Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia. (NCT07518329) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia.
Australia46 participantsStarted 2026-04-01
Plain-language summary
Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of ALA-101 in adult participants with CD19+ NonHodgkin Lymphoma (NHL) and CD19+ leukemia