Actively Recruiting
A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-10
18
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 specified criteria for Philadelphia chromosome positive or negative disease
- Signed informed consent form before any study procedures
- Age 17 years or older for the first 3 patients, then age 12 years or older for additional patients
- Documentation of CD19 positivity on leukemia cells if prior anti-CD19 treatment
- History of 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
- History of secondary CNS or meningeal involvement allowed if not the only site of disease and no neurological symptoms
- Adequate organ function including liver enzymes, bilirubin, kidney function, oxygen saturation, and heart function
- ECOG performance status 0-1 or Lansky score 60 or higher for patients under 16 years
- Prior CD19-targeted therapies allowed if CD19 positivity confirmed
You will not qualify if you...
- Active malignancy other than nonmelanoma skin cancer or low-risk localized solid tumors
- Burkitt's leukemia, lymphoma, or CML in lymphoid blast crisis
- Active or symptomatic CNS disease with high white blood cell count in cerebrospinal fluid
- Use of high-dose corticosteroids or systemic chemotherapy close to leukapheresis or CAR T cell infusion
- History of severe heart conditions or recent cardiac events within 6 months
- Significant autoimmune or inflammatory CNS disease
- Recent systemic treatment for graft versus host disease
- Known severe autoimmune diseases likely requiring immune suppression
- HIV infection
- Active hepatitis B or C infection
- Uncontrolled systemic infections including COVID-19 at time of leukapheresis or infusion
- Other uncontrolled medical, psychological, social, or logistical issues interfering with study compliance
- Treatment with live, attenuated vaccines within 4 weeks prior to leukapheresis
- Pregnant or lactating/breastfeeding women
AI-Screening
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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
CONTACT
M
Mark Geyer, MD
CONTACT
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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