TCR2 announces positive interim data from Phase 1 TC-210 trial
Category: #health  By Saipriya Iyer  Date: 2020-07-27
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TCR2 announces positive interim data from Phase 1 TC-210 trial

TCR2 Therapeutics Inc., a biotechnology company, has recently announced the positive interim data from the Phase 1 trial of its Phase 1/2 clinical study of TC-210. In the Phase 1 trial, the company had enrolled 5 patients diagnosed with mesothelin-expressing solid tumors.

All these 5 patients have indicated tumor regression in the trial. The trial also showed 2 RECIST unconfirmed partial responses and 2 patients with stable disease for 6 months. Furthermore, the translational data had demonstrated the expansion and activation of the TRuC-T cell. Out of these 5 patients, a controllable toxicity profile was observed in only 1 patient. This patient exhibited non-hematologic grade >2 toxicity related to TC-210, with no evidence of off-tumor/on-target toxicity or neurotoxicity.

Defining the TC-210’s safety profile in patients whose tumors overexpressed MSLN (mesothelin) as well as determining the RP2D (recommended Phase 2 dose) are the recent Phase 1 trial’s primary objectives. The secondary objectives include ORR (overall response rate) and DCR (disease control rate). Other exploratory objectives of the trial include the assessment of persistence, tumor infiltration, and expansion of TC-210 T cells.

In the trial, 40% of the patients met the MSLN expression cut-off as per the protocol. The TC-210 trial consists of 4 patients with mesothelioma and 1 with ovarian cancer. Additional key findings of the Phase 1 trial include:

  • 60% of the patients experienced CRS (Cytokine Release Syndrome), which was Grade 3 in 1 patient and Grade 1 in 2 patients.
  • All patients have had at least 1 disease response assessment.
  • Peak expansion of TC-210 has occurred between 7-22 days.

In the 2nd phase of the clinical study, nearly 50 patients are expected to obtain TC-210 at the recommended Phase 2 dose in 4 distinct cohorts. Each cohort will enroll 10 patients, except for the NSCLC cohort that will include 20 patients. Of these 20 patients, 8 patients will receive TC-210, while 12 patients will receive TC-210, combined with a PD-1 (programmed cell death 1) blocking antibody.

Source credit:

https://www.globenewswire.com/news-release/2020/07/26/2067629/0/en/TCR-Therapeutics-Announces-RECIST-Responses-with-First-TC-210-Dose-Tested-in-Advanced-Mesothelin-Expressing-Solid-Tumors.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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