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CD4+ T Lymphocyte Tumor (T Cell Lymphoma and T Cell Leukemia)Phase 1NCT04219319

LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma

A Phase 1 study testing Efficacy of LCAR-T2C CAR-T cells in people with CD4+ T Lymphocyte Tumor (T Cell Lymphoma and T Cell Leukemia), run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Phase I, Multicenter study to evaluate the safety, tolerability, and Efficacy of LCAR-T2C CAR-T cells in relapsed or refractory CD4+T Lymphocyte Tumor Patients. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Efficacy of LCAR-T2C CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
3 sitesChina
Study dates
15 Dec 2021to 20 Jul 2022
Phase
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form (ICF)
  • Age 18 Years to 75 Years
  • Pathological diagnosis of refractory/relapsed CD4+ T lymphocyte tumor (one of the following):
  • T-cell Non-Hodgkin lymphoma(T-NHL)：The best response is progressive disease(PD) or stable disease(SD) after at least 1 prior line of therapy（at least 2 complete cycle of therapy）
  • T-cell Acute lymphoblastic leukemia(T-ALL)：The best response is not complete response(CR) after induction therapy
  • Measurable disease is necessary at Screening
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  • Life expectancy ≥ 3 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 -2.
  • The screening phase clinical laboratory values meet the following criteria. Laboratory test(s) may be repeated once, to determine if the subject qualifies for study participation :
  • Blood routine:
  • HGB≥6g/dL；PLT≥20×10^9/L; ANC≥1.0×10^9/L; LY≥0.3×10^9/L
  • Blood biochemical parameters:
  • Aspartate and alanine aminotransferases (AST, ALT) ≤ 2.5 times ULN (in the presence of liver metastasis, AST and ALT≤5 times ULN)
  • Serum creatinine (Scr) ≤ 1.5 times ULN, estimated glomerular filtration rate (eGFR) > 60mL/min (only when Scr>1.5 times ULN)
  • Total bilirubin ≤ 1.5 times of the normal upper limit (ULN)
  • International Normalized Ratio (INR) ≤ 1.5 times ULN, PT≤ 1.5 times ULN, APTT≤ 1.5 times ULN

Who cannot join

  • Prior treatment with CAR-T therapy directed at any target.
  • Any therapy that is targeted to CD4.
  • Prior treatment with an allogeneic stem cell transplant
  • Any malignancy besides the T lymphocyte tumor categories under study, exceptions include
  • Any other malignancy curatively treated and disease-free for at least 2 years prior to enrollment
  • History of non-melanoma skin cancer with sufficient treatment and currently no evidence of recurrence
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  • Those who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab)
  • The following cardiac conditions:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure
  • Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment
  • History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
  • History of severe non-ischemic cardiomyopathy
  • Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed ≤8 weeks of apheresis)
  • Prior antitumor therapy as follows, prior to apheresis:
  • Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less.
  • Monoclonal antibody treatment for multiple myeloma within 21 days.
  • Cytotoxic therapy within 14 days.
  • Radiotherapy within 14 days.
  • Participated in other clinical trials within 30 days.
  • Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
  • With central nervous system involvement.
  • Serious underlying medical condition, such as:
  • Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection
  • Active or unstable autoimmune diseases or autoimmune diseases that have been suffered within 3 years and have the possibility of recurrence
  • Overt clinical evidence of dementia or altered mental status
  • Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 100 days after receiving study treatment.
  • Plans to father a child while enrolled in this study or within 100 days after receiving study treatment.
  • With obvious hemorrhagic tendency such as gastrointestinal hemorrhage, coagulation disorders and hypersplenism
  • Oxygen is needed to maintain sufficient blood oxygen saturation(≥95%)
  • Suffer from chronic diseases that require treatment with systemic corticosteroids or other immunosuppressive agents ,Received a cumulative dose of corticosteroids equivalent to ≥20 mg/day of prednisone within 7 days prior to apheresis
  • CNS diseases with clinical significance in the past or at the time of screening
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis
  • Major surgery within 2 weeks prior to apheresis, or has surgery planned during the study or within 2 weeks after study treatment administration. (Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.)
  • Known life threatening allergies, hypersensitivity, or intolerance to LCAR-T2C CAR-T cells or its excipients, including DMSO (refer to Investigator's Brochure)
  • Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Oncology Department，The First Affiliated Hospital of USTC west district

