PTX-100 for Cutaneous T-Cell Lymphoma

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Prescient Therapeutics, Ltd.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles, then 21 day cycle thereafter. Subjects will be treated or followed up, if subjects discontinue treatment, for up to 18 months.

Eligibility Criteria

This trial is for individuals with Cutaneous T-Cell Lymphoma (CTCL) that has come back or didn't respond to previous treatments. Specific details about who can join are not provided, but typically participants need to meet certain health standards and may be required to have a particular stage of disease.

Inclusion Criteria

Life expectancy of 3 months or greater

A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment

My cancer is at least Stage Ib.

Exclusion Criteria

Has a known psychiatric disorder that would interfere with compliance with the requirements of the study

A history or current evidence of any condition, laboratory abnormality or other circumstance that might confound the results of the study or interfere with patient participation for the full duration of the study

Is a consumer of illicit or recreational drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence that in the judgment of the Investigator, would interfere with compliance with the requirements of the study

Treatment Details

Interventions

• PTX-100 (Monoclonal Antibodies)

Trial Overview The study tests PTX-100 at two different doses (500 or 1000 mg/m2) given through an IV over an hour on the first five days of a cycle. Initially, cycles are 14 days each for four cycles, then extend to 21-day cycles. Participants will be observed or continue treatment up to 18 months.

Participant Groups

Group I: Phase 2b PTX-100 Recommended Optimal Dose (ROD). Experimental Treatment 1 Intervention

Phase 2b PTX-100 will be the Recommended Optimal Dose form Phase 2a and follow the same infusion timeline outlined previously. IV infusion of RD over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles then followed by IV infusion of RD over 60 minutes on days 1 to 5 of a 21-day cycle up to 18months.

Group II: Phase 2a PTX-100 500mg/m2 Experimental Treatment 1 Intervention

Phase 2a PTX-100 will be 500mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months.

Group III: Phase 2a PTX-100 1000mg/m2 Experimental Treatment 1 Intervention

Phase 2a PTX-100 will be 1000mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months.

Who Is Running the Clinical Trial?

Prescient Therapeutics, Ltd.

Lead Sponsor

Trials

7

Recruited

260+