Is NCT04318678 recruiting in Memphis, TN?

Yes, NCT04318678 is currently recruiting participants at its Memphis, TN location. This aml/mds clinical trial is actively enrolling qualified participants.

How do I join the aml/mds clinical trial in Memphis?

To join this clinical trial in Memphis, 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 Memphis 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.

AML/MDS Clinical Trial in Memphis, TN

About This AML/MDS Study in Memphis

The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival. Primary Objective: * To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy. * To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy. Secondary Objectives \- To evaluate the antileukemia activity of CD123-CAR T cells. Exploratory Objectives * To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells * To characterize tumor cells post CD123-CAR T-cell therapy * To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

for Procurement and T-cell Production:

Age ≤21 years old

Relapsed/refractory CD123+ disease defined as follows: AML/MDS

Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)

Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy B-cell ALL

Relapsed disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies including

Patients in 2nd or greater relapse

Patients with relapse after allogeneic HSCT

Refractory disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies T-cell All • Relapsed refractory disease that is CD123 positive BPDCN • Relapsed/refractory disease that has failed front-line therapy

Estimated life expectancy of \>12 weeks

Karnofsky or Lansky (age-dependent) performance score ≥50

Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis

Patient must have an identified, suitable HCT donor

For females of child-bearing age:

Not lactating with intent to breastfeed

Not pregnant with negative serum pregnancy test within 7 days prior to enrollment

Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis

Exclusion Criteria

Known primary immunodeficiency

History of HIV infection

Severe intercurrent uncontrolled bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)

History of hypersensitivity reactions to murine protein-containing products

Patients with acute promyelocytic leukemia (APL, t (15;17))

Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide. Inclusion Criteria for Treatment:

Age≤21 years old

Detectable disease that is CD123+ (at least MRD+ disease)

Estimated life expectancy of \>8 weeks

Karnofsky or Lansky (age-dependent) performance score≥50

Patient must have an identified, suitable HCT donor

Adequate cardiac function defined as left ventricular ejection fraction \>40%, OR shortening fraction ≥25%

EKG without evidence of clinically significant arrhythmia

Adequate renal function defined as creatinine clearance or radioisotope GFR ≥50 ml/min/1.73m2 (GFR ≥40 ml/min/1.73m2 if \< 2 years of age)

Adequate pulmonary function defined as forced vital capacity (FVC)≥50% of predicted value; or pulse oximetry≥92% on room air if patient is unable to perform pulmonary function testing

Total Bilirubin≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome

Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age

Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy

For females of child-bearing age

Not lactating with intent to breastfeed

Not pregnant with negative serum pregnancy test within 7 days prior to enrollment

If sexually active, agreement to use birth control until 3 months after T- cell infusion. Male partners should use a condom.

Available autologous transduced T-cell product that has met GMP release criteria Exclusion Criteria:

Known primary immunodeficiency

History of HIV infection

Severe intercurrent uncontrolled bacterial, viral or fungal infection

History of hypersensitivity reactions to murine protein-containing products

History of severe hypersensitivity reactions to cornstarch or hydroxyethyl starch.

Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to CD123-CAR T- cell infusion

Receiving systemic therapy in the 14 days prior to CD123-CAR T-cell infusion, which will interfere with the activity of the CD123-CAR T cells in vivo (in the opinion of the study PI(s))

Receiving rituximab therapy in the 30 days prior to CD123-CAR T cell infusion. (This exclusion criterion is intended to prevent premature exposure of CD123-CAR T cells to rituximab, which would activate the safety switch and promote CAR T-cell apoptosis).

Receiving intrathecal chemotherapy in the 7 days prior to CD123-CAR T cell infusion.

Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide.

Active CNS disease

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 Memphis?

Yes, this clinical trial (NCT04318678) has an active research site in Memphis, TN 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.

AML/MDS Treatment Options in Memphis, TN

If you're searching for aml/mds treatment options in Memphis, TN, this clinical trial (NCT04318678) 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 Memphis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aml/mds 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 aml/mds clinical trials near you to find additional studies recruiting in your area.

AML/MDS Clinical Trial in Memphis, TN

Expert Care in Memphis

IRB Approved

No-Cost Care

Apply for This Memphis Location

Why Participate?

Simple Process