NCT05756322 The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
| NCT ID | NCT05756322 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Lin BioScience, Inc |
| Condition | Relapsed or Resistant Acute Leukaemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-07-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2023-07-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages. The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.
Eligibility Criteria
Inclusion Criteria: * Male or female subjects greater than 18 years old, inclusive. * Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL. * Patients who are ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. Exclusion Criteria: * Concomitant chemotherapy, radiation therapy, or immunotherapy. * Receiving any other investigational agents concurrently or within 30 days prior to screening. * Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement. * History of another active malignancy with 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively. * Patient with mental deficits and/or psychiatric history that precludes them from giving informed consent or from following protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05756322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Relapsed or Resistant Acute Leukaemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05756322 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05756322 currently recruiting?
Yes, NCT05756322 is actively recruiting participants. Contact the research team at clinicaltrial@linbioscience.com for enrollment information.
Where is the NCT05756322 trial being conducted?
This trial is being conducted at Tampa, United States, Chicago, United States, Fairway, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT05756322 clinical trial?
NCT05756322 is sponsored by Lin BioScience, Inc. The trial plans to enroll 90 participants.