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
