Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06623630
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Standard of care
  • Ciltacabtagene Autoleucel — DRUG
    Standard of care
  • Total body irradiation — RADIATION
    Radiation doses delivered to the entire body

Study Details

Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal function, leading to an urgent, unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population. In addition, renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations. This study is testing the hypotheses that: 1. low-dose total body irradiation (TBI) in combination with cyclophosphamide (Cy) as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function 2. low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansion/persistence and disease response rates as those seen with standard lymphodepleting chemotherapy (fludarabine / cyclophosphamide).

Key Dates

Start date
Dec 4, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cyclophosphamide + Cilta-Cel + TBI
    All patients will undergo T-cell collection and CAR T manufacturing as per standard of care. Patients will receive cyclophosphamide per standard of care Day -5 to Day -3. They will subsequently receive TBI on Day -1 then and will receive cilta-cel infusion on Day 0.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Through 28 days post cilta-cel ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Michael J Slade, M.D., MSCI
[email protected]
314-454-8304
Michael J Slade, M.D., MSCI (PRINCIPAL_INVESTIGATOR)
Zachary Crees, M.D. (SUB_INVESTIGATOR)
Keith Stockerl-Goldstein, M.D. (SUB_INVESTIGATOR)
Nathan Singh, M.D., M.S. (SUB_INVESTIGATOR)
Miriam Y Kim, M.D. (SUB_INVESTIGATOR)
Joanna C Yang, M.D., M.P.H. (SUB_INVESTIGATOR)
Ravi Vij, M.D. (SUB_INVESTIGATOR)
Mark Schroeder, M.D. (SUB_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Washington University School of Medicine· St Louis, MO

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