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B Acute Lymphoblastic LeukemiaPhase 1NCT05707273

CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission

A Phase 1 study testing Autologous Anti-CD19 CAR-expressing T Lymphocytes, Biospecimen Collection and Bone Marrow Aspiration and Biopsy in people with B Acute Lymphoblastic Leukemia, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults with B-cell acute lymphoblastic leukemia. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
B Acute Lymphoblastic Leukemia
What is being tested?
Autologous Anti-CD19 CAR-expressing T Lymphocytes, Biospecimen Collection and Bone Marrow Aspiration and Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
26 Apr 2023to 21 Sep 2027
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with Study Principal Investigator (PI) approval
  • Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
  • Age: >= 55 years
  • Eastern Cooperative Oncology Group (ECOG) < 2 / Karnofsky Performance Status (KPS) >= 70
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  • Ability to read and understand English for Questionnaires
  • Histologically confirmed CD19+ ALL at the time of diagnosis
  • In morphological first complete remission regardless of minimal residual disease (MRD) status
  • No immediate plan for transplant
  • Remission after induction +/- reinduction therapy
  • Fully recovered from the acute toxic effects (except alopecia) to =< Grade 1 to prior anti-cancer therapy
  • Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)
  • Aspartate aminotransferase (AST) =< 3 x ULN
  • Alanine transaminase (ALT) =< 3 x ULN
  • Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
  • Left ventricular ejection fraction (LVEF) >= 50%
  • Note: To be performed within 28 days prior to start of protocol therapy
  • Oxygen (O2) saturation > 92% on room air.
  • Note: To be performed within 28 days prior to start of protocol therapy
  • Seronegative for human immunodeficiency virus (HIV) (quantitative polymerase chain reaction [qPCR]), hepatitis C virus (HCV), active hepatitis B virus (HBV) (Surface Antigen Negative), and syphilis (rapid plasma reagin [RPR])
  • If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR
  • If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
  • Meets other institutional and federal requirements for infectious disease titer requirements
  • Note Infectious disease testing to be performed within 28 days prior to start of protocol therapy
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent(s)
  • Research participant with known CNS-2 or CNS-3 involvement that is refractory to intrathecal chemotherapy and/or cranio-spinal radiation. Research participants with a history of central nervous system (CNS) disease that has been effectively treated to complete remission (<5 WBC/mm3 and no blasts in cerebrospinal fluid [CSF]) will be eligible
  • Autoimmune disease or active graft versus host disease (GVHD) requiring systemic immunosuppressant therapy
  • Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification
  • History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for >= 2 years
  • Clinically significant uncontrolled illness
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  • Active systemic uncontrolled infection requiring antibiotics
  • Known history of HIV or hepatitis B or hepatitis C infection
  • Subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded
  • Subjects who are hepatitis B core antibody positive (or have a known history of HBV infection) should be monitored quarterly with a quantitative PCR test for HBV deoxyribonucleic acid (DNA). HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core Ab positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment
  • Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded
  • Females only: Pregnant or breastfeeding
  • Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =< 7.5 mg /day or equivalent) is allowed
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Pilot Study of CD19-Specific Car T Cells as Consolidation for Older Adults With Acute Lymphoblastic Leukemia in First Remission

This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults with B-cell acute lymphoblastic leukemia. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of B-cell acute lymphoblastic leukemia.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Assess the safety and tolerability of autologous CD19-CAR T cell therapy by evaluation of toxicities including type, frequency, severity, attribution, time course and duration in older patients with B-cell acute lymphoblastic leukemia (ALL) in first morphological complete remission (CR1).

SECONDARY OBJECTIVES:

  1. Assess the feasibility of manufacturing and infusing CD19-CAR T cells in older adults with B-cell ALL in CR1.

II. Evaluate the rate of MRD- remission in patients who had MRD+ disease at the time of infusion.

III. Evaluate the overall risk of relapse. IV. Evaluate the risk of central nervous system (CNS) relapse (isolated and combined with bone marrow relapse).

  1. Estimate the 1-year event-free survival (EFS) rate post CD19-CAR T cell therapy.

VI. Estimate 1-year overall survival (OS) post CD19-CAR T cell therapy. VII. Describe development of frailty after CD19-CAR T cell therapy.

EXPLORATORY OBJECTIVES:

  1. Measure expansion and persistence of CD19-CAR T cells in peripheral blood (PB), bone marrow (BM) and cerebrospinal fluid (CSF).

II. Assess the duration of B-cell aplasia. III. Describe cytokine levels in PB over the study period.

OUTLINE: This is a dose-escalation study of CD19-CAR T cell therapy followed by a dose-expansion study.

Patients undergo T cell leukapheresis, receive fludarabine and cyclophosphamide intravenously (IV), and then receive CD19-CAR T cell infusion IV on study.

