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B-Cell MalignanciesPhase 1NCT05683717

A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies

A Phase 1 study testing TT-01488 Tablets in people with B-Cell Malignancies, run by TransThera Sciences (Nanjing), Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Malignancies
What is being tested?
TT-01488 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
30 Mar 2023to 30 Oct 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Participants with histologically confirmed B-cell malignancy, failed or intolerant to either ≥ 2 prior standard/common regimens given in combination or sequentially OR have received 1 prior BTK-containing regimen, relapse/refractory, and with treatment indication:
  • CLL/SLL treated with prior immunochemistry or BTK inhibitor containing regimen;
  • DLBCL treated with prior CD20 or anthracyclines containing regimen;
  • Other types of B-cell NHL treated with prior CD20 containing regimen
  • Adequate organ function, defined by the following laboratory parameters:
  • Hematologic:
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  • Absolute neutrophil count (ANC) ≥ 0.75×10^9/L, and ≥ 0.5×10^9/L if bone marrow involved
  • Platelets ≥ 50×10^9/L without transfusion within 7 days, and ≥ 30×10^9/L if bone marrow involved
  • Hemoglobin ≥ 8.0 g/dL without transfusion within 7 days, and ≥ 7.0 g/dL if bone marrow involved
  • Coagulation:
  • Prothrombin time (PT) ≤ 1.5 × ULN
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
  • Renal function:
  • Creatinine clearance ≥ 30 mL/min estimated glomerular filtration rate based on Cockcroft-Gault formula
  • Liver function:
  • Total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's disease)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN unless disease-related

Who cannot join

  • Women who are pregnant or lactating
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years or which will not limit survival to < 2 years (Note: these cases must be discussed with the Medical Monitor and/or Investigator)
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or significant screening ECG abnormalities
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days or with any of the following:
  • Active graft versus host disease (GvHD);
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  • Cytopenias from incomplete blood cell count recovery post-transplant;
  • Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > Grade 1 from CAR-T therapy;
  • Ongoing immunosuppressive therapy
  • Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy, including radiation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sun Caixia, PhD contact

025-58216298

clinicaltrial@transtherabio.com

China1 site, 1 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Jianyong Li, M.D., lijianyonglm@126.com

    Wei Xu, M.D., xuwei10000@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Multicenter, Open Label, and Dose-Escalation Study of TT-01488, Administered Orally in Adult Patients With B-Cell Malignancies

This is a multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.

Read the detailed description

The study will consist of two parts, dose escalation and dose expansion. A modified 3+3 design will be used to guide the dose escalation and the determination of the dose recommended for dose expansion (DRDE). A sentinel cohort comprising of one subject will be enrolled at a starting dose of 50 mg q.d. Subsequently, patients will be enrolled according to the standard 3+3 dose escalation design to determine the DRDE. Once the DRDE has been selected, TT-01488 of DRDE will be further tested in the dose expansion cohort to verify the safety and preliminary efficacy as observed in the dose escalation cohorts. A recommended Phase II dose (RP2D) may be determined based on the totality of safety, pharmacokinetics, and efficacy data from the dose escalation cohorts and dose expansion cohort.

Being tested
TT-01488 Tablets

What participants receive

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

  • TT-01488 TabletsDrug

    TT-01488 tablet will be administered orally once daily per protocol defined schedule.

Study groups in NCT05683717
Study groupRoleWhat they receive
Dose Escalation for TT-01488ExperimentalTT-01488 tablets will be administered once daily in a 28-day cycle in increasing strength in order to determine the recommended dose for dose expansion.
Receives: Drug: TT-01488 Tablets
Dose Expansion for TT-01488ExperimentalTT-01488 tablets will be administered once daily in 28-day cycles to verify the safety and preliminary efficacy as observed in the dose escalation cohorts.
Receives: Drug: TT-01488 Tablets

What is being measured

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

  1. Dose-Limiting Toxicity (DLT) of TT-01488

    Safety and tolerability of TT-01488 as a single agent

    Measured: Up to 28 days after first dose

  2. Dose recommend for dose expansion (DRDE)

    Safety and tolerability of TT-01488 as a single agent

    Measured: 3 years

  3. Maximum Tolerated Dose (MTD), if reached, of TT-01488

    Safety and tolerability of TT-01488 as a single agent

    Measured: Up to 28 days after first dose

Secondary outcomes (13)

  1. Number of participants with treatment-related adverse events (AEs)

    Safety and tolerability of TT-01488 as a single agent. AEs will be assessed per CTCAE v5.0 or 2018 IWCLL and may include, but is not limited to, clinically abnormal laboratory tests, physical exams, vital signs, electrocardiograms, and ECOG performance status.

    Measured: 3 years

  2. Area under the concentration time curve (AUC 0-t)

    Pharmacokinetic (PK) profile of TT-01488 as a single agent

    Measured: 3 years

  3. Maximum plasma concentration (Cmax)

    Pharmacokinetic (PK) profile of TT-01488 as a single agent

    Measured: 3 years

  4. Time to Maximum Plasma Concentration (Tmax)

    Pharmacokinetic (PK) profile of TT-01488 as a single agent

    Measured: 3 years

  5. Half-life (T1/2)

    Pharmacokinetic (PK) profile of TT-01488 as a single agent

    Measured: 3 years

  6. Mean Residence Time (MRT)

    Pharmacokinetic (PK) profile of TT-01488 as a single agent

    Measured: 3 years

  7. Apparent volume of distribution associated with the terminal phase (Vz/F)

    Pharmacokinetic (PK) profile of TT-01488 as a single agent

    Measured: 3 years

  8. Apparent clearance (CL/F)

    Pharmacokinetic (PK) profile of TT-01488 as a single agent

    Measured: 3 years

  9. Objective Response Rate (ORR)

    Preliminary efficacy profile of TT-01488 as a single agent

    Measured: 3 years

  10. Disease Control Rate (DCR)

    Preliminary efficacy profile of TT-01488 as a single agent

    Measured: 3 years

  11. Duration of Response (DOR)

    Preliminary efficacy profile of TT-01488 as a single agent

    Measured: 3 years

  12. Progression free survival (PFS)

    Preliminary efficacy profile of TT-01488 as a single agent

    Measured: 3 years

  13. Overall survival (OS)

    Preliminary efficacy profile of TT-01488 as a single agent

    Measured: 3 years

Timeline

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

  1. First posted13 Jan 2023
  2. Study start30 Mar 2023
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion30 Oct 2028 (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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05683717
Sponsor's protocol ID
TT01488CN02
Status last verified
Nov 2023
First submitted
4 Jan 2023
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TT-01488 Tablets in people with B-Cell Malignancies, run by TransThera Sciences (Nanjing), Inc. at 1 site 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 17 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Sun Caixia, PhD (025-58216298, clinicaltrial@transtherabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) of TT-01488 (time frame: Up to 28 days after first dose). The study lists 3 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 NCT05683717.

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 Nov 2023.

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