CD20-positive Hematological MalignanciesPhase 1NCT07110194
Phase I Clinical Trial of TQB2825 Subcutaneous Injection in CD20-positive Hematological Malignancies
A Phase 1 study testing TQB2825 Injection (Subcutaneous Injection) in people with CD20-positive Hematological Malignancies, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 1 site in China.
Trial summary
The aim of this study is to evaluate the pharmacokinetic characteristics, safety and efficacy of the TQB2825 injection (subcutaneous administration) in patients with CD20-positive hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CD20-positive Hematological Malignancies
- What is being tested?
- TQB2825 Injection (Subcutaneous Injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Age 18 years or older and less than 80 years (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score 0 to 2 points;
- Expected survival greater than 12 weeks;
- Malignant hematological tumors diagnosed by histological or cytological means, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma, etc.;
- Immunophenotype analysis shows that the tumor is CD20 positive;
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- Previously received at least one adequate treatment with a CD20 monoclonal antibody regimen (combined chemotherapy or single drug), and the most recent adequate treatment did not lead to remission or disease progression after remission, or relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT);
- According to the 2014 Lugano criteria, there is at least one measurable lesion, that is, based on Computed Tomography (CT) cross-sectional images, the long diameter of lymph node lesions is greater than 15 mm or the long diameter of extranodal lesions is greater than 10 mm; Positron Emission Tomography - Computed Tomography scan (PET-CT) scan shows positive PET;
- Laboratory tests meet the following criteria (within 14 days before screening, no blood transfusion, no use of hematopoietic stimulating factors and other drugs to correct):
- Hemoglobin (HGB) ≥ 80 g/L;
- Absolute neutrophil count (NEUT) ≥ 1.0 × 109/L;
- Platelet count (PLT) ≥ 75 × 109/L (if accompanied by bone marrow invasion, platelet ≥ 50 × 109/L).
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If accompanied by liver metastasis, then ALT and AST ≤ 5 ULN;
- Serum creatinine (CR) ≤ 1.5 ULN or estimated glomerular filtration rate by Cockcroft-Gault formula ≥ 50 ml/min.
- Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5 × ULN (not receiving anticoagulant treatment);
- Pregnant women should agree to use effective contraceptive measures during the study period and within 12 months after the study ends. For men, they should agree to use effective contraceptive measures during the study period and within 12 months after the study ends.
Who cannot join
- Within the 5 years prior to the first medication administration, the subject had or currently has other malignant tumors. The following two situations can be included in the study: other malignant tumors treated by a single surgical procedure, achieving 5 consecutive years of disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (in situ cancer), and T1 (tumor infiltration of the basement membrane)];
- Previous treatment-induced adverse reactions have not recovered to a Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5.0) score of ≤1, except for grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, stable thyroid function hypofunction after hormone replacement therapy, etc., which are judged by the investigator to have no safety risks;
- Previous anti-tumor treatment:
- Within 4 weeks before the first administration, received chemotherapy, immunotherapy, monoclonal antibody treatment, radiation therapy within 2 weeks, or small molecule targeted drugs, or still within the 5 half-lives of the drug (based on the earliest occurrence time), calculate the washout period from the end of the last treatment;
- Treatment with Chinese patent medicines (including Compound Banmao Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Yadanzi Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.) that are explicitly approved by the National Medical Products Administration (NMPA) with anti-tumor indications in the package insert within 2 weeks prior to the first dose;
- Previously used other antibodies targeting both CD3 and CD20 for treatment;
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- Received Chimeric Antigen Receptor T-cell (CAR-T) treatment, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first administration;
- Lymphoma has previously or currently involved or is suspected to involve the central nervous system or lymphoma leukemia;
- Within 4 weeks before the first administration, received major surgical treatment, significant traumatic injury, or expected to undergo major surgery during the study treatment, or has long-standing unhealed wounds or fractures;
- Within 4 weeks before the first administration, experienced any bleeding or bleeding event ≥ Common Terminology Criteria for Adverse Events (CTC AE) 3 grade in the subject.
- Within 6 months before the first administration, had a thromboembolic event such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism, or any history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis is not considered "serious" thromboembolism);
- Has clinically significant uncontrolled need for repeated drainage of pleural effusion, ascites, or moderate or above pericardial effusion; Decompensated liver cirrhosis (Child-Pugh liver function rating of B or C) and active hepatitis (B).
- Pulmonary diseases, including any of the following conditions:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Master, 010-88196118, SongYQ_VIP@163.com
About this study
The aim of this study is to evaluate the pharmacokinetic characteristics, safety and efficacy of the TQB2825 injection (subcutaneous administration) in patients with CD20-positive hematological malignancies.
- Conditions
- CD20-positive Hematological Malignancies
- Being tested
- TQB2825 Injection (Subcutaneous Injection)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2825 Injection (Subcutaneous Injection)Drug
TQB2825 is a Cluster of Differentiation 3 × Cluster of Differentiation 20 (CD3×CD20) dual antibody, which can simultaneously target the CD20 on tumor cells and the CD3 on T cells. It can induce T cell activation, proliferation and cytokine release, and effectively target and kill tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| TQB2825 Injection (Subcutaneous Injection) | Experimental | The medication is administered once every two weeks, and the treatment lasts for 28 consecutive days, which constitutes one treatment cycle. Receives: Drug: TQB2825 Injection (Subcutaneous Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak time
Time to peak blood concentration after a single dose
Measured: Up to 4 month
Peak concentration Cmax
After a single dose, the highest point of the drug-time curve is called the peak concentration.
