ALA-101 in CD19+ blood cancers
Official title: A Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101, Allogeneic, Off-the-shelf, CD19-directed CAR-iNKT Cells in Patients With CD19+ Non-Hodgkin Lymphoma and Leukemia
Run by Arovella Therapeutics Ltd · NCT07518329 · Data updated 2026-11-12
A small early-phase test to see if ALA-101, an off-the-shelf CAR-iNKT cell therapy, is safe and potentially effective in adults with CD19-positive NHL or leukemia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Arovella Therapeutics Ltd Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 5 sites (Sydney, New South Wales and 4 other locations) |
| Status | Recruiting |
| Started | October 19, 2026 |
| Main results expected | March 31, 2030 |
| Study ends | August 30, 2030 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07518329 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with confirmed CD19-positive NHL or related leukemias who meet organ function and health criteria and are able to comply with contraception and follow-up requirements.
✕Probably not a fit
Patients with active CNS involvement, certain pre-existing cardiac or autoimmune conditions, recent malignancies, or those who do not meet organ-function criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 open-label, dose-escalation and expansion study assessing ALA-101, an allogeneic CD19-directed CAR-iNKT cell therapy, in adults with CD19-positive NHL and certain leukemias. The trial's primary goals are safety and tolerability, with secondary aims to characterize pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy. The study starts with escalating doses to identify the maximum tolerated dose, followed by expansion to establish a recommended Phase 2 dose. Participants will undergo screening, lymphodepletion, treatment, and a 24-month end-of-study visit, with long-term follow-up thereafter. Locations include sites in Sydney, Brisbane, and Adelaide, Australia, led by Arovella Therapeutics Ltd.
Why it matters
Potential benefit: If successful, participants could experience tumor control signals and lay the groundwork for a potentially new off-the-shelf CAR-iNKT therapy for CD19-positive cancers.
How similar studies have gone: Early CAR-iNKT and allogeneic CAR-T approaches have shown safety signals and hints of efficacy in hematologic malignancies, but this exact CAR-iNKT CD19 therapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The Alfred Hospital
Melbourne, Victoria, Australia Recruiting -
St. Vincent's Hospital
Sydney, New South Wales, Australia Not yet recruiting -
Mater Misericordiae Ltd (MML)
Brisbane, Queensland, Australia Not yet recruiting -
Royal Adelaide Hospital
Adelaide, South Australia, Australia Not yet recruiting -
Epworth HealthCare
Richmond, Victoria, Australia Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.