NeoImmuneTech has announced interim findings from its Phase Ib clinical trial of the combination of a CAR-T therapy with NT-I7 (efineptakin alfa) in treating large B-cell lymphoma (LBCL).
The trial, known as NIT-112, is evaluating the safety, tolerability, and recommended Phase II dose (RP2D), as well as NT-I7’s potential to enhance the expansion, persistence, and stemness of CAR-T cells in LBCL patients.
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This trial enrolled patients who had received established CAR-T therapies such as Kymriah, Yescarta, or Breyanzi, followed by an NT-I7 dose 21 days post-infusion.
The interim results highlighted that mid-level doses of NT-I7 (360, 480 µg/kg) maintained a stable safety profile.
No cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, which are typically high-risk side effects associated with CAR-T treatments.
The trial observed only mild side effects, such as injection site erythema and swelling, in six out of 11 participants.
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By GlobalDataThese side effects were said to be manageable and did not escalate beyond Grade 1-2 severity.
Furthermore, the addition of NT-I7 led to a significant increase in the amplification of CAR-T cells, extended their presence in the body, and enhanced T cell stemness.
The interim analysis also revealed an impressive overall response rate (ORR) of 81.1% among the patients, with seven achieving a complete response (CR) and two a partial response (PR).
This ORR is claimed to be notably higher than the 52% reported for Kymriah alone in LBCL patients.
NeoImmuneTech president and CEO Dr Luke Oh said: “We are thrilled by the preliminary results of study NIT-112 showing NT-I7’s ability to amplify CAR-T cells. This successful amplification of CAR-T cells is expected to translate into improved patient outcomes.
“NIT plans to actively pursue technology transfer related to the combination of NT-I7 with CAR-T therapies and we look forward to accelerating our discussions with the organisations already conducting preclinical studies combining NT-I7 with our own CAR-T technologies.”
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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