AzTrials
AzTrials

Diffuse Large B-cell LymphomaPhase 1CICPDNCT04381741

CD19 CAR-T Expressing IL7 and CCL19 Combined With PD1 mAb for Relapsed or Refractory Diffuse Large B Cell Lymphoma

A Phase 1 study testing CD19-7×19 CAR-T plus PD1 monoclonal antibody in people with Diffuse Large B-cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

Diffuse large B-cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for 35% of lymphoma. Chimeric antigen receptor T cell (CAR-T) therapy is a new method to treat DLBCL. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
CD19-7×19 CAR-T plus PD1 monoclonal antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
18 Jun 2020to 1 Sep 2023
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

  • (1) Age ≥ 18, upper limit 75, unlimited for men and women;
  • ECOG score 0-3;
  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL) [according to who 2008];
  • CD19 was positive (immunohistochemistry or flow cytometry).
  • The definition of refractory or relapse of DLBCL is: no complete remission after 2-line treatment; disease progression in any treatment process, or disease stabilization time equal to or less than 6 months; or disease progression or relapse within 12 months after hematopoietic stem cell transplantation;
  • The previous treatment of diffuse large B cell lymphoma must include rituximab (CD20 mAb) and anthracycline;
Show all 13Show fewer
  • There should be at least one measurable focus. It is required that any length of lymph node focus should be greater than 1.5cm or any length of extranodal focus should be greater than 1.0cm. PET-CT scan focuses should have uptake (SUV is greater than liver blood pool);
  • The absolute value of neutrophils in peripheral blood ≥ 1000 / μ L, platelet ≥ 45000 / μ L;
  • Heart, liver and kidney function: creatinine < 1.5mg/dl; ALT (alanine aminotransferase) / AST (aspartate aminotransferase) 2.5 times lower than the normal upper limit; total bilirubin < 1.5mg/dl; heart ejection fraction (EF) ≥ 50%;
  • Sufficient understanding ability and voluntary signing of informed consent;
  • Those with fertility must be willing to use contraceptive methods;
  • According to the judgment of the researchers, the expected survival time is more than 4 months;
  • Willing to follow visit schedule, administration plan, laboratory inspection and other test steps.

Who cannot join

  • (1) History of other tumors;
  • Hematopoietic stem cell transplantation was performed within 6 weeks;
  • Any target car-t treatment was performed within 3 months before the car-t treatment;
  • Previous use of any commercially available PD-1 mAb;
  • Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection;
  • Active autoimmune diseases;
Show all 9Show fewer
  • Uncontrollable infection of active bacteria and fungi;
  • HIV infection, syphilis infection; active hepatitis B or C: hepatitis B: HBV-DNA ≥ 1000IU / ml; hepatitis C: HCV RNA positive and liver function abnormal.
  • Known central nervous system lymphoma.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Diffuse large B-cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for 35% of lymphoma. Chimeric antigen receptor T cell (CAR-T) therapy is a new method to treat DLBCL. KTE-C19, published in the New England Medical Journal in December 2017, was used to treat relapsed and refractory B-cell lymphoma. One year of treatment for 111 patients, the total response rate was 82%, and the complete remission rate was 54%. However, a large number of clinical studies have shown that about 20% of patients with B-ALL and 50% of patients with B-NHL cannot achieve complete remission (CR) after CD19-CAR-T treatment. Targeting tumor microenvironment is an important new method to overcome the drug resistance of CAR-T cells. In this study, IL-7 and CCL19 were connected on the basis of traditional second generation CD19 CAR-T cells to construct novel fourth generation CAR-T cells, which can promote the infiltration, accumulation and survival of CAR-T cells in lymphoma tissue, and further enhance the anti-tumor effect of traditional CAR-T cells. At the same time, combined with four generations of CAR-T cells and PD1 monoclonal antibody, PD1 / PDL1 signal pathway was blocked, anti-tumor effect of CAR-T was improved, and immune response and long-term remission rate of DLBCL were improved.

Being tested
CD19-7×19 CAR-T plus PD1 monoclonal antibody
Keywords
diffuse large B-cell lymphoma, Chimeric antigen receptor T cell, PD1 monoclonal antibody
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • CD19-7×19 CAR-T plus PD1 monoclonal antibodyBiological

    Three different doses of CD19-7×19 CAR-T (1×106/kg、2×106/kg、3×106/kg) plus 200mg Tislelizumab every 3 weeks for 6 times

Study groups in NCT04381741
Study groupRoleWhat they receive
CD19-7×19 CAR-T plus PD1 monoclonal antibodyExperimentalNot described
Receives: Biological: CD19-7×19 CAR-T plus PD1 monoclonal antibody

What is being measured

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

  1. Objective response rate

    Objective response rate of the combination of CD19 CAR-T Expressing IL7 and CCL19 and PD1 mAb

    Measured: 3 months

Secondary outcomes (4)

  1. progression-free survival

    progression-free survival of the combination of CD19 CAR-T Expressing IL7 and CCL19 and PD1 mAb

    Measured: 2 years

  2. overall survival

    overall survival of the combination of CD19 CAR-T Expressing IL7 and CCL19 and PD1 mAb

    Measured: 2 years

  3. Duration of Overall Response

    Duration of Overall Response of the combination of CD19 CAR-T Expressing IL7 and CCL19 and PD1 mAb

    Measured: 2 years

  4. Relapse rate

    Relapse rate of the combination of CD19 CAR-T Expressing IL7 and CCL19 and PD1 mAb

    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 posted11 May 2020
  2. Study start18 Jun 2020
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Sep 2023 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381741
Sponsor's protocol ID
IR2020001132
Acronym
CICPD
Status last verified
Feb 2023
First submitted
6 May 2020
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PubMed 34515338

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19-7×19 CAR-T plus PD1 monoclonal antibody in people with Diffuse Large B-cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 13 inclusion and 9 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 6 Feb 2023. 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?

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?

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?

Objective response rate (time frame: 3 months). 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 NCT04381741, which also lists 1 linked publication.

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 6 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in