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Hematological MalignanciesPhase 1NCT05020639

A Study of TQB3820 in Patients With Hematological Malignancies

A Phase 1 study testing TQB3820 tablets in people with Hematological Malignancies, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematological Malignancies
What is being tested?
TQB3820 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
2 sitesChina
Study dates
31 Aug 2021to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Lugui Qiu, Doctor contact

022-23909172

qiulg@ihcams.ac.cn

Junyuan Qi, Doctor contact

022-23909067

qijy@ihcams.ac.cn

China2 sites, 2 recruiting

  • Affiliated Beijing Chaoyang Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100020

    Wenming Chen, Doctor, 13910107759, 13910107759@163.com

    Recruiting

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

    Tianjin, Tianjin Municipality, 30020

    Lugui Qiu, Doctor, 022-23909172, qiulg@ihcams.ac.cn

    Junyuan Qi, Doctor, 022-23909067, qijy@ihcms.ac.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
TQB3820 tablets
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB3820 tabletsDrug

    TQB3820 is a novel cereblon-modulating agent.

Study groups in NCT05020639
Study groupRoleWhat they receive
TQB3820 tabletsExperimentalTQB3820 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.
Receives: Drug: TQB3820 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    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.

    Measured: up to 18 months

  2. Maximum Tolerated Dose (MTD)

    The maximum Dose at which less than 33% subjects experiencing DLT

    Measured: up to 18 months

  3. Recommended Phase II Dose (RP2D)

    RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating pharmacokinetics (PK) data

    Measured: up to 18 months

  4. Adverse Events (AEs)

    Type, frequency, seriousness and severity of adverse events and laboratory abnormalities, such as hyperuricemia.

    Measured: Baseline up to 24 months

Secondary outcomes (9)

  1. Maximum (peak) plasma drug concentration (Cmax)

    Maximum plasma concentration of drug

    Measured: 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)

  2. Time to reach maximum(peak )plasma concentration following drug administration (Tmax)

    Time to Maximum plasma concentration of drug

    Measured: 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)

  3. Elimination half-life (t1/2)

    Terminal-phase elimination half life

    Measured: 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)

  4. Overall response rate (ORR)

    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

    Measured: Baseline up to 24 months

  5. Clinical benefit rate (CBR)

    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

    Measured: Baseline up to 24 months

  6. Time to response (TTR)

    Time from the first date of dose to the first date of documented response (partial response [PR] or greater).

    Measured: Baseline up to 24 months

  7. Duration of Response (DOR)

    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

    Measured: Baseline up to 24 months

  8. Progression-free survival (PFS)

    Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first

    Measured: Baseline up to 24 months

  9. Overall survival (OS)

    Time from the first dose to death due to any cause

    Measured: Baseline up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start31 Aug 2021
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05020639
Sponsor's protocol ID
TQB3820-I-01
Status last verified
Sep 2021
First submitted
23 Aug 2021
Last updated
21 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB3820 tablets in people with Hematological Malignancies, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lugui Qiu, Doctor (022-23909172, qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: up to 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05020639.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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