Study of CD19 Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia

This study is looking at a new treatment for children and young adults (up to 21 years old) with leukemia that has come back or hasn't responded to other treatments. The treatment uses special immune cells called CD19-CAR(Mem) T-cells, which come from a donor. These cells are designed to find and fight leukemia cells. Before receiving the T-cells, participants will get chemotherapy drugs called Cyclophosphamide and Fludarabine, along with Mesna to protect the bladder. The main goal is to find the safest dose of these T-cells and understand any side effects. The study is currently recruiting up to 60 participants.

Study design: This is a Phase I study designed to find the maximum tolerated dose of the treatment. It will include up to 60 participants, divided into two groups based on whether they've had a prior stem cell transplant from the same donor.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, maximum tolerated dose, is measured at 4 weeks after CAR T-cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Study of CD19 Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia

Recruiting

PHASE1Up to 21InterventionalTreatment

St. Jude Children's Research Hospital

~60 participants

Updated 2026-08-31 on ClinicalTrials.gov

What's tested:CD19-CAR(Mem) T-cellsCyclophosphamideFludarabineMesnaCliniMACSLeukapheresis

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Maximum tolerated dose of allogeneic, CD19-CAR.CD45RA-negative cells

Measured over 4 weeks after CAR T-cell infusion

Conditions

Acute Lymphoblastic Leukemia, in Relapse

Acute Lymphoblastic Leukemia, Refractory

Pediatric ALL

NCT04881240

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

St. Jude Children's Research Hospital
Memphis, Tennesseestudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Aimee C. Talleur, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Stephen Gottschalk, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Aimee C. Talleur, MD

[email protected]

866-278-5833

Email the study team

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Eligibility criteria

Inclusion

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, an ineligible donor may be used under urgent medical need if the reason for ineligibility was previously present at time of transplant determination.

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

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

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

What this trial measures

Maximum tolerated dose of allogeneic, CD19-CAR.CD45RA-negative cells4 weeks after CAR T-cell infusion
This phase I study includes dose escalation/de-escalation based on dose limiting toxicity (DLT) assessment to determine the maximum tolerated dose (MTD) of allogeneic, CD19-CAR.CD45RA-negative cells.

Trialytics