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 range18 Years
SexALL
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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…
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