New Site Added to Phase I Trial of Lymphir for the Treatment of B-Cell Lymphoma
NCI-designated research and treatment center, City of Hope, in Duarte, CA will participate in UMN’s ongoing Phase I study.
The University of Minnesota (UMN) Masonic Cancer Center is expected to expand its ongoing investigator-initiated Phase I clinical trial (NCT0485525) of Lymphir (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas (BCL). The site location being added to the ongoing study is National Cancer Institute (NCI)-designated research and treatment center, City of Hope, located in Duarte CA. It is one of only 53 NCI-designated cancer centers in the United States.1
Citius Pharmaceuticals is collaborating with UMN in this investigator-initiated study. The Phase I dose-finding clinical trial to evaluate Lymphir prior to CAR-T therapies Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel), or Breyanzi (lisocabtagene maraleucel) in patients with BCL was initiated in May 2021. Enrollment is underway for patients diagnosed with relapsed or refractory BCL, for which treatment with CAR-Ts is planned, and who are considered at high risk for progression after CAR-T therapy.
"We are encouraged by the scientific community's interest in exploring the potential benefits of LYMPHIR beyond cutaneous T-cell lymphoma, for which a Biologics License Application is currently under review by the FDA. We are very excited to support UMN's expansion of its study to City of Hope as distinguished oncologists Veronika Bachanova, MD, PhD and Matthew Mei, MD conduct innovative research to evaluate LYMPHIR in combination with CAR-T treatment," Myron Czuczman, MD, chief medical officer of Citius said in a press release. "This first-of-its-kind study will evaluate the potential value that transient depletion of T-regs within the tumor microenvironment by LYMPHIR has upon CAR-T-based anti-tumor activity.”
"This trial is designed to augment lymphodepletion prior to CAR-T cells by administration of targeted immunotoxin against IL-2 receptor-positive regulatory T-cells. The lymphodepleting chemotherapy augmented with LYMPHIR was combined with all three standard of care CAR-T products for diffuse large B-cell lymphomas in second or third line of therapy. We look forward to welcoming patients from City of Hope as we expand the trial and evaluate the maximum tolerated dose," principal investigator Bachanova, MD, PhD, division of hematology, oncology, and transplantation, department of medicine, University of Minnesota said in the press release.
Earlier in March 2024, Citius resubmitted a biologics license application (BLA) to the FDA for Lymphir to treat patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL) after previous administration of at least one systemic therapy.2
The resubmission of the BLA was based on findings from a Phase III study (NCT01871727). The trial’s primary endpoint was objective response rate (ORR), with secondary endpoints that included duration of response, time to response, skin response, duration of skin response, safety, and tolerability. Exploratory endpoints included progression-free survival, time to progression, pruritus improvement, and quality of life.
"The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL. No concerns relating to safety or efficacy were noted in the letter, and we remain confident in the robustness of the clinical data package included with the initial BLA submission," Leonard Mazur, chairman and CEO of Citius said in an earlier press release.
References
1. Citius Pharmaceuticals Announces Addition Of City Of Hope To UMN's Phase 1 Trial Of LYMPHIR In Combination With CAR-T For The Treatment Of B-Cell Lymphoma. News release. April 11, 2024. Accessed April 15, 2024. https://citiuspharma.com/investors/news-media/news/release-details/2024/Citius-Pharmaceuticals-Announces-Addition-of-City-of-Hope-to-UMNs-Phase-1-Trial-of-LYMPHIR-in-Combination-with-CAR-T-for-the-Treatment-of-B-Cell-Lymphoma/default.aspx
2. Citius Pharmaceuticals Announces FDA Acceptance Of The BLA Resubmission Of LYMPHIR™ (Denileukin Diftitox) For The Treatment Of Adults With Relapsed Or Refractory Cutaneous T-Cell Lymphoma. News release. March 18, 2024. Accessed April 15, 2024. https://citiuspharma.com/investors/news-media/news/release-details/2024/Citius-Pharmaceuticals-Announces-FDA-Acceptance-of-the-BLA-Resubmission-of-LYMPHIR-Denileukin-Diftitox-for-the-Treatment-of-Adults-with-Relapsed-or-Refractory-Cutaneous-T-Cell-Lymphoma/default.aspx
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