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A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies

A Phase I Clinical Trial Evaluating the Safety and Efficacy of TQB2101 in Subjects With Advanced Hematologic Malignancies

NCT07113925•Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

TQB2101 for Injection is an Antibody-Drug Conjugate (ADC) targeting Receptor Tyrosine Kinase Like Orphan Receptor 1 (ROR1).It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.
•Age between 18 and 75 years (calculated based on the date of signing the informed consent form).
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
•Expected survival \>12 weeks.
•Subjects with advanced hematologic malignancies confirmed by cytology/histopathology, who have failed standard treatment or lack effective treatment options.
•At least one measurable lesion according to the 2014 Lugano criteria: lymph node lesions with long axis \>15mm or extranodal lesions with long axis \>10mm on CT cross-sectional imaging.
•Adequate organ function meeting the following criteria:
•1. Hemoglobin (HGB) ≥80g/L
•2. Absolute neutrophil count (ANC) ≥1.0×10⁹/L
•3. Platelet count (PLT) ≥75×10⁹/L (≥50×10⁹/L if with bone marrow involvement)
+5 more criteria

Exclusion Criteria

•Patients with other malignant tumors that occurred within 3 years before the first administration or currently coexisting with other malignant tumors are excluded, except for those who have undergone a single surgical treatment for other malignant tumors and have achieved a disease-free survival (DFS) of 5 consecutive years; patients with cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\] are eligible for inclusion.
•Tumor-related symptoms and treatments:
•1. Lymphoma involving or suspected to involve the central nervous system, or primary central nervous system lymphoma;
•2. Patients who have received chemotherapy, immunotherapy within 4 weeks before the first administration, radiotherapy or small molecule targeted drugs within 2 weeks, or are still within 5 half-lives of the drug (whichever occurs earlier), with a washout period calculated from the end of the last treatment;
•3. Patients who have received treatment with traditional Chinese medicine with clear anti-tumor indications in the National Medical Products Administration (NMPA) approved drug instructions (including Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea javanica Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.) within 2 weeks before the first administration;
•4. Patients who have previously received treatment with ROR1 inhibitor drugs;
•5. Patients who have participated in other anti-tumor drug clinical trials within 4 weeks before the first administration (calculated from the last use of the trial drug) and have used the trial drug, or are still within 5 half-lives of the study drug (whichever is shorter).
•Patients with adverse reactions from previous treatments that have not recovered to a Common Terminology Criteria for Adverse Events Version 5.0 (CTC AE v5.0) grade score of ≤1, except for alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which are judged by the investigator to have no safety risks.
•Patients who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period (except for surgeries specified in the protocol) within 4 weeks before the first administration, or have long-term unhealed wounds or fractures.
•Patients who have experienced any bleeding event ≥ CTC AE v5.0 grade 3 within 4 weeks before the first administration, or have bleeding or coagulation disorders and are using warfarin, aspirin, or other antiplatelet aggregation drugs (except for maintenance doses: aspirin ≤ 100mg/d, clopidogrel ≤ 75mg/d), or have any bleeding signs or history judged by the investigator to be unsuitable for inclusion.
+23 more criteria

Locations (3)

The Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 1, 2025

Primary Completion Date

December 1, 2025

Completion Date

June 1, 2028

Last Updated

August 11, 2025

Enrollment

114

ESTIMATED participants

Conditions

Advanced Hematologic Malignancies

Interventions

TQB2101 for Injection

DRUG

Contacts

Peng Liu, Doctor

CONTACT

18222106302 liupeng@zs-hospital.sh.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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