LYT-200 for Acute Myeloid Leukemia and Preleukemia

Recruiting at 14 trial locations

Overseen By Aleksandra Filipovic, MD, PhD.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PureTech

Must not be taking: Immunosuppressants

Disqualifiers: Acute promyelocytic leukemia, Active tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: approximately 1 year

90 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk Myelodysplastic Syndrome (MDS)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research Team

Aleksandra Filipovic, MD, PhD.

Principal Investigator

PureTech Health

Eligibility Criteria

This trial is for adults over 18 with relapsed/refractory Acute Myeloid Leukemia or high-risk Myelodysplastic Syndrome, who've tried at least one treatment without success and have no other beneficial standard treatments available. Participants must be able to perform daily activities with relative ease (ECOG ≤ 2) and meet specific health criteria like a certain white blood cell count and organ function.

Inclusion Criteria

My AML has returned or didn't respond to treatment, and no standard treatments are suitable for me.

I can take care of myself and am up and about more than half of my waking hours.

I am willing and able to follow the study's requirements, including undergoing bone marrow biopsies.

Exclusion Criteria

Patient has any condition which, in the Investigator's opinion, makes the patient unsuitable for study participation

I have been diagnosed with acute promyelocytic leukemia.

I have cancer types other than AML or MDS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation study to identify the recommended Phase 2 dose (RP2D) of LYT-200, administered as a single agent or in combination with venetoclax and/or hypomethylating agents

28 days per cycle

Weekly visits for IV infusion

Treatment

Participants receive LYT-200 via IV infusion every week, with or without combination agents, to evaluate safety, tolerability, and preliminary efficacy

approximately 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LYT-200

Trial Overview LYT-200, a new potential therapy, is being tested in this Phase 1 trial for safety, how the body processes it (pharmacokinetics), and its effectiveness against AML/MDS. The study involves patients receiving LYT-200 to evaluate these aspects in those with advanced forms of these blood disorders.

Participant Groups

Group I: Single agent dose escalation Experimental Treatment 1 Intervention

LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week.

Group II: Combination agent dose escalation Experimental Treatment 4 Interventions

LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week, in combination with oral venetoclax Day 1, 100 mg, Day 2, 200mg, Day 3-28, 400 mg and/or azacitidine, 75 mg/m2 subcutaneously given for 7 days per cycle or decitabine 20 mg/m2 IV for 5 days per cycle.

Who Is Running the Clinical Trial?

PureTech

Lead Sponsor

Trials

7

Recruited

830+