Clinical Trial of TQB2825 in Subjects With CD20 Positive Hematological Tumors

NCT05489276 | Unknown Phase 1

• 1 other identifier: TQB2825- I-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hematological Tumors

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity（DLT）

  To evaluate DLT of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.

  104 weeks

• the maximum tolerated dose (MTD)

  To evaluate MTD of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.

  104 weeks

• Recommended Phase II Dose（RP2D)

  To evaluate RP2D of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.

  104 weeks

Secondary Outcomes (13)

• Adverse events (AE)

  Baseline up to 104 weeks

• serious adverse events (SAE)

  Baseline up to 104 weeks

• treatment-related adverse events(TRAE)

  Baseline up to 104 weeks

• Elimination half-life (to be used in one-or non- compartmental model) （t1/2)

  Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months

• Tmax

  Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months

Study Arms (1)

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.

Drug: TQB2825 injection

Interventions

TQB2825 injection DRUG

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.

TQB2825 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Immunophenotypic analysis showed CD20 positive.
• years old ≤ Age ≤75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
• 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.
• 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).
• 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.
• The subjects voluntarily joined the study and signed informed consent with good compliance.

You may not qualify if:

• 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.
• Previous anti-tumor therapy:
• Prior treatment with other antibodies targeting both CD3 and CD20;
• 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) .
• Associated diseases and medical history:
• Liver abnormalities: decompensated cirrhosis and active hepatitis;
• Renal abnormalities:

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yuqin Song, Master

CONTACT

010-88196118; SongYQ_VIP@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: August 5, 2022
• Study Start: March 22, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

CN (1)