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Acute Lymphoblastic LeukemiaEarly Phase 1NCT06393335

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research

A Early Phase 1 study testing Metabolically Armed CD19 CAR-T cells in people with Acute Lymphoblastic Leukemia and Non-hodgkin Lymphoma, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies Read more about this study

Who is it for?
Ages 6 months to 18 years
What is being tested?
Metabolically Armed CD19 CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
15 May 2024to 15 Mar 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

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 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age range: 6 months to 18 years old, inclusive, for both males and females.
  • The patient or their guardian voluntarily signed the informed consent.
  • Patients with relapsed or refractory CD19-positive B cell hematological malignancies:
  • Relapsed or refractory B-ALL (meeting one of the following conditions):
  • Patients who relapse within 30 months after the initial remission, with >5% primordial cells (lymphoblast and prolymphocyte) in bone marrow morphology, confirmed by flow cytometry.
  • Patients who relapse 30 months after the initial remission and fail to achieve complete remission or show poor response to early treatment after one course of standardized induction therapy.
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  • Patients who relapse after allogeneic hematopoietic stem cell transplantation (HSCT) and must undergo screening 3 months post-HSCT .
  • Patients who do not achieve CR after standardized chemotherapy, or have >1% minimal residual disease (MRD) in bone marrow after 3 months of chemotherapy.
  • Philadelphia-chromosome-positive (Ph+) patients who do not achieve CR or relapse after being treated with at least two tyrosine kinase inhibitors (TKI).
  • Patients who are not suitable candidates for allogeneic hematopoietic stem cell transplantation.
  • Relapsed or refractory CD19+ B-NHL (meeting one of the following conditions):
  • Patients who have been treated with CD20 antibodies (such as rituximab) and at least two chemotherapy regiments, one of which should include anthracyclines.
  • After these treatments, patients experienced stable disease (SD) (with SD duration ≤12 months) or disease progression.
  • Patients who relapse after auto/allo-HSCT, or are not eligible for HSCT.
  • Patients with double-hit and triple-hit lymphoma who do not respond to second-line treatment.
  • Positive CD19 expression comfirmed by immunohistochemistry or flow cytometry.
  • For participants who had failed prior CD19-CAR T cell therapy: at least 30-days has elapsed since participant received last CD19-CAR T cell therapy.
  • Presence at least one measurable lesion at baseline, as per the initial assessment, staging and response assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition).
  • Life expectancy ≥ 12 weeks.
  • ECOG ≤ 1.
  • Organ function:
  • Complete blood count (CBC) test results should meet the following criteria within 24 hours before apheresis (Avoid blood/platelet transfusion, cell growth factors (except recombinant erythropoietin) and other supportive treatments within 7 days prior to the test):
  • Absolute Lymphocyte Count (ALC) ≥ 0.5×10^9 /L (except for those receiving bridging chemotherapy).
  • Platelet (PLT) ≥ 25×10^9 /L.
  • Hemoglobin (Hb) ≥ 70.0 g/L
  • Blood biochemistry:
  • Serum creatinine (Scr) ≤ 1.5× Upper limit of normal (ULN), or Creatinine Clearance (Ccr) ≥ 40 mL/min (calculated using the Cockcroft-Gault formula).
  • Alanine aminotransferase (ALT) ≤ 2.5×ULN.
  • Aspartate aminotransferase (AST) ≤ 2.5×ULN.
  • Total bilirubin (TBIL) ≤ 2×ULN; Patients who with Gilbert-Meulengracht syndrome with TBIL ≤ 3×ULN and Direct Bilirubin (DBIL) ≤1.5×ULN may be included.
  • Amylase (AMY) and Lipase (LPS) ≤ 1.5×ULN.
  • Alkaline phosphatase (ALP) ≤ 2.5×ULN.
  • If bone or liver metastases are present, AST, ALT, ALP ≤ 5×ULN.
  • Prothrombin time (PT) was extended ≤ 4 s, fibrinogen ≥ 1 g/L, activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
  • Pulmonary function: dyspnea ≤ CTCAE grade 1 and blood oxygen saturation (SaO2) ≥ 91% in ambient air.
  • Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) with a left ventricular ejection fraction (LVEF) ≥ 45％.
  • Patients taking the following medications must meet the following criteria:
  • Steroids: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, with hydrocortisone or its equivalent < 6-12mg/mm^2/day.
  • Immunosuppressive agents: Any immunosuppressive medication must be stopped ≥ 4 weeks before signing the informed consent.
  • Anti-proliferative therapy other than preconditioning chemotherapy should be ceased within 2 weeks prior to Meta10-19 infusion.
  • Treatment for central nervous system (CNS) diseases must be stopped 1 week before Meta10-19 infusion (e.g., intrathecal methotrexate).
  • As determined by the researchers, patients who have recovered from the toxicity of the previous treatments, that is, the CTCAE toxicity grade is less than 1 (excluding specific toxicity of grade 2 or lower, such as hair loss, deemed irrecoverable in a short timeframe by the researchers) are suitable for receiving pretreatment chemotherapy and CAR-T cell therapy.
  • The patient should have adequate venous access for apheresis or peripheral blood collection, with no other contraindications for blood cell separation.

