The CARMA study is a clinical Phase I/IIa trial evaluating the safety, optimal dosing, and preliminary efficacy of ELC-301 in patients with relapsed or refractory B-cell lymphoma that have undergone at least two previous lines of standard treatment with no remaining curative treatment options. The study includes a dose-escalation phase (Phase I) with twelve patients across three cohorts to identify the maximum tolerated dose, followed by further evaluation of six patients in an expansion phase (Phase IIa).

Key highlights from the data:

• 11 patients have so far undergone preliminary efficacy evaluation at the one-month follow-up.
• No dose-limiting toxicities (DLTs) have been observed, and the treatment has been well tolerated to date. The Data Safety and Monitoring Board (DSMB) has not yet assessed the third and final cohort of the Phase I part of the study.
• Among the 11 patients treated and evaluated for preliminary efficacy to date:
   
  • Disease control rate: 100%.
  • Overall response rate (ORR): 91% (10/11).
  • Complete metabolic response/CMR (no active disease): 55% (6/11).
  • Of the six patients with confirmed CMR at month one, four still had CMR at their most recent recorded follow-up.
  • One patient has confirmed CMR for at least 18 months. Another patient has confirmed CMR for at least 12 months.
• Three of the eleven evaluated patients had previously been treated with CAR T-cells but subsequently relapsed. After treatment with ELC-301, all three achieved disease control, of whom two obtained an objective tumor response, including one complete metabolic response.

• Of the three most recently included patients in the study, one had previously received CAR T treatment.

As soon as the twelfth and final patient in the Phase I part of the CARMA study has undergone their follow-up evaluation, the study's independent Data Safety and Monitoring Board (DSMB) will assess the third and final cohort. The DSMB's assessment will then determine the recommended Phase II dose (RP2D) to be used for continued enrollment in the dose-expansion part of the study (Phase IIa), where an additional six patients will be treated at the maximum tolerated dose.

"The eleven patients evaluated so far in the CARMA study continue to show strong data, with disease control in all patients and tumor responses in 91 percent. Three of them had previously received CAR T treatment and relapsed and are therefore defined as particularly difficult to treat. Among the three most recently included patients, one had stopped responding to their previous CAR T treatment - yet still achieved a tumor response with ELC-301. Particularly encouraging is that four of the six patients who achieved complete metabolic response remain disease-free, with one patient now disease-free for at least 18 months and another for at least 12 months. This is an early but important indication that the responses may be durable rather than temporary, which is critical for patients in this difficult-to-treat group and strengthens our confidence in the potential of ELC-301 and the iTANK platform. We now look forward to completing the evaluation of the final patient in the Phase I study, after which the DSMB will assess the last cohort ahead of the decision on continued enrollment in the dose-expansion part," says Jamal El-Mosleh, CEO of Elicera Therapeutics.