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

April 6, 2026 updated by: Arovella Therapeutics Ltd

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
        • Contact:
          • Dr Salvatore Fiorenza
          • Phone Number: (03) 9903 0122
          • Email: acbd@monash.edu
      • Richmond, Victoria, Australia, 3121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Dose Level 1
50 × 10^6 CAR+ iNKT cells (starting dose level)
Drug: ALA-101
Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide
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
Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide
Experimental: Treatment Dose Level 2
150 × 10^6 CAR+ iNKT cells
Drug: ALA-101
Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide
Experimental: Treatment Dose Level 3
300 × 10^6 CAR+ iNKT cells
Drug: ALA-101
Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide
Experimental: Treatment Dose Level 4
500 × 10^6 CAR+ iNKT cells
Drug: ALA-101
Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the safety and tolerability of ALA-101 in adult participants with CD19+ NonHodgkin Lymphoma (NHL) and CD19+ leukemia
Time Frame: 2 years
Incidence, type and severity of treatment emergent and treatment-related adverse events (AEs) and Incidence and nature of dose-limiting toxicities (DLTs)
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 years
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.
2 years
To evaluate the preliminary efficacy of ALA-101 in adult participants with CD19+ NHL and/or CD19+ leukemia
Time Frame: 2 years
Overall Response Rate (ORR)
2 years
To characterize the PK profile of ALA-101
Time Frame: 1 year

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)
1 year
To evaluate the immunogenicity of ALA-101
Time Frame: 2 years
Incidence of anti-ALA-101 antibodies following ALA-101 administration.
2 years
To characterize the PK profile of ALA-101
Time Frame: 1 Year

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)
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arovella Therapeutics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALA-101-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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