{"id":149893,"date":"2024-10-08T14:12:01","date_gmt":"2024-10-08T14:12:01","guid":{"rendered":"https:\/\/news.talkwithrattan.com\/index.php\/2024\/10\/08\/aurigene-oncology-gets-dcgi-nod-for-phase-2-trials-of-car-t-cell-therapy-ribrecabtagene-autoleucel-times-of-india\/"},"modified":"2024-10-08T14:12:01","modified_gmt":"2024-10-08T14:12:01","slug":"aurigene-oncology-gets-dcgi-nod-for-phase-2-trials-of-car-t-cell-therapy-ribrecabtagene-autoleucel-times-of-india","status":"publish","type":"post","link":"https:\/\/news.talkwithrattan.com\/index.php\/2024\/10\/08\/aurigene-oncology-gets-dcgi-nod-for-phase-2-trials-of-car-t-cell-therapy-ribrecabtagene-autoleucel-times-of-india\/","title":{"rendered":"Aurigene Oncology gets DCGI nod for phase-2 trials of CAR-T cell therapy Ribrecabtagene autoleucel &#8211; Times of India"},"content":{"rendered":"<div style=\"text-align:center\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"225\" src=\"https:\/\/i0.wp.com\/static.toiimg.com\/thumb\/msid-114052194,imgsize-894563,width-400,resizemode-4\/114052194.jpg?fit=400,225&amp;ssl=1\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"Aurigene Oncology gets DCGI nod for phase-2 trials of CAR-T cell therapy Ribrecabtagene autoleucel &#8211; Times of India\" title=\"Aurigene Oncology gets DCGI nod for phase-2 trials of CAR-T cell therapy Ribrecabtagene autoleucel &#8211; Times of India\" \/><\/div><p> <br \/>\n<\/p>\n<div>\n<div class=\"MwN2O\">\n<div class=\"T22zO\">\n<section class=\"D3Wk1  clearfix id-r-component leadmedia undefined undefined  VtlfQ\" style=\"top:0px\">\n<div class=\"D3Wk1\" data-ua-type=\"1\" onclick=\"stpPgtnAndPrvntDefault(event)\">\n<div class=\"zPaFh\">\n<div class=\"wJnIp\"><\/div>\n<\/div>\n<\/div>\n<div class=\"cj2hz img_cptn\"><span title=\"Aurigene Oncology lab (Picture credit: Aurigene Oncology Limited)\">Aurigene Oncology lab (Picture credit: Aurigene Oncology Limited)<\/span><\/div>\n<\/section>\n<\/div><\/div>\n<p>HYDERABAD: <!-- -->Dr Reddy\u2019s Laboratories<!-- -->\u2019 wholly-owned subsidiary, <!-- -->Aurigene Oncology<!-- --> Limited, has received Drugs Controller General of India (DCGI) approval for conducting a phase-2 trial for India\u2019s first novel autologous <!-- -->BCMA<!-- --> (B-cell maturation antigen) directed CAR-T (chimeric antigen receptor) cell therapy called <!-- -->Ribrecabtagene autoleucel<!-- -->.<br \/>The DCGI nod comes after Aurigene Oncology, a clinical stage biotech, successfully conducted phase-1 trials for Ribrecabtagene autoleucel in patients suffering from relapsed or refractory <!-- -->multiple myeloma<!-- --> and is codenamed DRL-1801.<br \/>Ribrecabtagene autoleucel utilises a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. Dr Reddy\u2019s said DRL-1801 for the <!-- -->clinical trials<!-- --> is being manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology Limited in Bengaluru.<br \/>The phase-1 trial involved eight patients that were heavily pre-treated with a median of 5.5 previous lines of treatment. Most of these patients had also received transplant in the past and had disease progression post-transplant.<br \/>\u201cAll eight patients (100%) achieved clinical response, with five out of eight (62.5%) having achieved stringent complete response. With respect to safety, there were no high-grade events of <!-- -->Cytokine Release Syndrome<!-- --> (CRS) or neurotoxicity, in any of the patients,\u201d Dr Reddy\u2019s said in a regulatory filing with the bourses.<br \/>The results of the phase-1 study were also presented at the 21<sup>st<\/sup> annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently, the company said.<br \/>\u201cThe results from the trial in heavily pre-treated relapsed refractory <!-- -->myeloma patients<!-- --> are very exciting for us in India. We are thrilled with the data as the drug could be transformative for Indian patients with myeloma,\u201d Aurigene Oncology Ltd CEO Dr Murali Ramachandra said.<\/div>\n<p><script>\nvar _mfq = window._mfq || [];\n_mfq.push([\"setVariable\", \"toi_titan\", window.location.href]);\n!(function(f, b, e, v, n, t, s) {\n    function loadFBEvents(isFBCampaignActive) {\n      if (!isFBCampaignActive) {\n        return;\n      }\n      (function(f, b, e, v, n, t, s) {\n        if (f.fbq) return;\n        n = f.fbq = function() {\n          n.callMethod ? n.callMethod(...arguments) : n.queue.push(arguments);\n        };\n        if (!f._fbq) f._fbq = n;\n        n.push = n;\n        n.loaded = !0;\n        n.version = '2.0';\n        n.queue = [];\n        t = b.createElement(e);\n        t.async = !0;\n        t.defer = !0;\n        t.src = v;\n        s = b.getElementsByTagName(e)[0];\n        s.parentNode.insertBefore(t, s);\n      })(f, b, e, 'https:\/\/connect.facebook.net\/en_US\/fbevents.js', n, t, s);\n      fbq('init', '593671331875494');\n      fbq('track', 'PageView');\n    };\n    function loadGtagEvents(isGoogleCampaignActive) {\n      if (!isGoogleCampaignActive) {\n        return;\n      }\n      var id = document.getElementById('toi-plus-google-campaign');\n      if (id) {\n        return;\n      }\n      (function(f, b, e, v, n, t, s) {\n        t = b.createElement(e);\n        t.async = !0;\n        t.defer = !0;\n        t.src = v;\n        t.id = 'toi-plus-google-campaign';\n        s = b.getElementsByTagName(e)[0];\n        s.parentNode.insertBefore(t, s);\n      })(f, b, e, 'https:\/\/www.googletagmanager.com\/gtag\/js?id=AW-877820074', n, t, s);\n    };\n    function loadSurvicateJs(allowedSurvicateSections = []){\n      const section =  window.location.pathname.split('\/')[1]\n      const isHomePageAllowed = window.location.pathname === '\/' && allowedSurvicateSections.includes('homepage')\n      if(allowedSurvicateSections.includes(section) || isHomePageAllowed){\n        (function(w) {\n         function setAttributes() {\n                    var prime_user_status = window.isPrime ? 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