A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

Recruiting now · Phase 1/Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Large B-cell Lymphoma

In brief

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability, timing of administration and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in participants with B-cell malignancies post CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 and timing of administration will be evaluated in Phase I in order to define a recommended dosing level and time of administration for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.

Key facts

Study ID

NCT06045910

Run by

Cancer Research UK

People needed

84

Starts

2024-02-07

Expected to finish

2029-12-21

Last updated by the study team

2025-07-28

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For all participants
• Criteria to be met prior to enrolment in the trial:
• Aged 16 years or over.
• Written (signed and dated) informed consent and be capable of co-operating with ALETA-001 administration and follow-up.
• Confirmed diagnosis of B-cell NHL according to World Health Organization (WHO) 2016 criteria.
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
• Biochemical indices within protocol specified ranges.
• Cohort Specific Inclusion criteria (for Phase I Cohorts A \& B) Criteria to be met prior to enrolment in the trial.
• Histologically confirmed diagnosis of relapsed/refractory LBCL or MCL.
• Have received an approved anti-CD19 CAR T-cell therapy.
• Objectively evaluable or measurable disease at 4 weeks (±1 week) post CAR T, which demonstrates:
• inadequate or incomplete response (PR or SD), or
• PD if there is a reasonable expectation of deriving benefit from trial treatment, or
• initial response followed by relapse within 9 months assessed according to Lugano Criteria.
• Haematological indices within protocol specified ranges.
• Cohort Specific Inclusion criteria (for Phase I Cohorts C \& D) Criteria to be met prior to lymphodepleting chemotherapy for CAR T therapy.
• Histologically confirmed diagnosis of relapsed/refractory LBCL or MCL.
• Approved by the UK national CAR T Clinical Panel (NCCP) to receive an approved anti-CD19 CAR T-cell therapy.
• Haematological indices within protocol specified ranges.
• Adequate cardiac function within protocol specified ranges with no clinical symptoms or signs of heart failure.
• Resting O2 saturation of ≥92% on room air.
• Eligibility for participants in Phase II of the trial will depend on timing of administration of ALETA-001 which will be recommended by the Safety Review Committee (SRC).
• Exclusion Criteria for all participants:
• Active or previous malignancies of other types that, in the opinion of the Investigator, should exclude the participant. Exceptions include adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin and patients with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or who require only hormonal therapy and have had normal prostate specific antigen for >1 year prior to the start of therapy. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 2 years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
• Any ongoing toxic manifestation of previous anti-cancer treatment that, in the opinion of the Investigator, should exclude the participant.

Where it is running

• University Hospital Birmingham NHS Foundation Trust — Birmingham, United Kingdom (enrolling)
• Cambridge University Hospitals — Cambridge, United Kingdom (enrolling)
• St James's University Hospital — Leeds, United Kingdom (enrolling)
• University Hospital London Hospital — London, United Kingdom (enrolling)
• Manchester Royal Infirmary — Manchester, United Kingdom (enrolling)
• The Christie Hospital — Manchester, United Kingdom (enrolling)
• Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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