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Acute Lymphoblastic LeukemiaEarly Phase 1NCT06277011

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 Anhui Provincial Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 3 to 70 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
18 participants
Where
1 siteChina
Study dates
10 Feb 2023to 15 May 2025
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 3 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The patient or his/her guardian voluntarily signed the informed consent.
  • Meeting one of the following conditions:
  • Patients with relapsed or refractory B-cell lymphoma who have received CD20 antibodies (such as rituximab) and at least two chemotherapy treatments, one of which should include anthracyclines. After these regimens, patients maintained SD (SD duration ≤12 months) or disease progression.
  • Partial remission (PR) or minimal residual lesions after two chemotherapy treatments.
  • Recurrence after autologous hematopoietic stem cell transplantation.
  • Extramedullary recurrence or residual leukemia cells ≥ 0.01% in bone marrow after allogeneic hematopoietic stem cell transplantation.
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  • Patients with relapsed or refractory B-ALL who not suitable for hematopoietic stem cell transplantation.
  • CD19 expression was positive by immunohistochemistry or flow cytometry (>30%)，accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection.
  • At least one measurable lesion at baseline, according to the initial assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition).
  • Expected survival time greater than 12 weeks.
  • The baseline ECOG score was 0 or 1.
  • Patients with proper organ function:
  • Kidney function is defined as:
  • Serum creatinine ≤1.5 times ULN, or; The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m/ min/1.73m2.
  • Liver function is defined as: ALT≤5 times ULN, and; Patients with total bilirubin ≤2.0mg/dl, except those with Gilbert-Meulengracht syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN were included.
  • Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.
  • Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45.
  • Patients using the following drugs must meet the following conditions:
  • Steroid: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, hydrocortisone or its equivalent < 6- 12mg/mm2/ day.
  • Immunosuppressive agent: Any immunosuppressive drug must be stopped ≥4 weeks before the informed consent is signed.
  • Anti-proliferative therapy in addition to preconditioning chemotherapy 2 weeks prior to Meta10- 19 infusion.
  • Treatment for CNS disease must be stopped 1 week before Meta10-19 infusion (e.g., intrathecal methotrexate)
  • The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than 1 (The exception is specific toxicity of grade 2 or less, such as hair loss, which the researchers have determined is not recoverable in a short period of time) is suitable for pretreatment chemotherapy and CAR-T cell therapy.
  • Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR-T cells in vivo.

Who cannot join

  • Patients with present or history of central nervous system diseases such as seizures disorder, 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 participated in other clinical trials within 30 days prior to enrollment.
  • Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level >1000 copies/ml) or hepatitis C (HCV RNA positive).
  • Patients with HIV antibody positive or treponema pallidum antibody positive.
  • 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, but the following conditions can be enrollment:
  • 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.
  • Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive).
  • Patients with active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis).
  • Other conditions that the investigator considered should not be enrolled in this clinical study.
  • B-ALL patients meeting one of the following conditions:
  • Isolated extramedullary recurrence.
  • Central nervous system leukemia was treated within 1 week prior to CAR T cell infusion.

Trial locations and contacts

1 site in 1 country.

Xingbing Wang, PhD contact

+8613856007984

wangxingbing@ustc.edu.cn

China1 site, 1 recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 518000

    Xingbing Wang, PhD, +8613856007984, wangxingbing@ustc.edu.cn

    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. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products.

  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, r/r 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 NCT06277011
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 posted26 Feb 2024
  2. Study start10 Feb 2023
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion15 May 2025 (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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277011
Sponsor's protocol ID
Meta10-19-004
Status last verified
Feb 2024
First submitted
18 Feb 2024
Last updated
26 Feb 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 Anhui Provincial Hospital 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 24 inclusion and 17 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 26 Feb 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 Xingbing Wang, PhD (+8613856007984, wangxingbing@ustc.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 NCT06277011.

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 26 Feb 2024.

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