Is NCT04881240 recruiting in Memphis, TN?

Yes, NCT04881240 is currently recruiting participants at its Memphis, TN location. This acute lymphoblastic leukemia, in relapse clinical trial is actively enrolling qualified participants.

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.

Acute Lymphoblastic Leukemia, in Relapse Clinical Trial in Memphis, TN

Q: How do I join the acute lymphoblastic leukemia, in relapse 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.

About This Acute Lymphoblastic Leukemia, in Relapse Study in Memphis

This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old with relapsed and/ or refractory CD19-positive leukemia. Primary Objective To determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with allogeneic CD19-CAR.CD45RA-negative T-cells in pediatric, adolescent and young adult patients ≤ 21 years of age, with relapsed and/or refractory CD19-positive leukemia. Secondary Objectives * To evaluate the anti-leukemic activity of allogeneic CD19-CAR.CD45RA-negative T-cells. * To determine rates and severity of graft-versus-host-disease (GVHD) after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells. Exploratory Objectives * To study the expansion, persistence and phenotype of allogeneic CD19-CAR.CD45RA-negative T-cells. * To characterize the cytokine profile in the peripheral blood and CSF after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells. * To assess whether allogeneic CD19-CAR.CD45RA-negative T-cells acquire functional versus exhaustion-associated epigenetic programs. * To determine immune reconstitution post treatment, and the clonal structure and endogenous repertoire of allogeneic CD19-CAR.CD45RA-negative T-cells and relate inferred specificity to CAR response profiles. * To characterize incidence and mechanisms of relapse post-therapy with allogeneic CD19-CAR.CD45RA-negative T-cells.

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

Eligibility Criteria for Donors: Apheresis and Manufacturing

Age ≥ 18 years old

At least single haplotype matched (≥ 3/6) family member

HIV negative

For females of child bearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND Not lactating with intent to breastfeed

Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance For Cohort A only, identified recipient with relapsed and/or refractory CD19-positive leukemia For Cohort B only, iIdentified recipient with relapsed and/or refractory CD19-positive leukemia who is not suitable to receive autologous CD19-CAR T-cell therapy as defined by the following:

Relapsed and/or refractory disease despite prior treatment with autologous CD19- CAR T-cell therapy

History of prior autologous leukapheresis failure

History of prior autologous CAR T-cell manufacturing failure

Unable to undergo autologous leukapheresis in the opinion of the study PI(s): examples may include - patient small size/low weight, inadequate T-cell counts, rapidly progressive leukemia, clinical status not amenable to apheresis Eligibility Criteria for Patients: Treatment

Age ≤ 21 years old

Relapsed and/or refractory CD19-positive leukemia\*:

Refractory disease (defined as any of the following):

Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission

Refractory disease despite salvage therapy

Relapsed disease (defined as any of the following):

2nd or greater relapse

Any relapse after allogeneic hematopoietic cell transplantation (HCT)

1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT CD19-positivity confirmed within 2 months and after receipt of any CD19-directed therapy

Patient cohorts:

Cohort A: patient has previously received a HCT from the selected CAR T-cell donor

Cohort B - patient has NOT previously received a HCT from the selected CAR T-cell donor.

For Cohort B only, not suitable to receive autologous CD19-CAR T-cell therapy as defined above in Criteria: Eligibility Criteria for Donors: Apheresis and Manufacturing

Detectable medullary CD19-positive leukemia

Estimated life expectancy of ≥ 8 weeks

Karnofsky or Lansky performance score ≥ 50

No CNS-3 disease or any level of detectable leukemia in CNS with associated neurologic symptoms

If history of allogeneic HCT (regardless of donor type), prior to planned CAR T-cell infusion, must meet the following criteria:

≥ 3 months from HCT

have recovered from prior HCT therapy

have no evidence of active GVHD within prior 2 months

have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned CAR T-cell infusion

Adequate cardiac function: left ventricular ejection fraction ≥ 40% or shortening fraction ≥ 25% (function may be supported by pharmacologic therapy)

EKG without evidence of clinically significant arrhythmia

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

Adequate pulmonary function: 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

No history of HIV infection

No evidence of severe, uncontrolled bacterial, viral or fungal infection

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

For females of child bearing age:

Not pregnant with negative serum or urine pregnancy test ≤ 7 days prior to enrollment AND Not lactating with intent to breastfeed

If sexually active, agreement to use birth control until 6 months after CAR T-cell infusion

No history of hypersensitivity reactions to murine protein-containing products

Not receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone ≤ 7 days prior to CAR T-cell infusion

Not receiving systemic therapy ≤ 14 days prior to CAR T-cell infusion, which will interfere with the activity of the CAR T-cell product in vivo (in the opinion of the study PI(s))

Not receiving intrathecal chemotherapy ≤ 7 days prior to CAR T-cell infusion

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 (NCT04881240) 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.

Acute Lymphoblastic Leukemia, in Relapse Treatment Options in Memphis, TN

If you're searching for acute lymphoblastic leukemia, in relapse treatment options in Memphis, TN, this clinical trial (NCT04881240) 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 phase 1 clinical trial. You'll receive care from experienced acute lymphoblastic leukemia, in relapse 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 acute lymphoblastic leukemia, in relapse clinical trials near you to find additional studies recruiting in your area.

Acute Lymphoblastic Leukemia, in Relapse Clinical Trial in Memphis, TN

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