The Gabrail Cancer and Research Center, a PhaseWell Research site, today announced that Nashat Gabrail, M.D., has received notification from the U.S. Food and Drug Administration (FDA) that the investigator-initiated clinical trial may proceed under his Investigational New Drug (IND) application, evaluating STAR-LLD in combination with elranatamab in patients with relapsed or refractory multiple myeloma.
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T-cell engager therapies, including BCMA-directed bispecific antibodies such as elranatamab, have become an increasingly important treatment option in multiple myeloma and lymphoma. Unlike CAR-T cell therapies, which require specialized centers and complex administration, T-cell engagers can be administered in community oncology settings under controlled conditions, potentially making them accessible to a broader patient population.
Despite meaningful response rates, many patients eventually experience disease progression, with emerging evidence implicating declining T-cell fitness and T-cell exhaustion as potential contributors to acquired resistance. IMiDs present an opportunity to favorably modulate the tumor microenvironment potentially enhancing the depth and durability of response. Addressing these limitations is a primary clinical objective of the study. Enrollment is anticipated to begin in Q4 2026 subject to required approvals and requirements.
Immunomodulatory drugs (IMiDs) have demonstrated the potential to enhance the activity of T-cell engager therapies. However, combining standard oral lenalidomide with T-cell engagers may increase hematologic toxicity and infection risk, leading to IMiD dose reductions, treatment interruptions and discontinuations that can limit the potential benefit of the combination.
Nashat Gabrail, M.D., of Gabrail Cancer Center, said, “A major limitation of combining immunomodulatory agents with T-cell engager therapies is additive hematologic toxicity, which can force dose reductions of the IMiD and undermine what we are trying to achieve. STAR-LLD’s controlled delivery profile gives us an opportunity to test whether we can preserve, or potentially improve, efficacy while reducing the hematologic toxicity burden and potentially extending how long patients respond to bispecific therapy. I’m excited about this combination’s potential.”
Carsten Bick, Chief Executive Officer of PhaseWell Research, added, “One of the most important things PhaseWell can do is put cutting-edge science in the hands of investigators like Dr. Gabrail, in community settings where patients who would never set foot in an academic medical center can still access it. This study is a perfect example of that: rigorous, investigator-initiated science delivered where patients actually live. That is the PhaseWell mission in action.”
The study will evaluate controlled low-dose delivery of lenalidomide, designed to maintain sustained lenalidomide exposure targeting the drug’s immunomodulatory activity while intended to produce lower peak concentrations associated with conventional oral dosing. Building on clinical and scientific evidence evaluating IMiD and CELMoD combinations with T-cell engager therapies, the study will assess whether the combination can improve the therapeutic profile through sustained immune modulation with a lower hematologic toxicity burden.
Carrie Smith, RN, Chief Operations Officer of the Research Division, commented, “Conducting this study at the Gabrail Cancer and Research Center reflects the clinical reality of how T-cell engager therapies are increasingly used. Many multiple myeloma patients in the United States receive treatment in community oncology practices rather than academic medical centers. Generating safety and efficacy data in that setting, with a patient population reflecting everyday clinical practice, is important.”
About Gabrail Cancer Center
The Gabrail Cancer and Research Center, a PhaseWell Research site, is based in Canton, Ohio, and provides comprehensive cancer care and conducts clinical research across a broad range of hematologic and solid tumor malignancies. Led by Nashat Gabrail, M.D., the Center is committed to bringing novel investigational therapies to patients in a community oncology setting.
To learn more, visit www.gabrailcancercenter.com. Media inquiries may be directed to Carrie Smith at csmith@gabrailcancercenter.com.
About PhaseWell Research
PhaseWell Research is a multisite clinical research organization operating wholly owned investigator-led sites across the United States. The company partners with sponsors and CROs to support Phase I–IV clinical trials across complex, high-demand therapeutic areas, including oncology, central nervous system, and cardiometabolic conditions. Rooted in the communities it serves, PhaseWell expands access to advanced clinical research for patients who may otherwise have limited opportunities to participate. The network has completed more than 2,700 clinical trials and contributed to the approval of more than 200 therapies. For more information, visit www.phasewell.com.
STAR-LLD and its use in combination with elranatamab are investigational. FDA clearance to proceed reflects the absence of a clinical hold after the required safety review and does not constitute FDA approval or an assessment of the combination’s safety or efficacy. The safety and effectiveness of the combination have not been established, and the combination has not been approved by FDA.
This press release contains forward-looking statements, including statements regarding the design, timing, and anticipated enrollment of the investigator-initiated study, the potential benefits of combining STAR-LLD with elranatamab, and the study’s ability to affect response durability or hematologic toxicity. Words such as “anticipated,” “may,” “potential,” “designed to,” “intended,” “opportunity,” and similar expressions are intended to identify forward-looing statements. These statements are based on current expectations and assumptions and are subject to risks and uncertainties, including risks related to clinical trial enrollment, conduct, and results; regulatory review; and the fact that the combination of STAR-LLD and elranatamab is investigational, has not been approved by the FDA, and its safety and effectiveness have not been established. Actual results may differ materially from those expressed or implied by these statements. Gabrail Cancer Center and PhaseWell Research undertakes no obligation to update these statements except as required by law.
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