Being tested
Autologous Anti-CD19 CAR-expressing T Lymphocytes, Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Cyclophosphamide, Fludarabine
Medical subject headings
Burkitt Lymphoma

What participants receive

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

  • Autologous Anti-CD19 CAR-expressing T LymphocytesDrug

    Also called Autologous Anti-CD19-CAR T Cells

    Given IV

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow Aspiration and BiopsyProcedure or surgery

    Undergo bone marrow aspirate

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • FludarabineDrug

    Also called Fluradosa

    Given IV

  • LeukapheresisProcedure or surgery

    Also called Leukocytopheresis, Therapeutic Leukopheresis

    Undergo T-cell leukapheresis

  • Questionnaire AdministrationOther

    Complete questionnaires

Study groups in NCT05707273
Study groupRoleWhat they receive
Treatment (CD19-CAR T cells)ExperimentalPatients undergo T cell leukapheresis, receive fludarabine and cyclophosphamide IV, and then receive CD19-CAR T cell infusion IV on study.
Receives: Drug: Autologous Anti-CD19 CAR-expressing T Lymphocytes; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cyclophosphamide; Drug: Fludarabine; Procedure: Leukapheresis; Other: Questionnaire Administration

What is being measured

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

  1. Incidence of dose-limiting toxicity (DLT)

    Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, and reversibility or outcome.

    Measured: Up to 28 days after CD19-chimeric antigen receptor (CAR) T cell infusion

  2. Incidence of adverse events

    Assessed using CTCAE version 5.0. Cytokine release syndrome adverse events will be characterized using the descriptions and grading scales found in the Lee, et. al. publication: 'ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, and reversibility or outcome.

    Measured: Up to 15 years

Secondary outcomes (6)

  1. Percentage of consented older B-acute lymphoblastic leukemia (ALL) patients undergoing leukapheresis who get sufficient CD19-CAR T cells manufactured and infused at their assigned dose level

    Feasibility will be assessed by the percentage of consented subjects undergoing leukapheresis who have sufficient CD19-CAR T cells manufactured and infused successfully. The rate and its 95% Clopper Pearson binomial confidence intervals (CIs) will be calculated. If it's 50% or higher, then the CD19-CAR T therapy is feasible to older B-ALL complete remission patients.

    Measured: At T cell infusion (Day 0)

  2. Minimal residual disease (MRD) response rate

    Defined as minimal residual disease level below 10^-4 by either polymerase chain reaction, next generation sequencing, or multicolor flow cytometry. Will be calculated with 95% Clopper Pearson binomial confidence intervals (CIs).

    Measured: Up to 12 months post T cell infusion

  3. Event-free survival

    Calculated by their 95% Clopper Pearson binomial CIs. Censored at the last follow-up if patients are known to be alive and free of event.

    Measured: From the start of CD19-CAR T cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years

  4. Overall survival rate

    Will be estimated using the product-limit method of Kaplan and Meier.

    Measured: From start of protocol therapy to death, or last follow-up, whichever comes first, assessed up to 15 years

  5. Rate of relapse, including MRD and extramedullary relapse

    MRD relapse defined as detectable of leukemic cells at > 0.01% in morphological remission bone marrow. Extramedullary relapse defined as documented ALL relapse outside the bone marrow. 95% Clopper Pearson binomial CIs will be calculated.

    Measured: Up to 2 years post treatment

  6. Frailty phenotype score

    Patients who score as frail at day 100 (3 or more of 5 points) or 1 point worsening for those with a baseline score of 3 or 4, they will be considered frail at day 100.

    Measured: Pre-CAR T and at day 100

Timeline

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

  1. First posted31 Jan 2023
  2. Study start26 Apr 2023
  3. Primary completion21 Sep 2027 (estimated)
  4. Study completion21 Sep 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05707273
Sponsor's protocol ID
22137
Other IDs
NCI-2022-10925, 22137, P30CA033572
Status last verified
Oct 2026
First submitted
20 Jan 2023
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Aldoss I, Goldberg L, Zhang J, Artz AS, Clark MC, Guan M, Espinosa R, Abimannan T, Wu J, Garcia B, Haas ER, Pathak KV, Lovell B, Pirrotte P, Agrawal V, Sanani N, Kasten S, Tilakawardane D, Wagner JR, Paul J, Shan H, Khaled S, Budde LE, Koller PB, Stein AS, Pullarkat VA, Salhotra A, Aribi A, Marcucci G, Wang X, Forman SJ. CAR T Cell Therapy as a Definitive Consolidation for Older Adults with B-ALL in First Complete Remission. Blood Adv. 2026 Jun 24:bloodadvances.2026020963. doi: 10.1182/bloodadvances.2026020963. Online ahead of print.

    PubMed 42341322

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Anti-CD19 CAR-expressing T Lymphocytes, Biospecimen Collection and Bone Marrow Aspiration and Biopsy in people with B Acute Lymphoblastic Leukemia, run by City of Hope Medical Center 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 29 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (DLT) (time frame: Up to 28 days after CD19-chimeric antigen receptor (CAR) T cell infusion). The study lists 2 primary outcomes in all. 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 NCT05707273, which also lists 1 linked publication.

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 8 Oct 2026.

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