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

Recruiting now · Phase 1

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

In brief

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 facts

Study ID: NCT06287528
Run by: Memorial Sloan Kettering Cancer Center
People needed: 18
Starts: 2024-02-23
Expected to finish: 2028-02-23
Last updated by the study team: 2026-02-10

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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