- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05020639
A Study of TQB3820 in Patients With Hematological Malignancies
September 18, 2021 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Phase I Study to Evaluate the Tolerability and Pharmacokinetics of TQB3820 in Relapsed or Refractory Multiple Myeloma (R/R MM) or Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (R/R B-NHL)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
116
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lugui Qiu, Doctor
- Phone Number: 022-23909172
- Email: qiulg@ihcams.ac.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Affiliated Beijing Chaoyang Hospital of Capital Medical University
-
Contact:
- Wenming Chen, Doctor
- Phone Number: 13910107759
- Email: 13910107759@163.com
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-
Tianjin
-
Tianjin, Tianjin, China, 30020
- Recruiting
- Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- Lugui Qiu, Doctor
- Phone Number: 022-23909172
- Email: qiulg@ihcams.ac.cn
-
Contact:
- Junyuan Qi, Doctor
- Phone Number: 022-23909067
- Email: qijy@ihcms.ac.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
For Multiple Myeloma cohort
- Patients must have received at least 2 prior therapies;
Measurable levels of myeloma paraprotein
- M-protein in serum >5 g/L;
- M-protein in urine >200mg/24h;
- 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.
For Indolent B-NHL
- Progressed after standard treatment or no standard treatment with an established survival benefit is available;
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- Life expectancy >=3 months;
- Adequate organ/system function;
- 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:
- Patients received allogenic haemopoietic stem cell transplantation, or autologous stem cell transplantation within 3 months;
- Diagnosed and/or treated additional malignancy within 3 years before the first dose;
- With factors affecting oral medication;
- Toxicity that is >=Grade 2 caused by previous cancer therapy;
- Patients with congenital bleeding or coagulopathy, or are being treated with anticoagulants;
- Patients with uncontrolled infections;
- Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 2 weeks before the first dose;
- Has received Chinese patent medicines with anti-tumor indications that National Medical Products Administration(NMPA) approved within 2 weeks before the first dose;
- Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage;
- Central nervous system metastases;
- Has participated in other clinical studies within 4 weeks before the first dose;
- According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
TQB3820 is a novel cereblon-modulating agent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity (DLT)
Time Frame: up to 18 months
|
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
|
up to 18 months
|
Maximum Tolerated Dose (MTD)
Time Frame: up to 18 months
|
The maximum Dose at which less than 33% subjects experiencing DLT
|
up to 18 months
|
Recommended Phase II Dose (RP2D)
Time Frame: up to 18 months
|
RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating pharmacokinetics (PK) data
|
up to 18 months
|
Adverse Events (AEs)
Time Frame: Baseline up to 24 months
|
Type, frequency, seriousness and severity of adverse events and laboratory abnormalities, such as hyperuricemia.
|
Baseline up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum (peak) plasma drug concentration (Cmax)
Time Frame: Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
|
Maximum plasma concentration of drug
|
Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
|
Time to reach maximum(peak )plasma concentration following drug administration (Tmax)
Time Frame: Hour 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
|
Time to Maximum plasma concentration of drug
|
Hour 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
|
Elimination half-life (t1/2)
Time Frame: Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0 (pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
|
Terminal-phase elimination half life
|
Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0 (pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
|
Overall response rate (ORR)
Time Frame: Baseline up to 24 months
|
The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate in MM The sum of percentage of participants with complete response rate, partial response rate for B-NHL
|
Baseline up to 24 months
|
Clinical benefit rate (CBR)
Time Frame: Baseline up to 24 months
|
The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate, minimal response rate in MM
|
Baseline up to 24 months
|
Time to response (TTR)
Time Frame: Baseline up to 24 months
|
Time from the first date of dose to the first date of documented response (partial response [PR] or greater).
|
Baseline up to 24 months
|
Duration of Response (DOR)
Time Frame: Baseline up to 24 months
|
Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD) or death from any cause, whichever occurs first
|
Baseline up to 24 months
|
Progression-free survival (PFS)
Time Frame: Baseline up to 24 months
|
Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
|
Baseline up to 24 months
|
Overall survival (OS)
Time Frame: Baseline up to 24 months
|
Time from the first dose to death due to any cause
|
Baseline up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2021
Primary Completion (Anticipated)
August 1, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 23, 2021
First Posted (Actual)
August 25, 2021
Study Record Updates
Last Update Posted (Actual)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 18, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB3820-I-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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