Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• WS-CART-CS1 — BIOLOGICAL
  -Subject will be hospitalized for 7 days
• Lymphodepleting chemotherapy — DRUG
  * Cyclophosphamide 500 mg/m\^2 IV on Days -5, -4, and -3 * Fludarabine 30 mg/m\^2 IV on Days -5, -4, and -3

Study Details

Despite recent therapeutic advances, multiple myeloma (MM) remains an incurable disease. Although survival has improved, there are nevertheless diminishing durations of response to each subsequent line of therapy. This highlights the need for further therapeutic innovation. BCMA-targeting CAR-T cells show impressive response rates; however, their median duration of response is disappointing. The investigators propose that CS1(SLAMF7)-targeting CAR-T cells will fill a gap in the MM armamentarium. CS1 is an attractive target in MM because it is expressed in most patients. Elotuzumab (Empliciti®), an approved anti-CS1 antibody, has proven the clinical efficacy of this target. CAR-T cells are an ideal modality to target CS1, given that two approved treatments, ide-cel (idecabtagene vicleucel, AbecmaTM) and cilta-cel (ciltacabtagene autoleucel, Carvykti™), have proven the potential for cellular immunotherapy in MM. The investigators are testing the safety and preliminary anti-myeloma efficacy of WS-CART-CS1, a CAR-T cell therapy targeting CS1.

Key Dates

Start date

Aug 22, 2024

Status verified

Apr 2026

Primary completion

Aug 31, 2029

Completion

Aug 31, 2040

Study Design

Enrollment

25 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A Dose Escalation: WS-CART-CS1
  * Undergo apheresis procedure for WS-CART-CS1 manufacturing. * Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician. * Lymphodepleting chemotherapy on days -5, -4, and -3. * Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused. * Part A is the dose escalation portion of the study with the starting dose of 0.5 x 10\^6 cells/kg of WS-CART-CS1.
• Experimental: Part B Dose Expansion: WS-CART-CS1
  * Undergo apheresis procedure for WS-CART-CS1 manufacturing. * Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician. * Lymphodepleting chemotherapy on days -5, -4, and -3. * Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused. * Part B is the dose expansion portion of the study. The dose of WS-CART-CS1 will be determined in Part A of the study.

Primary Outcome Measure

Part A: Frequency and severity of treatment-emergent adverse events [ Time Frame: From leukapheresis through 24 months after WS-CART-CS1 infusion (approximately 24 months and 1 week) ]

Central Contacts

• Armin Ghobadi, M.D.
  314-747-2743
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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