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Non-hodgkin Lymphoma,B CellEarly Phase 1NCT06716164

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research

A Early Phase 1 study testing Metabolically Armed CD19 CAR-T cells in people with Non-hodgkin Lymphoma,B Cell, run by Zhejiang University at 1 site in China.

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

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

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Non-hodgkin Lymphoma,B Cell
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
1 Dec 2024to 5 Apr 2027
Phase
Early 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 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process;
  • Age > 18 years old, ≤ 70 years old, male or female;
  • Diagnosis of relapsed/refractory (R/R) indolent B-cell lymphoma, and/or R/R diffuse large B-cell lymphoma (DLBCL). Refractory diseases are defined as one of the following：
  • Patients with relapsed or refractory B-cell lymphoma treated with one standard treatment regimen and one salvage regimen treated with rituximab or another CD20 antibody drug and at least two treatment regiments appropriate for their disease, one of which should include anthracyclines;
  • After treatment with these regimens, patients maintain SD (SD duration ≤ 12 months) or still progress；
  • Recurrence after autologous hematopoietic stem cell transplantation, or recurrence of allogeneic HSCT, or inability to accept HSCT for various reasons；
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  • Patients with double-strike or triple-strike B-cell lymphoma who did not respond to second-line therapy；
  • CD19 expression was positive by immunohistochemistry or flow cytometry (accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection);
  • If the subject has progressed or relapsed after prior CD19 CAR-T cell therapy, the planned apheresis phase should be at least 1 month after that, or the subject has been treated with other biologics, but is in the washout period;
  • At least one measurable lesion at baseline, according to the Preliminary Assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition);
  • Expected survival time greater than 12 weeks;
  • ECOG score 0-1 (subjects with central nervous system diseases caused by leukemia or lymphoma need to be determined by the investigator);
  • Organ function：
  • Complete blood count (CBC) test [the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection]
  • Lymphocyte count ≥ 0.5×109/L (except for those receiving bridging chemotherapy);
  • Platelet count ≥ 25×109/L;
  • Hemoglobin ≥ 70.0 g/L
  • Blood Biochemistry:
  • Serum creatinine (Scr) ≤ 1.5 x ULN, or
  • endogenous creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault formula);
  • alanine aminotransferase (ALT) ≤ 2.5 x ULN;
  • aspartate aminotransferase (AST) ≤ 2.5 ×ULN;
  • Total bilirubin (TBIL) ≤ 2 ×ULN; Subjects with total bilirubin < 3 × ULN and direct bilirubin < 1.5× ULN with Gilbert-.Meulengracht syndrome could be included;
  • Serum lipase and amylase ≤ 1.5×ULN;
  • Alkaline phosphatase (ALP) ≤ 2.5 ×ULN;
  • In case of bone or liver metastasis, AST, ALT and ALP ≤ 5 ×ULN;
  • Prothrombin time (PT) extended ≤ 4 s, fibrinogen ≥ 1 g/L, activated partial thromboplastin time (APTT) ≤ 1.5 ×ULN;
  • 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;
  • Stop all anti-proliferation therapies other than preconditioning chemotherapy in the 2 weeks before 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 not associated with leukemia or lymphoma， 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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  • History of unstable angina and/or myocardial infarction within 6 months prior to signing the informed consent; History of uncontrolled thrombotic events, major bleeding, or deep venous thrombosis (DVT) within 12 months prior to signing the informed consent;
  • 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);
  • History of QT interval prolongation or severe cardiac disease;
  • Before signing the informed consent form, the ADA (FMC63) test was significantly positive (the test result was weakly positive, and it was necessary to discuss with the investigator whether to rule it out);
  • Other conditions that the investigator considered should not be enrolled in this clinical study.

Trial locations and contacts

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

Mingming Zhang contact

86-13656674208

mingmingzhang@zju.edu.cn

China1 site, 1 recruiting

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang, 310000

    He Huang, MD, 86-13605714822, hehuangyu@126.com

    Yongxian Hu, MD, 86-15957162012, huyongxian2000@aliyun.com

    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 B-cell Non-Hodgkin lymphoma

Read the detailed description

This is a single arm,open-label study.This study is indicated for relapsed and/or refractory B-cell Non-Hodgkin lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products and our earlier disclosed clinical trials.

  1. Main research objectives: To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r B-NHL.
  2. Secondary research objectives:
  • To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion.
  • 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, B-cell Non-hodgkin Lymphoma
Medical subject headings
Lymphoma, B-Cell

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 NCT06716164
Study groupRoleWhat they receive
Administration of Metabolically Armed CD19 CAR-T cellsExperimentalPatients or donors 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 35 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 posted4 Dec 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion5 Apr 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
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
NCT06716164
Sponsor's protocol ID
Meta10-19-006
Status last verified
Nov 2024
First submitted
29 Nov 2024
Last updated
4 Dec 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 Non-hodgkin Lymphoma,B Cell, run by Zhejiang University 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 36 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: looking for participants now, as of the sponsor's last update on 4 Dec 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?

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 Mingming Zhang (86-13656674208, mingmingzhang@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 35 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 NCT06716164.

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 4 Dec 2024.

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