    Hefei, Anhui, 230000

  • Hematological Department, People's Hospital of Jiangsu Province

    Nanjing, Jiangsu, 210029

  • Hematological Department，The First Affiliated Hospital of the Air Force Medical University

    Xi’an, Shanxi, 710032

Other trials in China

About this study

Official title: A Phase I, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor Patiens

A Phase I, Multicenter study to evaluate the safety, tolerability, and Efficacy of LCAR-T2C CAR-T cells in relapsed or refractory CD4+T Lymphocyte Tumor Patients.

Read the detailed description

This is an open, dose escalation/dose extension study of LCAR-T2C CAR-T cells administrered to patients with T lymphocyte tumor. The aim of the study is to evaluate the safety, tolerability, and efficacy of LCAR-T2C CAR-T cells. The auto-CAR-T cells will be infused in single-dose.

Being tested
Efficacy of LCAR-T2C CAR-T cells
Medical subject headings
Lymphoma, T-Cell, Leukemia, T-Cell

What participants receive

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

  • Efficacy of LCAR-T2C CAR-T cellsDrug

    CD4-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD4 positive T lymphocyte tumor

Study groups in NCT04219319
Study groupRoleWhat they receive
Experimental: LCAR-T2C CAR-T cells in relapsed or refractory CD4+ T lymphocyte tumorExperimentalAn open label, multi center, single arm Phase I study to evaluate the safety, tolerability, and efficacy of LCAR-T2C CAR-T cells in relapsed or refractory CD4+ T lymphocyte tumor.
Receives: Drug: Efficacy of LCAR-T2C CAR-T cells

What is being measured

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

  1. Dose limiting toxicity (DLT)

    DLT assessed by NCI-CTCAE 5.0

    Measured: 30 days post infusion

  2. Adverse events

    Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

    Measured: 90 days post infusion

  3. Recommended Phase II dose (RP2D)

    RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion

    Measured: 30 days post infusion

  4. Pharmacokinetics

    PK CAR positive T cells in peripheral blood, PK CAR transgene levels in peripheral blood, PK CAR positive T cells in bone marrow and PK CAR transgene levels in bone marrow.

    Measured: through study completion, 2 years after infusion of the last subject

Secondary outcomes (6)

  1. Anti-drug antibody

    Anti-drug antibody (ADA) will be conducted on blood sample for immune response analyses.

    Measured: through study completion, 2 years after infusion of the last subject

  2. Overall response rate (ORR) after administration

    Measured: through study completion, 2 years after infusion of the last subject

  3. Time to Response (TTR) after administration

    Measured: through study completion, 2 years after infusion of the last subject

  4. Duration of remission (DOR) after administration

    Measured: through study completion, 2 years after infusion of the last subject

  5. Progress Free Survival (PFS) after administration

    Measured: through study completion, 2 years after infusion of the last subject

  6. Over Survival (OS) after administration

    Measured: through study completion, 2 years after infusion of the last subject

Timeline

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

  1. First posted7 Jan 2020
  2. Study start15 Dec 2021
  3. Primary completion20 Jul 2022
  4. Study completion20 Jul 2022

Why it stopped: Both the sponsors and collaborator are considering terminating the study

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04219319
Sponsor's protocol ID
BM2L201905
Status last verified
Aug 2022
First submitted
20 Nov 2019
Last updated
16 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Efficacy of LCAR-T2C CAR-T cells in people with CD4+ T Lymphocyte Tumor (T Cell Lymphoma and T Cell Leukemia), run by The First Affiliated Hospital with Nanjing Medical University at 3 sites 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 16 inclusion and 35 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: stopped early, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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?

The study was stopped early (reason given: Both the sponsors and collaborator are considering terminating the study). Results are not available in the source record.

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?

Dose limiting toxicity (DLT) (time frame: 30 days post infusion). The study lists 4 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 NCT04219319.

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 16 Aug 2022.

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