Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia.

Starting soon · Phase 1

Conditions studied: Non Hodgkin Lymphoma (NHL), Leukaemia

In brief

Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101

Key facts

Study ID

NCT07518329

Run by

Arovella Therapeutics Ltd

People needed

46

Starts

2026-08-20

Expected to finish

2030-08-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• St. Vincent's Hospital — Sydney, New South Wales, Australia
• Mater Misericordiae Ltd (MML) — Brisbane, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Epworth HealthCare — Richmond, Victoria, Australia

Full record on ClinicalTrials.gov

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