A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)

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

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06287528
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Philadelphia-Negative ALL
  • Philadelphia-Positive ALL
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Acute Lymphoblastic Leukemia (ALL)
  • Refractory Acute Lymphoid Leukemia in Relapse
  • Relapsed ALL, Adult

Eligibility Criteria

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

Interventions

  • 19-28z/IL-18 CAR T cells — BIOLOGICAL
    19-28z/IL-18 CAR T cells are an investigational new drug (IND) for the treatment of R/R B-ALL

Study Details

Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks.

Key Dates

First listed
Mar 1, 2024
Start date
Feb 23, 2024
Status verified
Feb 2026
Primary completion
Feb 23, 2028
Completion
Feb 23, 2028

Study Design

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

Arms

  • Experimental: Dose Level 1
    0.5x106 CAR-T cell/kg without lymphodepleting chemotherapy (LDC)
  • Experimental: Dose Level 2
    0.5x106 cells/kg with lymphodepleting chemotherapy (LDC)
  • Experimental: Dose Level 3
    1x106 cells/kg with lymphodepleting chemotherapy (LDC)

Primary Outcome Measure

Toxicity as determined by CTCAE, version 5.0 [ Time Frame: 4 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Jae Park, MD
646-608-3743

Find similar trials in Basking Ridge, NJ

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 Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

Related Studies