A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06017258
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse
  • Refractory Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD371-specific/YSNVz/I-18 CAR T cells — BIOLOGICAL
    Cohorts will be infused with escalating doses of CD371-specific/YSNVz/IL-18 CAR T cells with lymphodepleting chemotherapy (LDC) to establish the maximum tolerated dose (MTD). There is a third, lower dose level (step-down dose) available for dose de-escalation in the event of severe toxicity at the first planned dose level.

Study Details

The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.

Key Dates

Start date
Aug 22, 2023
Status verified
Feb 2026
Primary completion
Aug 22, 2026
Completion
Aug 22, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
  • Experimental: Dose Level 2
    Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
  • Experimental: Step-Down Dose
    Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of CAR T cells [ Time Frame: up to 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)CommackNew York11725
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Cancer Center (All protocol activites)New YorkNew York10065
Mark Geyer, MD
646-608-3745
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Mark Geyer, MD
646-608-3745

Find similar trials in Basking Ridge, NJ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All protocol activites)· New York, NY

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