Ready-Made immune cells take on blood cancers in early trial
NCT ID NCT07518329
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This early-phase study tests a new cell therapy called ALA-101 for people with CD19+ non-Hodgkin lymphoma or leukemia. The therapy uses donor immune cells that are specially designed to find and attack cancer cells. The main goals are to check safety and find the best dose, with about 46 adults expected to join.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Epworth HealthCare
Richmond, Victoria, 3121, Australia
Contact Email: •••••@•••••
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Mater Misericordiae Ltd (MML)
Brisbane, Queensland, 4101, Australia
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Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
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St. Vincent's Hospital
Sydney, New South Wales, 2010, Australia
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The Alfred Hospital
Melbourne, Victoria, 3004, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas
- Can an antibody drug boost standard chemotherapy against an aggressive blood cancer?
- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?