A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)
A Phase I Trial of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells That Constitutively Secrete Interleukin 18 (19-28z/IL-18) in Patients With Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 17 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests 19-28z/IL-18, a CAR T-cell therapy, for people with acute lymphoblastic leukemia (ALL) that came back or did not respond to treatment. T cells, a type of white blood cell, are collected from each person and changed in a lab to make the treatment. This takes about 2–4 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have B-cell ALL that came back or did not respond to treatment. People without the Philadelphia chromosome change must have had at least one multi-drug chemotherapy plan with both starting and follow-up treatment.
- People with the Philadelphia chromosome change must have leukemia that stayed or grew after at least one newer targeted drug called a second- or third-generation tyrosine kinase inhibitor.
- The first 3 patients must be at least 17. If a side effect that limits treatment occurs, the next 3 must also be at least 17. Later patients may be 12 or older.
- Sign a consent form before any study procedures.
- Past CD19-targeted treatment, including CAR T-cell therapy, is allowed if the latest bone marrow, blood, or tumor test shows the leukemia cells still have the CD19 marker.
- A past donor stem cell transplant is allowed if it was at least 3 months before joining, with no graft-versus-host disease (donor cells attacking the body) in the past 4 weeks. Donor immune cell infusions must be at least 4 weeks before T-cell collection.
- Past leukemia in the brain, spinal cord, or their lining is allowed if it is not the only disease site and there are no nervous system symptoms.
- Meet the study's liver, kidney, lung, and heart test limits and its limits for daily activity. Children under 16 have a separate activity score requirement.
Who can't join
- Have another active cancer, except certain skin cancers or a treated cancer with a low chance of returning. Burkitt leukemia or lymphoma and a certain advanced form of chronic myeloid leukemia (CML) are also excluded.
- Have leukemia in the brain or spinal cord seen on scans, causing symptoms, or meeting the study's spinal fluid test limit. Successfully treated leukemia in these areas may be allowed.
- Use certain medicines too close to T-cell collection or treatment: steroids above the allowed dose, chemotherapy, or hydroxyurea. Timing limits range from 72 hours to 1 week. Live, weakened vaccines within 4 weeks before collection are also excluded.
- Have serious heart disease or certain heart procedures within the past 6 months.
- Have a major immune or inflammatory illness affecting the brain or spinal cord, or severe autoimmune disease likely to need medicines that weaken the immune system. Treatment throughout the body for graft-versus-host disease within 4 weeks also excludes you.
- Have HIV, active hepatitis B or C, or an uncontrolled infection, including COVID-19, when T cells are collected or given back.
- Have other uncontrolled health or mental health conditions, or social or travel problems, that the study doctor believes would prevent following study requirements.
- Are pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (7)
NJ
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, NJ 07920Jae Park, MD · Study contact · 646-608-3743More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, NJ 07748Jae Park, MD · Study contact · 646-608-3743More trials in Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, NJ 07645Jae Park, MD · Study contact · 646-608-3743More trials in Montvale
NY
- Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities) · Commack, NY 11725Jae Park, MD · Study contact · 646-608-3743More trials in Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, NY 10604Jae Park, MD · Study contact · 646-608-3743More trials in Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, NY 10065Jae Park, MD · Study contact · 646-608-3743More trials in New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) · Uniondale, NY 11553Jae Park, MD · Study contact · 646-608-3743More trials in Uniondale