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Diffuse Large B Cell LymphomaPhase 1NCT04176913

Study of LUCAR-20S in Patients With R/R NHL

A Phase 1 study testing LUCAR-20S CAR-T cells in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma, 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

An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
LUCAR-20S CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesChina
Study dates
1 Dec 2020to 9 Dec 2021
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 CD20+ non-Hodgkin's lymphoma (one of the following):
  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma (MCL)
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  • Small lymphocytic lymphoma (SLL)
  • Measurable disease as defined by 2014 Lugano criteria at Screening
  • Refractory/relapsed disease after standard-of- care treatment as following (Undergone at least 2 complete cycle of therapy for each line, unless PD been documented as the best response to the regimen) and not eligible or appropriate for HSCT (Auto/allo). Subject must have documented evidence of progressive disease on or within 12 months of their last regimen.
  • DLBCL: Refractory/relapsed after at least 1 prior line of therapy, must have been treated with anti-CD20 monoclonal antibody
  • FL: Refractory/relapsed after at least 2 prior lines of therapy, must have been treated with anti-CD20 monoclonal antibody
  • MCL: Refractory/relapsed after at least 2 prior lines of therapy
  • SLL: Refractory/relapsed after at least 2 prior lines of therapy
  • Laboratory criteria at Screening
  • ① Blood routine: NE≥1.0×109/L；HGB≥8g/dL；PLT≥50×109/L
  • ② Blood biochemical parameters:
  • Total bilirubin ≤ 1.5 times of the normal upper limit (ULN)
  • Aspartate and alanine aminotransferases (AST, ALT) ≤ 3 times ULN (in the presence of liver metastasis, ULN 5 times)
  • Estimated glomerular filtration rate (eGFR) > 60mL/min
  • Life expectancy > 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1

Who cannot join

  • Any malignancy besides the NHL 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
  • Prior treatment with an allogeneic stem cell transplant
  • Prior treatment with genetic therapy
  • Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at CD20 target
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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)
  • Prior antitumor therapy with insufficient washout period
  • Targeted therapy, epigenetic therapy, experimental drug therapy or experimental invasive treatment with medical apparatus and instruments 14 days or five half-lives, whichever is shorter before lymphodepletion
  • Use of monoclonal antibodies 21 days prior to lymphodepletion
  • Chemotherapy within 14 days prior to lymphodepletion
  • Radiotherapy within 14 days prior to lymphodepletion
  • Participated in other clinical trials within 30 days prior to lymphodepletion
  • With central nervous system involvement
  • Women in pregnancy or lactation
  • Being fertile and unable to use effective conception during treatment and 100 days after CAR-T infusion
  • Active autoimmune disease or history of autoimmune disease within 3 years
  • With obvious hemorrhagic tendency such as gastrointestinal hemorrhage, coagulation disorders and hypersplenism
  • The following cardiac conditions
  • New York Heart Association (NYHA) stage III or IV congestive heart failure
  • Left ventricular ejection fraction (LVEF) less than (<)45%
  • Uncontrolled cardiac arrhythmia post-medication
  • With a history of myocardial infraction or unstable angina pectoris within the past 6 months
  • Constrictive pericarditis
  • Cardiomyopathy
  • Pulse oximetry of <96% on room air
  • Active or uncontrolled infection requiring parenteral antibiotics, or any evidence of severe active viral/bacterial infection or uncontrolled systemic fungal infection
  • Uncontrolled diabetes mellitus, defined as fast serum glucose > 1.5 times ULN
  • Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease
  • Concurrent use of hematopoietic growth factor
  • Stroke or seizure within 6 months of signing ICF
  • Have received any live, attenuated vaccine within 4 weeks prior to lymphodepletion
  • Have underwent major surgical operation within 2 weeks prior to lymphodepletion, or anticipate to undergo a major surgical operation during the study process or within 2 weeks posterior to study treatment(with the exception of anticipated local anesthesia surgery)
  • Known life threatening allergies, hypersensitivity, or intolerance to LUCAR-20S CAR-T cells or its excipients, including dimethyl sulfoxide (DMSO)
  • 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

  • Hematological Department，Beijing Boren Hospital

    Beijing, 100070

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

    Hefei, Anhui, 230000

  • Hematological Department, People's Hospital of Jiangsu Province

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LUCAR-20S in Patients With Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma

An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.

Read the detailed description

This study is an open, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of donor-derived CD20-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD20 positive diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma or small lymphocytic lymphoma. The allo-CAR-T cells will be infused in single-dose.

Being tested
LUCAR-20S CAR-T cells
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • LUCAR-20S CAR-T cellsDrug

    An Anti-CD20 Allogeneic CAR-T Cell Therapy in Patients with Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma

Study groups in NCT04176913
Study groupRoleWhat they receive
Anti-CD20 Allogeneic CAR-T Cell TherapyExperimentalAn open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.
Receives: Drug: LUCAR-20S 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. Concentration of Pharmacokinetics in blood

    PK CAR positive T cells in peripheral blood, PK CAR transgene levels in peripheral blood

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

  4. Concentration of Pharmacokinetics in bone marrow

    PK CAR positive T cells in bone marrow, PK CAR transgene levels in bone marrow

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

Secondary outcomes (6)

  1. 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

  2. Overall response rate (ORR) after administration

    Antitumor efficacy by 2014 Lugano criteria

    Measured: 3 months post infusion

  3. Time to Response (TTR) after administration

    Antitumor efficacy by 2014 Lugano criteria

    Measured: 3 months post infusion

  4. Duration of remission (DOR) after administration

    Antitumor efficacy by 2014 Lugano criteria

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

  5. Progress Free Survival (PFS) after administration

    Antitumor efficacy by 2014 Lugano criteria

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

  6. Overall Survival (OS) after administration

    Antitumor efficacy by 2014 Lugano criteria

    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 posted25 Nov 2019
  2. Study start1 Dec 2020
  3. Primary completion9 Dec 2021
  4. Study completion9 Dec 2021

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04176913
Sponsor's protocol ID
BM2L201904
Other IDs
BM2L201904
Status last verified
Dec 2021
First submitted
18 Nov 2019
Last updated
10 Jan 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 LUCAR-20S CAR-T cells in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma, 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 21 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 10 Jan 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 NCT04176913.

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 10 Jan 2022.

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