Is NCT06287528 recruiting in New York, NY?

Yes, NCT06287528 is currently recruiting participants at its New York, NY location. This philadelphia-negative all clinical trial is actively enrolling qualified participants.

How do I join the philadelphia-negative all clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Philadelphia-Negative ALL Clinical Trial in New York, NY

About This Philadelphia-Negative ALL Study in New York

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.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06287528) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Philadelphia-Negative ALL Treatment Options in New York, NY

If you're searching for philadelphia-negative all treatment options in New York, NY, this clinical trial (NCT06287528) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced philadelphia-negative all specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all philadelphia-negative all clinical trials near you to find additional studies recruiting in your area.

Philadelphia-Negative ALL Clinical Trial in New York, NY

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IRB Approved

No-Cost Care

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