Measured: Up to 4 month
Plasma elimination half-life t1/2
The amount of time it takes for the concentration of the drug in the blood, or the amount of drug in the body, to drop to about half of its original level.
Measured: Up to 4 month
Secondary outcomes (8)
Incidence and severity of AE and Serious Adverse Event (SAE), and abnormal laboratory test indicators
Incidence and severity of AE and SAE, and abnormal laboratory test indicators
Measured: Up to 24 month
Overall response rate
To assess the percentage of patients with complete (CR) or partial response (PR) in the CD20-positive hematological tumor population who received the TQB2825 subcutaneous injection.
Measured: Up to 24 month
Complete response rate
To evaluate the percentage of complete response (CR) achieved by the subcutaneous injection of TQB2825 in patients with CD20-positive hematological malignancies.
Measured: Up to 24 month
Progression-free survival period
To evaluate the progression-free survival of TQB2825 subcutaneous injection in patients with CD20-positive hematological malignancies.
Measured: Up to 24 month
Duration of relief
To evaluate the duration of remission of the TQB2825 subcutaneous injection in patients with CD20-positive hematological malignancies.
Measured: Up to 4 month
Overall survival period
Evaluate the overall survival period of TQB2825 subcutaneous injection in patients with CD20-positive hematological malignancies.
Measured: Up to 4 month
Immunogenicity
Evaluation of the immunogenicity data of TQB2825 subcutaneous injection in patients with CD20-positive hematological malignancies.
Measured: Up to 8 month
Receptor occupancy rate
Evaluate the receptor occupancy rate of TQB2825 subcutaneous injection in patients with CD20-positive hematological malignancies.
Measured: Up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD20-positive Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110194
- Sponsor's protocol ID
- TQB2825-I-02
- Status last verified
- May 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of TQB2825 Subcutaneous Injection in CD20-positive Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07110194
- Acronym / sponsor ID
- TQB2825-I-02
- Conditions
- CD20-positive Hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Aug 2025 (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 aim of this study is to evaluate the pharmacokinetic characteristics, safety and efficacy of the TQB2825 injection (subcutaneous administration) in patients with CD20-positive hematological malignancies.
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 (Subcutaneous Injection) | Experimental | Drug: TQB2825 Injection (Subcutaneous Injection)The medication is administered once every two weeks, and the treatment lasts for 28 consecutive days, which constitutes one treatment cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Age 18 years or older and less than 80 years (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score 0 to 2 points;
- Expected survival greater than 12 weeks;
- Malignant hematological tumors diagnosed by histological or cytological means, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma, etc.;
Key exclusion criteria (13 listed)
- Within the 5 years prior to the first medication administration, the subject had or currently has other malignant tumors. The following two situations can be included in the study: other malignant tumors treated by a single surgical procedure, achieving 5 consecutive years of disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (in situ cancer), and T1 (tumor infiltration of the basement membrane)];
- Previous treatment-induced adverse reactions have not recovered to a Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5.0) score of ≤1, except for grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, stable thyroid function hypofunction after hormone replacement therapy, etc., which are judged by the investigator to have no safety risks;
- Previous anti-tumor treatment:
- Lymphoma has previously or currently involved or is suspected to involve the central nervous system or lymphoma leukemia;
- Within 4 weeks before the first administration, received major surgical treatment, significant traumatic injury, or expected to undergo major surgery during the study treatment, or has long-standing unhealed wounds or fractures;
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 Injection (Subcutaneous Injection)TQB2825 is a Cluster of Differentiation 3 × Cluster of Differentiation 20 (CD3×CD20) dual antibody, which can simultaneously target the CD20 on tumor cells and the CD3 on T cells. It can induce T cell activation, proliferation and cytokine release, and effectively target and kill tumor cells. | Drug | TQB2825 Injection (Subcutaneous Injection) |
Primary outcome
Peak time
Time frame: Up to 4 month
Time to peak blood concentration after a single dose
Peak concentration Cmax
Time frame: Up to 4 month
After a single dose, the highest point of the drug-time curve is called the peak concentration.
Plasma elimination half-life t1/2
Time frame: Up to 4 month
The amount of time it takes for the concentration of the drug in the blood, or the amount of drug in the body, to drop to about half of its original level.
8 secondary outcomes
Incidence and severity of AE and Serious Adverse Event (SAE), and abnormal laboratory test indicators
Time frame: Up to 24 month
Overall response rate
Time frame: Up to 24 month
Complete response rate
Time frame: Up to 24 month
Progression-free survival period
Time frame: Up to 24 month
Duration of relief
Time frame: Up to 4 month
Overall survival period
Time frame: Up to 4 month
Immunogenicity
Time frame: Up to 8 month
Receptor occupancy rate
Time frame: Up to 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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.
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 (Subcutaneous Injection) in people with CD20-positive Hematological Malignancies, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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 17 inclusion and 13 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: opening soon, as of the sponsor's last update on 7 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Peak time (time frame: Up to 4 month). 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 7 Aug 2025.