Aleta Biotherapeutics is working to initiate a potentially registrational trial in the US for its CAR T-cell therapy engager (CTE) ALETA-001, CEO Dr Paul Rennert told Clinical Trials Arena.

The US-based immune-oncology company plans to file an investigational new drug (IND) application to the US Food and Drug Administration (FDA) at the end of H2 2024 but aims to set up a pre-IND meeting by the end of this year.

Aleta hopes that the upcoming trial will be a registrational study with an estimated initiation date in Q4 2024 or early 2025, Rennert said. The company plans to enrol 125 patients with B-cell malignancies who are unresponsive after receiving an anti-CD-19 CAR T-cell therapy.

Rennert explained that 35% of the patients who are in a complete response subsequently relapse and have poor outcomes. The median progression-free survival (PFS) post-relapse is under five months. He said: “If we could come back with a meaningful increase in ongoing response at six months and 12 months and a PFS benefit at six months and 12 months, that would be sufficient.”

ALETA-001 is a CAR T-cell therapy engager that contains CD19 target protein. Aleta’s lead candidate is designed to improve the effectiveness of CD19-directed CAR T-cell therapies.

Upcoming Phase I/II trial in the UK

Last month, Aleta was granted clinical trial authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its Phase I/II trial (NCT06045910). Rennert said that the company is still on track to enrol patients this year, most likely within the next month.

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Aleta is currently scheduling site initiation visits across six centres in the UK. Aleta is collaborating with Cancer Research UK, which is sponsoring the trial and is responsible for the clinical and regulatory operations.

The Phase I portion of the trial will recruit 12–18 patients who are not in complete response after receiving an anti-CD 19 CAR T-cell therapy 28 days earlier. Participants will then receive ALETA-001 to boost the therapy’s activity.

However, the company is working on a protocol amendment that would allow an earlier administration of ALETA-001 on day 14. This modification would add six more patients to Phase I. The amendment will be filed when Aleta has initial safety data from the first 12 patients.

In the Phase II part, Aleta will recruit 20 patients across three cohorts. The first cohort will recruit patients with large B-cell lymphomas who received Kite Pharma’s Yescarta (axicabtagene ciloleucel) or NovartisKymriah (tisagenlecleucel). The second cohort will focus on patients with mantle cell lymphoma (MCL) who received Kite’s Tecartus (brexucabtagene autoleucel).

The third cohort will enrol both lymphoma and MCL patients, but they will receive ALETA-001 on day 14 rather than day 28.

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