Actively Recruiting
Phase I Trial of 19-28z/IL-18 CAR T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-10
18
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new CAR T-cell therapy called 19-28z/IL-18 for adults and adolescents with relapsed or refractory acute lymphoblastic leukemia (ALL), including Philadelphia chromosome-negative and positive types. This Phase I trial aims to study the safety and toxicity of this investigational treatment in patients who have not responded to previous therapies or have relapsed. The study is led by Memorial Sloan Kettering Cancer Center and focuses on patients aged 17 years and older. Participants will have their white blood cells collected through leukapheresis, and these T cells will be modified in a laboratory to create the 19-28z/IL-18 CAR T-cell therapy over 2 to 4 weeks. Participants will receive one of three dose levels of CAR T cells, with or without lymphodepleting chemotherapy, to evaluate different dosing strategies. The study is non-randomized and open-label, meaning all participants know which dose they receive. During the study, researchers will monitor participants closely for toxicity and side effects up to 4 weeks using standard criteria. Patients will have various assessments including blood tests and organ function evaluations before and after treatment. The study includes patients with prior stem cell transplants and allows certain prior therapies if conditions are met. Overall participation length and follow-up beyond 4 weeks are not specified but safety and response will be carefully evaluated during the trial.
CONDITIONS
Brief Title
A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have relapsed or refractory acute lymphoblastic leukemia (ALL) meeting specific criteria based on Philadelphia chromosome status
- For Philadelphia-negative B-ALL: refractory or relapsed after at least one prior multiagent chemotherapy including induction and consolidation
- For Philadelphia-positive B-ALL: persistent or progressive disease after at least one second- or third-generation tyrosine kinase inhibitor
- Signed informed consent before study procedures
- Age 17 years or older for the first 6 patients; additional patients aged 12 years or older
- CD19 positivity confirmed on leukemia cells if prior anti-CD19 treatment received
- Prior allogeneic stem cell transplant allowed if at least 3 months prior and no recent graft versus host disease
- Donor lymphocyte infusions allowed if at least 4 weeks before leukapheresis
- Secondary CNS involvement allowed if not the only disease site and no neurologic symptoms
- Adequate organ function and performance status as defined
- Prior CD19-targeted therapies allowed with confirmed CD19 positivity
You will not qualify if you...
- Active malignancy other than certain treated skin or localized solid tumors with low recurrence risk
- Burkitt's leukemia or lymphoma or chronic myeloid leukemia in lymphoid blast crisis
- Active or symptomatic CNS disease or CNS 3 disease
- Recent use of therapeutic corticosteroids or systemic chemotherapy before leukapheresis or CAR T-cell infusion
- Significant recent cardiac conditions or heart failure
- Significant autoimmune or inflammatory CNS diseases
- Recent systemic treatment for graft versus host disease
- Known severe autoimmune diseases likely needing immunosuppressive medication
- HIV infection
- Active hepatitis B or C infection
- Uncontrolled infections including COVID-19 at key treatment times
- Other uncontrolled medical, psychological, social, or logistical conditions interfering with study compliance
- Recent live attenuated vaccine within 4 weeks before leukapheresis
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants receive 19-28z/IL-18 CAR T cells at varying dose levels to treat relapsed or refractory acute lymphoblastic leukemia.
1 baseline visit and multiple visits during CAR T cell treatment period
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
J
Jae Park, MD
M
Mark Geyer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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