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Acute Lymphoblastic Leukemia, in RelapsePhase 1NCT04881240

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

A Phase 1 study testing CD19-CAR(Mem) T-cells, Cyclophosphamide and Fludarabine in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory, run by St. Jude Children's Research Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
CD19-CAR(Mem) T-cells, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
14 Feb 2024to 1 Jul 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • MEMCAR19 recipient candidate ≤<21 years old with rRelapsed and/or refractory CD19-positive leukemia.
  • Due to potential scheduling challenges, all recipients may not be offered the Pre-Treatment Evaluation consent. This will not be counted as a deviation.
  • Eligibility Criteria for Patients:Treatment
  • Age ≤ 21 years old
  • Relapsed and/or refractory CD19-positive leukemia*:
  • Refractory disease (defined as any of the following):
Show all 42Show fewer
  • 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

Who cannot join

  • NA

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aimee C. Talleur, MD contact

866-278-5833

referralinfo@stjude.org

United States1 site, 1 recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Aimee C. Talleur, MD, 866-278-5833, referralinfo@stjude.org

    Aimee C. Talleur, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase I Study Evaluating Allogeneic Memory T Cells Engineered to Express Chimeric Antigen Receptors Specific for CD19 for the Treatment of Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19-Positive Leukemia

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

Read more

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.
Read the detailed description

This is a Phase I dose escalation study using a 3+3 study design. Two groups of patients will be evaluated in this study: group A - patients have received a prior stem cell transplant from their CAR T-cell donor; group B - patients have not received a prior stem cell transplant from their CAR T-cell donor. There will be up to 30 participants per group and a donor/ family member for each patient.

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Being tested
CD19-CAR(Mem) T-cells, Cyclophosphamide, Fludarabine, Mesna, CliniMACS
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19-CAR(Mem) T-cellsBiological

    Allogeneic CD19-CAR.CD45RA-negative T-cells Intravenous infusion

  • CyclophosphamideDrug

    Also called Cytoxan

    Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.

  • FludarabineDrug

    Also called Fludara

    Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.

  • MesnaDrug

    Also called Mesnex

    Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide.

  • CliniMACSDevice

    A CliniMACS device is used to select donor T-cells for manufacturing of the memory CAR T-cell product.

  • LeukapheresisProcedure or surgery

    Leukapheresis is performed to collect the T cells that are needed to generate the CD19-CAR.CD45RA-negative T-cells product for the clinic study.

Study groups in NCT04881240
Study groupRoleWhat they receive
Group AExperimentalParticipants in group A have received a prior stem cell transplant from their CAR T-cell donor.
Receives: Biological: CD19-CAR(Mem) T-cells; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Device: CliniMACS; Procedure: Leukapheresis
Group BExperimentalParticipants in group B have not received a prior stem cell transplant from their CAR T-cell donor.
Receives: Biological: CD19-CAR(Mem) T-cells; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Device: CliniMACS; Procedure: Leukapheresis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 4 weeks after CAR T-cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start14 Feb 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881240
Sponsor's protocol ID
MEMCAR19
Other IDs
NCI-2021-04591
Status last verified
Aug 2026
First submitted
27 Apr 2021
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19-CAR(Mem) T-cells, Cyclophosphamide and Fludarabine in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory, run by St. Jude Children's Research Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aimee C. Talleur, MD (866-278-5833, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of allogeneic, CD19-CAR.CD45RA-negative cells (time frame: 4 weeks after CAR T-cell infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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