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

NCT06287528 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 23-307
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

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); Refractory Acute Lymphoid Leukemia in Relapse

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

Outcome Measures

Primary Outcomes (1)

• Toxicity as determined by CTCAE, version 5.0

  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.

  4 weeks

Study Arms (3)

Dose Level 1

EXPERIMENTAL

0.5x106 CAR-T cell/kg without lymphodepleting chemotherapy (LDC)

Biological: 19-28z/IL-18 CAR T cells

Dose Level 2

EXPERIMENTAL

0.5x106 cells/kg with lymphodepleting chemotherapy (LDC)

Biological: 19-28z/IL-18 CAR T cells

Dose Level 3

EXPERIMENTAL

1x106 cells/kg with lymphodepleting chemotherapy (LDC)

Biological: 19-28z/IL-18 CAR T cells

Interventions

19-28z/IL-18 CAR T cells BIOLOGICAL

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

Dose Level 1; Dose Level 2; Dose Level 3

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jae Park, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Park, MD

CONTACT

646-608-3743; parkj6@mskcc.org

Mark Geyer, MD

CONTACT

646-608-3745; geyerm@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: February 23, 2024
• Primary Completion (Estimated): February 23, 2028
• Study Completion (Estimated): February 23, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)