Gabrail Cancer Center Undertakes Investigator-Initiated Study Evaluating the T-Cell Engager Elranatamab Plus Star-LLD

Trial led Nashat Gabrail, M.D., will assess dose-finding, safety and preliminary efficacy of STAR-LLD plus elranatamab in RRMM.

CANTON, OH, UNITED STATES, August 25, 2026 /EINPresswire.com/ -- The Gabrail Cancer Center Undertakes Investigator-Initiated Study Evaluating the T-Cell Engager Elranatamab in Combination with Starton Therapeutics’ Controlled Low-Dose Lenalidomide

Trial led by Nashat Gabrail, M.D., will assess dose-finding, safety and preliminary efficacy of STAR-LLD alongside elranatamab in relapsed or refractory multiple myeloma

Study aims to improve durability and depth of response to T-cell engager therapy while reducing the hematologic toxicity associated with standard IMiD combinations

The Gabrail Cancer and Research Center 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.

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, patients treated with T-cell engagers eventually progress, 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.

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.”

The study will evaluate controlled low-dose delivery of lenalidomide, designed to maintain sustained lenalidomide exposure targeting the drug’s immunomodulatory activity while avoiding the high 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, based in Canton, Ohio, 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 or contact Carrie Smith at csmith@gabrailcancercenter.com.

Carrie Smith
Gabrail Cancer Center Research
+1 330-417-8231
csmith@gabrailcancercenter.com
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