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Non Hodgkin Lymphoma (NHL)Phase 1SAPPHIRENCT07518329

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

A Phase 1 study testing ALA-101 in people with Non Hodgkin Lymphoma (NHL) and Leukaemia, run by Arovella Therapeutics Ltd at 5 sites in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma (NHL), Leukaemia
What is being tested?
ALA-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
5 sitesAustralia
Study dates
20 Aug 2026to 30 Aug 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Dr Danielle Blunt, 08 7074 0000, Health.CALHNClinicalTrials@sa.gov.au

  • Mater Misericordiae Ltd (MML)

    Brisbane, Queensland, 4101

    Stephan Boyle, Dr, 0731635200, Stephen.Boyle@mater.org.au

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Dr Salvatore Fiorenza, (03) 9903 0122, acbd@monash.edu

  • Epworth HealthCare

    Richmond, Victoria, 3121

    Dr Sumi Ratnasingam, 03 9426 0555, EHBloodCancer@epworth.org.au

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

    Wei Jiang, Dr, +61 2 93555657, Wei.jiang@svha.org.au

Other trials in Australia

About this study

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

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

Read the detailed description

This is a Phase 1, open-label, dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ALA-101, an allogeneic, off-the-shelf CD19-directed CAR-iNKT cell therapy, in patients with CD19-positive non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and hairy cell leukemia (HCL).

The dose-escalation phase will assess safety and determine the maximum tolerated dose (MTD). The dose-expansion/backfill phase will further evaluate safety and preliminary efficacy and establish the recommended Phase 2 dose (RP2D).

Study participation includes screening, lymphodepletion, treatment, and follow-up periods. An end-of-study visit will occur at Month 24, after which participants will enter a long-term follow-up study.

Being tested
ALA-101
Keywords
C19+, Lymphoma, Leukemia, CART T CELL, iNKT, CAR iNKT
Medical subject headings
Lymphoma, Non-Hodgkin, Leukemia, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALA-101Drug

    Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide

Study groups in NCT07518329
Study groupRoleWhat they receive
Treatment Dose Level 1Experimental50 × 10^6 CAR+ iNKT cells (starting dose level)
Receives: Drug: ALA-101
Treatment Dose Level -1ExperimentalDose level -1: 20 × 10^6 CAR+ iNKT cells (in case of DLTs on Dose Level 1)
Receives: Drug: ALA-101
Treatment Dose Level 2Experimental150 × 10^6 CAR+ iNKT cells
Receives: Drug: ALA-101
Treatment Dose Level 3Experimental300 × 10^6 CAR+ iNKT cells
Receives: Drug: ALA-101
Treatment Dose Level 4Experimental500 × 10^6 CAR+ iNKT cells
Receives: Drug: ALA-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety and tolerability of ALA-101 in adult participants with CD19+ NonHodgkin Lymphoma (NHL) and CD19+ leukemia

    Incidence, type and severity of treatment emergent and treatment-related adverse events (AEs) and Incidence and nature of dose-limiting toxicities (DLTs)

    Measured: 2 years

Secondary outcomes (5)

  1. To determine the maximum tolerated dose (MTD) and appropriate recommended Phase 2 dose (RP2D) for progression into next stages of clinical studies in adult participants with CD19+ NHL and/or CD19+ leukemia.

    Determination of MTD using isotonic regression and Determination of RP2D considering both the MTD and totality of safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) data collected.

    Measured: 2 years

  2. To evaluate the preliminary efficacy of ALA-101 in adult participants with CD19+ NHL and/or CD19+ leukemia

    Overall Response Rate (ORR)

    Measured: 2 years

  3. To characterize the PK profile of ALA-101

    Levels of ALA-101 in blood will be assessed using digital polymerase chain reaction (dPCR). Where data permits, endpoints to be evaluated include (but are not limited to):

    • Maximum observed Peak Plasma Concentration (Cmax)

    Measured: 1 year

  4. To evaluate the immunogenicity of ALA-101

    Incidence of anti-ALA-101 antibodies following ALA-101 administration.

    Measured: 2 years

  5. To characterize the PK profile of ALA-101

    Levels of ALA-101 in blood will be assessed using digital polymerase chain reaction (dPCR). Where data permits, endpoints to be evaluated include (but are not limited to):

    Area under the plasma concentration versus time curve (AUC)

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start20 Aug 2026 (estimated)
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion30 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518329
Sponsor's protocol ID
ALA-101-001
Acronym
SAPPHIRE
Status last verified
Aug 2026
First submitted
19 Feb 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALA-101 in people with Non Hodgkin Lymphoma (NHL) and Leukaemia, run by Arovella Therapeutics Ltd at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of ALA-101 in adult participants with CD19+ NonHodgkin Lymphoma (NHL) and CD19+ leukemia (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07518329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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