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Relapsed and Refractory B Cell LymphomaEarly Phase 1NCT04169932

The Clinical Study of CD20 CAR-T Cells in Patients With Relapsed and Refractory B Cell Non-Hodgkin Lymphoma

A Early Phase 1 study testing CD20 CAR-T in people with Relapsed and Refractory B Cell Lymphoma and Non-Hodgkin Lymphoma, run by Shanghai Longyao Biotechnology Inc., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single arm, open-label study to evaluate the safety, tolerance and efficacy of CD20 CAR-T Cells in patients with relapsed and refractory B cell non-Hodgkin Lymphoma. Subjects receive a single intravenous infusion of CD20-CART cells per treatment course. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CD20 CAR-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
22 Nov 2019to 22 Nov 2022
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients with CD20+ relapsed or refractory B cell Non-Hodgkin lymphoma, which includes but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, transformed follicular lymphoma, marginal-zone lymphoma, mantle-cell lymphoma, small B-cell lymphoma, are eligible for inclusion in this study must meet one of the following criteria:
  • Relapsed or refractory as defined by not achieving a PR after a second-line drug therapy such as CD20 monoclonal antibodies, or achieving a PR but the disease has progressed, or chieving a CR but the disease has relapsed.
  • Relapse after autologous stem cell transplantation (SCT) within 1 year.
  • 2. Adult subjects between 18 and 70 years of age, inclusive.
  • 3. Life expectancy > 3 months.
  • 4. ECOG score between 0 and 1.
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  • 5. Liver, Renal, Heart and Lungs function defined as:
  • Creatininec≤1.5 ULN;
  • ALT/AST ≤2.5 ULN;
  • Total Bilirubin≤1.5×ULN;
  • Pulse oxygenation≥92%;
  • Left Ventricular Shortening Fraction (LVSF)≥50%;
  • Echocardiogram (ECHO) shows no obvious pericardial effusion.
  • 6. According to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma, the lesions must meet the minimum size requirement of being >15 mm in longest diameter (LDi).
  • 7. Subjects could comprehend the clinical study and able to provide written consent at the time of consent or assent.

Who cannot join

  • 1. Pregnant or lactating women, or women with pregnancy plans within 6 months.
  • 2. HBsAg or the titer of HBV was not in the range of normal reference value; positive for presence of HCV antibody or HCV RNA in peripheral blood; positive for presence of human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2).
  • 3. Severe heart disease: include but not limited to Unstable angina pectoris, myocardial infarction (within 6 months before screening), Congestive heart failure (New York Heart Association [NYHA] Classification ≥ III).
  • 4. Previously received other CART therapy or transgenic cell therapy.
  • 5. The subjects participated in clinical trials within 6 months before screening.
  • 6. Subjects who were receiving systemic steroid therapy and determined by the researchers to require long-term use of systemic steroid therapy except for inhalation or local use before screening.
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  • 7. Subjects who had more than 2 years of autoimmune disease history (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that caused organ damage or subjects who needed to take systemic immunosuppressants;
  • 8. Any unstable systemic disease, including but not limited to, liver, kidney or metabolic diseases requiring drug treatment.
  • 9. Autologous transplantation or allotransplantation was performed within 6 months after admission.
  • 10. Evidence or history of central nervous system involvement in lymphoma.
  • 11. Subjects with active bleeding caused by the involvement of the original lesion in the digestive tract.
  • 12. Subjects with active infectious diseases who received systematic antibiotic treatment within 2 weeks of admission.
  • 13. Other subjects judged by the researchers to be unsuitable for admission to the study.

Trial locations and contacts

1 site in 1 country.

Tengfeng Ni, Master contact

+86 021- 66289710

nitengfeng@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Jianyong Li

    Jianyong Li

    Recruiting

Other trials in China

About this study

This is a single arm, open-label study to evaluate the safety, tolerance and efficacy of CD20 CAR-T Cells in patients with relapsed and refractory B cell non-Hodgkin Lymphoma. Subjects receive a single intravenous infusion of CD20-CART cells per treatment course.

Read the detailed description

The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 ^ 6 cells/kg,2 × 10 ^ 6 cells/kg,4 × 10 ^ 6 cells/kg,8 × 10 ^ 6 cells/kg). Each CD20-CART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers. The observation period was 4 weeks after the end of the course of treatment. If 2 or more cases of DLT occurred at a certain dose level, the prior dose level was the maximum tolerable dose of (MTD). If one case of DLT occurred, 3 subjects were added to the group. If there were no DLT in 3 cases, the next dose level would be estimated. If at least 1 case of DLT occurred in the 3 cases, the prior dose was the maximum tolerated dose of (MTD). If there were no DLT at the maximum dose, the maximum tolerant dose was the maximum dose.

Being tested
CD20 CAR-T
Keywords
CD20 CAR T Cells, Safety, tolerance and efficacy
Medical subject headings
Recurrence, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • CD20 CAR-TBiological

    The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 ^ 6 cells/kg,2 × 10 ^ 6 cells/kg,4 × 10 ^ 6 cells/kg,8 × 10 ^ 6 cells/kg).

Study groups in NCT04169932
Study groupRoleWhat they receive
CD20 CAR-TExperimentalNot described
Receives: Biological: CD20 CAR-T

What is being measured

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

  1. The Adverse events (AEs)

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Measured: 4 weeks

  2. Expression of CD20 CART cells

    Expression of CD20 CART cells detected by flow cytometry in blood and bone marrow

    Measured: 2 years

  3. Detection of CD20 CART cells

    Detection of CD20 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).

    Measured: 2 years

  4. Graft Activity Endpoint Detection

    The vector copy number (VCN) of the exogenous CAR vector in the blood and bone marrow.

    Measured: 2 years

Secondary outcomes (6)

  1. Overall remission rate (ORR)

    Measured: 2 years

  2. Complete Remission (CR)

    Measured: 2 years

  3. Partial Remission (PR)

    Measured: 2 years

  4. To evaluate the duration of remission (DOR)

    Measured: 2 years

  5. To evaluate the Progression-free survival (PFS)

    Measured: 2 years

  6. To evaluate the Overall survival (OS)

    Measured: 2 years

Timeline

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

  1. First posted20 Nov 2019
  2. Study start22 Nov 2019 (estimated)
  3. Primary completion22 Nov 2022 (estimated)
  4. Study completion22 Nov 2022 (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
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04169932
Sponsor's protocol ID
20191023V1.1
Status last verified
Nov 2019
First submitted
8 Nov 2019
Last updated
20 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD20 CAR-T in people with Relapsed and Refractory B Cell Lymphoma and Non-Hodgkin Lymphoma, run by Shanghai Longyao Biotechnology Inc., Ltd. 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 15 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 20 Nov 2019. 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 Tengfeng Ni, Master (+86 021- 66289710, nitengfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Adverse events (AEs) (time frame: 4 weeks). 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 NCT04169932.

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 20 Nov 2019.

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