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

NCT ID: NCT06287528

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

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Recurrence

Conditions: 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

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: 19-28z/IL-18 CAR T cells
Description: 19-28z/IL-18 CAR T cells are an investigational new drug (IND) for the treatment of R/R B-ALL
Arm group label: Dose Level 1
Arm group label: Dose Level 2
Arm group label: Dose Level 3

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients must have R/R ALL meeting one of the following criteria: - For Philadelphia chromosome negative (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 positive (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 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: Should be stopped one week prior to leukapheresis or starting 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. For those patients who have had a recent COVID-19 infection, at least 4 weeks should be passed before the COVID-19 infection date and 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

Gender: All

Minimum age: 17 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Address:
City: Basking Ridge
Zip: 07920
Country: United States

Status: Recruiting

Contact:
Last name: Jae Park, MD

Phone: 646-608-3743

Facility:
Name: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Address:
City: Middletown
Zip: 07748
Country: United States

Status: Recruiting

Contact:
Last name: Jae Park, MD

Phone: 646-608-3743

Facility:
Name: Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Address:
City: Montvale
Zip: 07645
Country: United States

Status: Recruiting

Contact:
Last name: Jae Park, MD

Phone: 646-608-3743

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

Address:
City: Commack
Zip: 11725
Country: United States

Status: Recruiting

Contact:
Last name: Jae Park, MD

Phone: 646-608-3743

Facility:
Name: Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Address:
City: Harrison
Zip: 10604
Country: United States

Status: Recruiting

Contact:
Last name: Jae Park, MD

Phone: 646-608-3743

Facility:
Name: Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Jae Park, MD

Phone: 646-608-3743

Facility:
Name: Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Address:
City: Uniondale
Zip: 11553
Country: United States

Status: Recruiting

Contact:
Last name: Jae Park, MD

Phone: 646-608-3743

Start date: February 23, 2024

Completion date: February 23, 2028

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06287528
http://www.mskcc.org

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