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Not yet recruitingNCT07518329SAPPHIREUpdated Aug 6, 2026

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

A Phase 1 interventional study of ALA-101 in Non Hodgkin Lymphoma (NHL) and Leukaemia, sponsored by Arovella Therapeutics Ltd. Not yet recruiting at 5 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Arovella Therapeutics Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Non Hodgkin Lymphoma (NHL)
  • Leukaemia

Keywords

  • C19+
  • Lymphoma
  • Leukemia
  • CART T CELL
  • iNKT
  • CAR iNKT
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's planned enrollment of 46 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

This is the only study on the registry with Arovella Therapeutics Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Treatment Dose Level 1

    50 × 10\^6 CAR+ iNKT cells (starting dose level)

    Drug: ALA-101

  • Experimental
    Treatment Dose Level -1

    Dose level -1: 20 × 10\^6 CAR+ iNKT cells (in case of DLTs on Dose Level 1)

    Drug: ALA-101

  • Experimental
    Treatment Dose Level 2

    150 × 10\^6 CAR+ iNKT cells

    Drug: ALA-101

  • Experimental
    Treatment Dose Level 3

    300 × 10\^6 CAR+ iNKT cells

    Drug: ALA-101

  • Experimental
    Treatment Dose Level 4

    500 × 10\^6 CAR+ iNKT cells

    Drug: ALA-101

Interventions

  • DrugALA-101

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

06

What researchers measure

Primary outcomes

  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)

    Time frame: 2 years

Secondary outcomes

  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.

    Time frame: 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)

    Time frame: 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): o Maximum observed Peak Plasma Concentration (Cmax)

    Time frame: 1 year

  4. To evaluate the immunogenicity of ALA-101

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

    Time frame: 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)

    Time frame: 1 Year

07

Study locations

5 sites
  • St. Vincent's Hospital
    Sydney, New South Wales 2010, Australia
  • Mater Misericordiae Ltd (MML)
    Brisbane, Queensland 4101, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Epworth HealthCare
    Richmond, Victoria 3121, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07518329
Lead sponsor
Arovella Therapeutics Ltd
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Mar 31, 2030 (estimated)
Completion
Aug 30, 2030 (estimated)
Last update
Aug 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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