Who cannot join

  • Patients with a history of central nervous system (CNS) diseases other than CNS leukemia, such as seizures disorders, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
  • Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion.
  • Patients who have participated in other clinical trials within 30 days prior to enrollment.
  • Patients with active hepatitis B (defined as positive for hepatitis B surface antigen or hepatitis B core antibody, with concomitant hepatitis B virus DNA level > 1000 copies/ml) or hepatitis C (positive for HCV RNA).
  • Patients who are positive for HIV antibodies or treponema pallidum antibodies.
  • Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g., positive blood cultures ≤ 72 hours before Meta10-19 infusion).
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  • Patients with unstable angina pectoris and/or myocardial infarction within 6 months prior to enrollment..
  • Patients with history of other malignancies may be eligible for enrollment under the following conditions:
  • Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent).
  • Carcinoma in situ (DCIS) of cervical or breast cancer, which has been treated therapeutically, has shown no signs of recurrence for at least 3 years prior to the signing of the informed consent.
  • The primary malignancy has been completely resected and in complete remission for ≥ 5 years.
  • Patients with active neuroautoimmune or inflammatory conditions (e.g., Guillian-Barre syndrome, amyotrophic lateral sclerosis).
  • Patients with other conditions deemed unsuitable for enrollment in this clinical study by the investigator.

Trial locations and contacts

1 site in 1 country.

Xiaojun Xu, PhD contact

86- 13858067554

xuxiaojun@zju.edu.cn

China1 site, 1 recruiting

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Xiaojun Xu, PhD, 86- 13858067554, xuxiaojun@zju.edu.cn

    Xiaojun Xu, PhD

    Recruiting

Other trials in China

About this study

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies

Read the detailed description

This is a single arm, open-label study. This study is indicated for relapsed or refractory CD19-positive B cell Hematological Malignancies.

  1. Main research objectives: To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r CD19-positive B cell Hematological Malignancies
  2. Secondary research objectives:
  3. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion.
  4. To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.
Being tested
Metabolically Armed CD19 CAR-T cells
Keywords
Meta10-19, CAR-T Cells Therapy, CD19-positive B cell Hematological Malignancies
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

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

  • Metabolically Armed CD19 CAR-T cellsDrug

    Also called Meta10-19

    Each subject receive metabolically armed CD19 CAR- T cells by intravenous infusion.

Study groups in NCT06393335
Study groupRoleWhat they receive
Administration of Metabolically Armed CD19 CAR-T cellsExperimentalPatients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion. A dose of metabolically armed CD19 CAR-T cells will be infused on day 0.
Receives: Drug: Metabolically Armed CD19 CAR-T cells

What is being measured

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

  1. MTD

    Determine the Maximal Tolerable Dose(MTD)

    Measured: MTD will be determined based on DLTs observed during the first 28 days of study treatment

  2. Objective response rate (ORR)

    Measure Tumor response rate (including CR and PR)

    Measured: Within 3 months following infusion of Meta10-19

Secondary outcomes (2)

  1. Concentration of CAR-T cells

    Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion

    Measured: Up to 12 months after CAR-T treatment

  2. Pharmacodynamics of CAR-T cells

    Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, INF-γ at each time point

    Measured: Up to 28 days after infusion

Timeline

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

  1. First posted1 May 2024
  2. Study start15 May 2024 (estimated)
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion15 Mar 2026 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06393335
Sponsor's protocol ID
Meta10-19-005
Status last verified
Apr 2024
First submitted
28 Apr 2024
Last updated
1 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Metabolically Armed CD19 CAR-T cells in people with Acute Lymphoblastic Leukemia and Non-hodgkin Lymphoma, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.

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 43 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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 China. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Xiaojun Xu, PhD (86- 13858067554, xuxiaojun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: MTD will be determined based on DLTs observed during the first 28 days of study treatment). 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 NCT06393335.

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 1 May 2024.

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