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Trial Title:
Clinical Trial of TQB2825 in Subjects With CD20 Positive Hematological Tumors
NCT ID:
NCT05489276
Condition:
Hematological Tumors
Conditions: Official terms:
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2825 injection
Description:
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.
Arm group label:
TQB2825 injection
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 determine dose-limiting toxicity
(DLT), maximum tolerated dose (MTD) (if any), or optimal biological dose (OBD), and
recommended phase II dose (RP2D).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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:
1. 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)
2. Patients with refractory Anti-CD20 monoclonal antibody.
- 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.
Exclusion Criteria:
- 1 Tumor diseases and medical history:
1. Hematologic malignancies that have or are suspected to involve the central
nervous system (CNS) or primary CNS lymphoma;
2. 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)];
3. Clinically significant uncontrolled pleural effusion ascites requiring repeated
drainage and pericardial effusion with medium or higher volume.
- 2 Previous anti-tumor therapy:
1. Prior treatment with other antibodies targeting both CD3 and CD20;
2. Received any investigational antibody drug therapy, CAR T therapy, or other
immunocytotherapy, or auto-HSCT within 3 months prior to initial
administration;
3. Prior allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);
4. Any major surgery, chemotherapy and/or radiotherapy, immunotherapy or targeted
therapy within 4 weeks prior to initial administration;
5. 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);
6. Received proprietary Chinese medicines with anticancer indications specified in
NMPA approved drug instructions within 2 weeks prior to initial administration;
7. 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:
1. Liver abnormalities: decompensated cirrhosis and active hepatitis;
2. Renal abnormalities:
I. Renal failure requiring hemodialysis or peritoneal dialysis; II. Previous
history of nephrotic syndrome.
3. Gastrointestinal abnormalities:
I. Chronic diarrhea persists despite maximum medical treatment; II. Presence of
active inflammatory bowel disease within 4 weeks prior to initial
administration.
4. Cardiovascular and cerebrovascular abnormalities:
I. 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.
5. Medical history of immunodeficiency: known human immunodeficiency virus (HIV)
infection, or other acquired, congenital immunodeficiency disease;
6. Uncontrollable systemic bacterial, fungal or viral infection.
7. Lung disease:
I. 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.
8. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuqin Song, Master
Phone:
01088196118
Email:
SongYQ_VIP@163.com
Start date:
March 22, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05489276