A Study of TQB3820 in Patients With Hematological Malignancies

Study Purpose

TQB3820 is a novel cereblon-modulating agent. Upon binding to cereblon, a substrate receptor in the cullin4 E3 ligase complex, TQB3820 promotes recruitment, ubiquitination, and subsequent proteasomal degradation of the hematopoietic transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). Modulation of Aiolos and Ikaros expression has the potential to correct multiple aspects of the immune dysregulation mediated by B cells.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. For Multiple Myeloma cohort. 1. Patients must have received at least 2 prior therapies; 2. Measurable levels of myeloma paraprotein. 1. M-protein in serum >5 g/L; 2. M-protein in urine >200mg/24h; 3. Light chain Multiple Myeloma without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 100 mg/L and abnormal serum immunoglobulin kappa lambda free light chain ratio. 2. For Indolent B-NHL. 1. Progressed after standard treatment or no standard treatment with an established survival benefit is available; 2. Imaging in screening showing at least one measurable lesion; In patients with CLL/SLL, circulating lymphocytes >= 5.0 × 10^9/L or lesions greater than 1.5 cm. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; 4. Life expectancy >=3 months; 5. Adequate organ/system function; 6. Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped;

Exclusion Criteria:

1. Patients received allogenic haemopoietic stem cell transplantation, or autologous stem cell transplantation within 3 months; 2. Diagnosed and/or treated additional malignancy within 3 years before the first dose; 3. With factors affecting oral medication; 4. Toxicity that is >=Grade 2 caused by previous cancer therapy; 5. Patients with congenital bleeding or coagulopathy, or are being treated with anticoagulants; 6. Patients with uncontrolled infections; 7. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 2 weeks before the first dose; 8. Has received Chinese patent medicines with anti-tumor indications that National Medical Products Administration(NMPA) approved within 2 weeks before the first dose; 9. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage; 10. Central nervous system metastases; 11. Has participated in other clinical studies within 4 weeks before the first dose; 12. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05020639
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hematological Malignancies
Arms & Interventions

Arms

Experimental: TQB3820 tablets

TQB3820 tablets are administrated orally on Days 1-28 of each 28-day treatment cycle. Dose escalation of TQB3820 will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data.

Interventions

Drug: - TQB3820 tablets

TQB3820 is a novel cereblon-modulating agent.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing, 100020

Site Contact

Wenming Chen, Doctor

13910107759@163.com

13910107759

Tianjin, Tianjin, China

Status

Recruiting

Address

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, Tianjin, 30020

Site Contact

Lugui Qiu, Doctor

qiulg@ihcams.ac.cn

022-23909172