RecruitingEarly Phase 1NCT06398457

Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies

A Pilot Study of Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

8 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Lymphoma Hematologic Malignancy Aplastic Anemia Acute Myeloid Leukemia (AML)Bone Marrow Transplant Rejection Myelodysplastic Syndromes (MDS)Acute Lymphoblastic Leukemia (ALL), Adult

Summary

This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a stem cell transplant.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests giving daratumumab (Darzalex Faspro) — a drug commonly used for multiple myeloma — before standard desensitization therapy in kidney transplant candidates who are "highly sensitized," meaning their immune system has developed antibodies that make it very hard to find a compatible donor. **You may be eligible if...** - You are awaiting a kidney transplant and have been identified as highly sensitized (high levels of antibodies against potential donors) - You are scheduled to undergo desensitization treatment before transplant - You are at least 18 years old - You do not have an active infection or cancer **You may NOT be eligible if...** - You have multiple myeloma or another plasma cell disorder - You have a serious infection or active cancer requiring treatment - You have previously received daratumumab - You have significant heart or lung problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarzalex Faspro (Daratumumab and hyaluronidase-fihj)

Darzalex Faspro will be administered weekly as a subcutaneous injection on Days -42, -35, -28 and -21 (+/- 1 day) for a total of four doses at 1800 mg each.

DEVICEJH-DSA Semi-Quant Screen and Response Score

Serum based semi-quantifiable investigational testing regimen used to screen for high DSA level or assess response to desensitization. It is based on results from cross-matched flow cytometric assessment cellular-based and solid phase immunoassays (SPI) that estimates antibody level.