Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia.
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
1 other identifier
interventional
46
1 country
3
Brief Summary
Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2026
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2030
April 8, 2026
April 1, 2026
4 years
February 19, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
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)
2 years
Secondary Outcomes (5)
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.
2 years
To evaluate the preliminary efficacy of ALA-101 in adult participants with CD19+ NHL and/or CD19+ leukemia
2 years
To characterize the PK profile of ALA-101
1 year
To evaluate the immunogenicity of ALA-101
2 years
To characterize the PK profile of ALA-101
1 Year
Study Arms (5)
Treatment Dose Level 1
EXPERIMENTAL50 × 10\^6 CAR+ iNKT cells (starting dose level)
Treatment Dose Level -1
EXPERIMENTALDose level -1: 20 × 10\^6 CAR+ iNKT cells (in case of DLTs on Dose Level 1)
Treatment Dose Level 2
EXPERIMENTAL150 × 10\^6 CAR+ iNKT cells
Treatment Dose Level 3
EXPERIMENTAL300 × 10\^6 CAR+ iNKT cells
Treatment Dose Level 4
EXPERIMENTAL500 × 10\^6 CAR+ iNKT cells
Interventions
Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide
Eligibility Criteria
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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Epworth HealthCare
Richmond, Victoria, 3121, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2026
First Posted
April 8, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
March 31, 2030
Study Completion (Estimated)
August 30, 2030
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share