Recruiting
Phase 1

19-28z/IL-18

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06287528

Conditions

Philadelphia-Negative ALL

Philadelphia-Positive ALL

Relapsed ALL, Adult

Refractory Acute Lymphoblastic Leukemia

Refractory Acute Lymphoblastic Leukemia (ALL)

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

19-28z/IL-18 CAR T cells

Study Details

Brief summary:

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

Philadelphia-Negative ALL

Philadelphia-Positive ALL

Relapsed ALL, Adult

Refractory Acute Lymphoblastic Leukemia

Refractory Acute Lymphoblastic Leukemia (ALL)

Study ID

NCT06287528

Start date

Feb 23, 2024

Status verified date

Feb, 2026

Completion date

Feb 23, 2028

Anticipated

Primary completion date

Feb 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

19-28z/IL-18 CAR T cells

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jae Park, MD

646-608-3743parkj6@mskcc.org

Mark Geyer, MD

646-608-3745geyerm@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jae Park, MD

646-608-3743

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jae Park, MD

646-608-3743

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jae Park, MD

646-608-3743

Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Jae Park, MD

646-608-3743

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jae Park, MD

646-608-3743

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jae Park, MD

646-608-3743

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Jae Park, MD

646-608-3743

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Philadelphia-Negative ALL
  • Philadelphia-Positive ALL
  • Philadelphia chromosome negative (Ph-negative) B-ALL
  • Philadelphia chromosome positive (Ph+ positive) B-ALL
  • Relapsed ALL, Adult
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Acute Lymphoblastic Leukemia (ALL)
  • Refractory Acute Lymphoid Leukemia in Relapse
  • 19-28z/IL-18
  • 23-307
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-02-10.