CURE's Clinical Trial Corner: July 2020

As the cancer treatment landscape continues to grow, patients and their caregivers should be aware of the various clinical trials currently being conducted — and ones they can possibly join.

CD19-Positive Leukemias and Lymphomas

Ziopharm Oncology is currently enrolling patients with CD19-positive leukemias and lymphomas into a phase 1 clinical trial to evaluate its Rapid Personalized Manufacturing (RPM) CD19-specific CAR-T therapy.

Ziopharm expects to enroll up to 24 patients with advanced CD19-positive leukemias and lymphomas who have relapsed after receiving allogeneic bone marrow transplant. Measuring safety and maximum tolerated dose of the donor-derived genetically modified CD19-specific T cells manufactured using the RPM process is the main goal of the study.

“Our CAR-T therapy can be administered at low cell doses, which may control cytokine release syndrome and is appealing for the treatment of patients including those with CD19-expressing malignancies that have relapsed after allogeneic bone marrow transplantation,” said Ziopharm’s CEO Dr. Laurence Cooper in a press release. “There are limited effective treatment options for such patients as evidenced by the low rate of remission and poor long-term survival.”

The trial is now open for enrollment at The University of Texas MD Anderson Cancer Center.

Lung Cancer

Target Laboratories has enrolled the first patient in the phase 3 ELUCIDATE trial, which is evaluating the safety and efficacy of pafolacianine sodium in the surgical detection of lung cancer lesions.

“This pivotal study is pioneering the use of fluorescence guidance to intraoperatively identify lung cancer in real-time,” the study’s principal investigator Dr. Sunil Singhal, vice chair of translational research and the William Maul Measey Associate Professor in Surgical Research in the Perelman School of Medicine at the University of Pennsylvania, said in a press release. “Using a fluorescent imaging marker with high affinity and specificity for lung cancer allows surgeons to more effectively remove all the malignant tissue and have greater confidence in a complete resection.”

The aim of the multi-center trial, which is expected to comprise of up to 130 patients, is to assess the efficacy, safety and tolerability of pafolacianine sodium in patients with lung cancer.

Relapsed or Refractory Acute Myeloid Leukemia

Enrollment for the phase 3 ARMADA 2000 trial of CPI-613 (devimistat) for the treatment of relapsed or refractory acute myeloid leukemia has reached the midpoint to interim analysis.

Evaluating efficacy and safety of CPI-613 in combination with high-dose cytarabine and mitoxantrone in older patients is the main goal of the study.

“Actively and safely enrolling patients and reaching the midpoint to the first interim analysis is an achievement worth noting, especially given the challenges for clinical trial enrollment across the globe due to the coronavirus pandemic,” the study’s principal investigator Dr. Jorge Cortes, director of the Georgia Cancer Center at Augusta University, said in a press release. “Relapsed or refractory AML remains a significant challenge for older patients, so it is encouraging to see enrollment continue to grow.”

The Food and Drug Administration (FDA) ended up working closely with the drug’s manufacturer, Rafael Pharmaceuticals, to make changes to the protocol of the trial to help address challenges with patient enrollment.

Non-Small Cell Lung Cancer

The first patient has been dosed in a phase 2 trial assessing taletrectinib in patients with non-small cell lung cancer who have a ROS1 fusion.

“We have laid out an ambitious timeline for the taletrectinib global clinical development program for (tyrosine kinase inhibitor)-naive and -pretreated patients and have managed to remain on track with projections despite COVID-19 delays,” Dr. Bing Yan, the co-founder and chief medical officer of AnHeart, the manufacturer of taletrectinib. “We commend our investigators for this major milestone. We look forward to bringing taletrectinib to patients with ROS1 and NTRK mutations.”

There are additional plans to initiate another phase 2 trial across Japan, Korea, the United States and the European Union to assess taletrectinib in patients with locally advanced or metastatic solid tumors with NTRK fusions.

Get more news and updates on clinical trials here.