New Clinical Trial: A Phase 1 Study to Investigate the Safety & Tolerability of REGN1979 in Patients with CD20+ B-Cell Malignancies Previously Treated with CD20-Directed Antibody Therapy

The Weill Cornell Lymphoma Program has recently opened a new research study for men and women with CD20+ B-cell malignancies, including B-NHL’s and CLL. The study is sponsored by Regeneron Pharmaceuticals, Inc. and the principal investigator is John Allan, MD. For more information about the study, please call Amelyn Rodriguez at 212-746-1362 or email her at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of CD20+ B-cell malignancy (B-NHL or CLL), with active disease not responsive to prior therapy.
  • Prior treatment with an anti-CD20 antibody therapy.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with CD20+ B-cell malignancies, including B-NHL and CLL.

The anti-CD20 monoclonal antibody (mAb), rituximab, has dramatically improved the prognosis for patients with NHL, and has been a mainstay of treatment since its first approval in 1997. While rituximab has single-agent activity in both indolent and aggressive NHL, and more modest activity in CLL, the standard of care is to use it in combination with chemotherapy. Response rates to conventional therapy are generally greater than 50%, but most patients will relapse. In the relapsed or salvage setting, there are no standard of care options and the choice of therapy is often guided by patient clinical factors, including performance status and the presence of comorbidities. Additionally, there is a growing body of data demonstrating the development of diminished activity of rituximab and rituximab resistance over time in multiple NHL subtypes.

REGN1979 is a bispecific (anti-CD20 and anti-CD3) monoclonal antibody, designed with a novel mechanism of action that is distinct from that of other anti-CD20 antibodies, and as such may provide a therapeutic benefit in patients who have relapsed following anti-CD20 mAb therapy. This first in human phase 1 study is designed to investigate the safety and tolerability of REGN1979.

Subjects will be assigned to a dose level cohort that will consist of an initial starting dose, followed by a higher dose for all subsequent administrations. REGN1979 will be administered as an IV infusion, weekly for the first four weeks, then monthly for five months, for a total of nine doses over six months. After completing the treatment period, subjects will have follow-up visits monthly for six months.

New Clinical Trial: A Phase 2 Study of the Efficacy & Safety of ACP-196 in Patients with Relapsed/Refractory CLL who are Intolerant to Ibrutinib Therapy

The Weill Cornell Lymphoma Program has recently opened a new research study for men and women with previously-treated chronic lymphocytic leukemia (CLL) who are intolerant to ibrutinib. The study is sponsored by the Acerta Pharma BV and the principal investigator is John Allan, MD. For more information about the study, please call Amelyn Rodriguez at 212-746-1362 or email her at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of CLL.
  • At least one prior therapy for CLL.
  • Intolerant to ibrutinib.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

Btk inhibition is an established therapeutic intervention for the treatment of CLL. In February 2014, ibrutinib (IMBRUVICA®) monotherapy, the first Btk inhibitor developed for clinical use, was approved in the United States for the treatment of patients with CLL who have had ≥ 1 prior therapy or 17p deletion based on high response rates with few drug-related toxicities. However, ibrutinib is not without its adverse reactions. This study will evaluate the safety and efficacy of the second-generation Btk inhibitor, ACP-196, in subjects who have previously discontinued ibrutinib therapy due to adverse reactions. Preliminary data to date suggests that ACP-196 is very well tolerated and has robust activity as a single agent in the treatment of subjects with relapsed/refractory CLL. Additionally, PK/PD results show the 100-mg BID regimen produces optimal target coverage over 24 hours, which may provide greater clinical benefit than the QD regimen of ibrutinib. This study will explore whether ACP-196, as an alternative Btk inhibitor, with a potentially distinct safety profile, may fill an unmet need in therapeutic options for patients who are intolerant to ibrutinib.

Subjects will receive ACP-196 orally twice daily continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Subjects who are continuing to tolerate and derive clinical benefit from treatment at the end of the trial may continue to receive their study treatment after discussion with the medical monitor. After discontinuing treatment, subjects will remain in long-term follow-up until loss to follow-up, consent withdrawal, or study closure.

REDLAMP 9: Prognostic Factors for Clinical Outcomes in Patients with Plasmablastic Lymphoma

Plasmablastic lymphoma is an aggressive diffuse large B-cell lymphoma commonly associated with HIV infection, and an unfavorable diagnosis. Though it’s also often found in immunocompetent patients. The Journal of Hematology & Oncology recently published a clinicopathologic analysis of patients with plasmablastic lymphoma, and measured their outcomes. In this video, Dr. John Allan explains the results of this study, and offers takeaways for patients with this aggressive lymphoma.

Previous #REDLAMP entries can be viewed on our Youtube channel.

We encourage you to follow the Lymphoma Program on Twitter, Youtube, and Facebook where we will highlight new videos are about research publications as they are released. We also welcome your feedback, suggestions and questions about this project. If you have other questions about our lymphoma program or clinical trials or would like to see one of our lymphoma specialists, please contact us at 212-746-2919.