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

NCT05683717 | Recruiting Phase 1

• 1 other identifier: TT01488CN02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B-Cell Malignancies

Outcome Measures

Primary Outcomes (3)

• Dose-Limiting Toxicity (DLT) of TT-01488

  Safety and tolerability of TT-01488 as a single agent

  Up to 28 days after first dose

• Dose recommend for dose expansion (DRDE)

  Safety and tolerability of TT-01488 as a single agent

  3 years

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

  Safety and tolerability of TT-01488 as a single agent

  Up to 28 days after first dose

Secondary Outcomes (13)

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

  3 years

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

  3 years

• Maximum plasma concentration (Cmax)

  3 years

• Time to Maximum Plasma Concentration (Tmax)

  3 years

• Half-life (T1/2)

  3 years

Study Arms (2)

Dose Escalation for TT-01488

EXPERIMENTAL

TT-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.

Drug: TT-01488 Tablets

Dose Expansion for TT-01488

EXPERIMENTAL

TT-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.

Drug: TT-01488 Tablets

Interventions

TT-01488 Tablets DRUG

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

Dose Escalation for TT-01488; Dose Expansion for TT-01488

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• TransThera Sciences (Nanjing), Inc.: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Officials

• Li Jianyong

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Xu Wei

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Caixia, PhD

CONTACT

025-58216298; clinicaltrial@transtherabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: March 30, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 30, 2028
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)