Study of 19-28z/IL-18 for Acute Lymphoblastic Leukemia (ALL)
This study is testing a new cell therapy called 19-28z/IL-18 CAR T cells for people with acute lymphoblastic leukemia (ALL) that has come back (relapsed) or hasn't responded to previous treatments (refractory). This therapy uses your own white blood cells, called T cells, which are collected and then changed in a lab to fight cancer. This process takes about 2-4 weeks. The study is looking at how safe this treatment is, specifically checking for side effects. You may be able to join if you are 17 years or older and have certain types of relapsed or refractory ALL, including Philadelphia-negative or Philadelphia-positive ALL.
- Study design
- This interventional study plans to enroll 18 participants. It is testing a single treatment, 19-28z/IL-18 CAR T cells.
- What's involved
- You will have your white blood cells collected through a procedure called leukapheresis. These cells will then be modified to create the study therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for toxicity is measured at 4 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06287528
A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)
Recruiting
PHASE1Ages 17+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~18 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:19-28z/IL-18 CAR T cells
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Toxicity as determined by CTCAE, version 5.0
Measured over 4 weeks
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Jae Park, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have R/R ALL meeting one of the following criteria:
For Philadelphia chromosome (Ph) negative B-ALL: Refractory or relapsed disease to at least 1 prior multiagent systemic chemotherapy regimen that included both induction and consolidation therapy
For Philadelphia chromosome (Ph) positive B-ALL: patients must have exhibited persistent or progressive disease following at least 1 prior second- or third-generation tyrosine kinase inhibitor
Signed informed consent form (ICF) prior to any study procedures
Age: The first 3 patients enrolled into the study will be ≥ 17 years of age at time of enrollment. If a DLT is observed, the additional 3 patients in this cohort will also be ≥ 17 years of age. Additional patients will be ≥12 years of age at time of enrollment.
Documentation of CD19 positivity on leukemia blasts if prior anti-CD19 treatment
History of prior allogeneic hematopoietic stem cell transplant (HSCT) is allowed if ≥3 months from time of enrollment and no evidence of acute or chronic graft versus host disease (GVHD) within 4 weeks prior to enrollment
Donor lymphocyte infusions (DLI) permitted if ≥4 weeks prior to leukapheresis
History of secondary CNS or meningeal involvement allowed if:
cannot be the only site of disease
absence of neurologic symptoms, such as: seizures, stroke-like deficits, altered mental status, aphasia, or psychosis
Adequate organ function at time of screening, including:
ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)
Serum creatinine \<2.0mg/100mL
SaO2 ≥92% on room air
Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening
ECOG performance status 0-1 or Lansky performance status ≥ 60 for patients \< 16 years old
Prior CD19-targeted therapies (including CD19 CAR-T cell and CD19 bispecific T-cell engagers) are allowed including anti-CD19 CAR T therapy, as long as CD19 positivity is confirmed on most recent bone marrow, blood or tumor biopsy
Exclusion
Concurrent active malignancy excluding: nonmelanoma skin cancer or localized solid tumor that has undergone definitive therapy and with low risk of recurrence, e.g., prostate, breast
Burkitt's leukemia or lymphoma or CML in lymphoid blast crisis
Radiologically detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5/µL WBCs in CSF). Subjects with adequately treated CNS leukemia are eligible.
The following medications are excluded:
Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.
Chemotherapy: Systemic chemotherapy should be stopped one week prior to leukapheresis or starting CAR T cell infusion or lymphodepleting chemotherapy. Hydroxyurea for cytoreduction can be administered up to 72 hours before leukapheresis or CAR T cell infusion.
History of class III-IV New York Heart Association (NYHA) heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac condition within 6 months of screening
Patients with history of significant autoimmune disease and/or inflammatory condition affecting the CNS are ineligible
Systemic treatment for GVHD within 4 weeks prior to enrollment
Patients with known severe autoimmune disease (e.g., Crohn's, rheumatoid arthritis, or lupus) that in the investigator's opinion has high likelihood of requiring systemic immune suppressive medications
Patients with HIV infection
Patients with active hepatitis B infection (as manifested by either detectable hepatitis B virus DNA by PCR and/or positivity for hepatitis B surface antigen)
Patients with active hepatitis C infection (as manifested by detectable hepatitis C virus RNA by PCR)
Patients with uncontrolled systemic fungal, bacterial, viral or other infection including COVID-19 at time of leukapheresis or at time of CAR T cell infusion.
Other uncontrolled medical or psychological conditions as well as social or logistical issues that may interfere with compliance with the protocol, as determined by the investigator
Treatment with live, attenuated vaccine \<4 weeks prior to leukapheresis
Pregnant or lactating/breastfeeding women
What this trial measures
- Toxicity as determined by CTCAE, version 5.04 weeks
The primary objective is to determine the safety of 19-28z/IL18 CAR T cells in patients with R/R ALL. Toxicity will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.