAE)
Time frame: Baseline up to 104 weeks
Elimination half-life (to be used in one-or non- compartmental model) （t1/2)
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Tmax
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Maximum (peak) plasma drug concentration （Cmax)
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Area under the plasma concentration-time curve from time zero to time t （AUC0-t)
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Area under the plasma concentration-time curve from time zero to time ∞（AUC0-∞)
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Minimum steady-state plasma drug concentration during a dosage interval （Cmin,ss)
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Progress Free Survival（PFS)
Time frame: up to 96 weeks
Disease control rate（DCR)
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Overall survival (OS)
Time frame: up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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 TQB2825 injection in people with Hematological Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin 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 9 inclusion and 28 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 Aug 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 Yuqin Song, Master (010-88196118, SongYQ_VIP@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity（DLT） (time frame: 104 weeks). 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 5 Aug 2022.