Clinical Trials in Australia / NCT07518329
Starting soon
Phase 1
Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia.
NCT07518329 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Non Hodgkin Lymphoma (NHL)Leukaemia
Investigational drug(s) / intervention(s)
ALA-101
ALA-101: Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide
Study summary
Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101
Eligibility
Inclusion Criteria:
* Over 18 years old
* Confirmed Diagnoses of Confirmed diagnosis of CD19+ non-Hodgkins lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphatic Leukemia or Hairy Cell Leukemia
* Life Expectancy greater than 3 months
* Adequate Hepatic and Renal Function
* Adequate Bone Marrow Function
* Adequate ECG Vales
* Agree to use appropriate contraception to avoid becoming pregnant for up to 12 months post treatment and agree not to donate sperm or ova for 12 months post treatment
Exclusion Criteria:
* Prior anti-CD1d monoclonal antibody treatment
* Prior allogeneic stem cell transplant except where the participant is greater than 100 days and does not have Graft Versus Host Disease (uncontrolled)
* Prior Organ Transplant
* Previous Malignancy in last 3 years that's active or been treated.
* Current central nervous system involvement by lymphoma or leukaemia
* Evidence of Cardiac Dysfunction
* Active Autoimmune disease requiring systemic immunosuppressive therapy within the past 6 months.
* Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
* History of Graft Vs Host Disease Grade 2 to 4
* No active Graft Vs Host Disease following a minimum of 3 months withdrawal from all Graft Vs Host Disease treatments
* Must not have received systemic anti-cancer therapy for the underlying malignancy within 6 weeks prior to the start of conditioning chemotherapy on Day -6.
* Participants that have received autologous or allogenic CAR-T cell therapy within 3 months prior to commencing screening.
* Use of systemic corticosteroids within 15 days of commencement of conditioning chemotherapy on Day -6 or other immunosuppressive drugs within 30 days
* Recent major surgery (within 4 weeks prior to commencement of conditioning chemotherapy on Day -6) or planned major surgery within 8 weeks following ALA-101 infusion on Day 1.
* Active infection requiring intravenous antibiotic, antifungal, or antiviral medication or hospital admission within 10 days prior to commencement of conditioning chemotherapy on Day -6
* Severe (e.g., severe chronic obstructive pulmonary disease, severe Parkinson's disease) or poorly controlled (e.g., hypertension, diabetes, active inflammatory bowel disease) medical condition.
* Vaccinated with a live vaccine within 28 days prior to commencement of conditioning chemotherapy on Day -6 or planned live vaccination within 6 months following ALA-101 infusion.
Additional criteria apply.
Primary outcome measure(s)
- To evaluate the safety and tolerability of ALA-101 in adult participants with CD19+ NonHodgkin Lymphoma (NHL) and CD19+ leukemia — 2 years
Incidence, type and severity of treatment emergent and treatment-related adverse events (AEs) and Incidence and nature of dose-limiting toxicities (DLTs)
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| St. Vincent's Hospital | Sydney | New South Wales | |
| Mater Misericordiae Ltd (MML) | Brisbane | Queensland | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| The Alfred Hospital | Melbourne | Victoria | |
| Epworth HealthCare | Richmond | Victoria |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07518329 on ClinicalTrials.gov ↗ ← All trials in Australia