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

ConditionsNon Hodgkin Lymphoma (NHL)Leukaemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorArovella Therapeutics Ltd

About this trial

Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ALA-101

    Drug

    Single IV infusion of ALA-101 post chemotherapy conditioning with Fludarabine and Cyclophosphamide

Treatment groups

46 Participants
are divided into 5 treatment groups
Group A: Treatment Dose Level 1Experimental treatment 1 intervention
Group B: Treatment Dose Level -1Experimental treatment 1 intervention
Group C: Treatment Dose Level 2Experimental treatment 1 intervention
Group D: Treatment Dose Level 3Experimental treatment 1 intervention
Group E: Treatment Dose Level 4Experimental treatment 1 intervention

Trial outcomes

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)

Time frame
2 years

Secondary outcomes

1

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.

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.

Time frame
2 years
2

To evaluate the preliminary efficacy of ALA-101 in adult participants with CD19+ NHL and/or CD19+ leukemia

Overall Response Rate (ORR)

Time frame
2 years
3

To characterize the PK profile of ALA-101

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)

Time frame
1 year
4

To evaluate the immunogenicity of ALA-101

Incidence of anti-ALA-101 antibodies following ALA-101 administration.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arovella Therapeutics Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: