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B-cell LymphomaNCT04213469

PD1-CD19-CART in Patients With r/r B-cell Lymphoma

A study testing PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells in people with B-cell Lymphoma, run by Bioray Laboratories at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the treatment with PD1-CD19-CART. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
B-cell Lymphoma
What is being tested?
PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
13 Mar 2020to 10 Nov 2023
Phase
Interventional
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

  • Have the capacity to give informed consent;
  • ALL patients with the age between 18 and 70 years old;
  • Expected survival >3 moths;
  • With no severe heart and lung disease;
  • Previously confirmed diagnosis as CD19+ NHL within 6 months;
  • Hematological index as following, white blood cell (WBC)≥1.5×10^9/L，absolute neutrophil count (ANC) ≥0.8×10^9/L, Platelet count≥50×109/L, Hemoglobin (Hgb) ≥ 90mg/L, lymphocyte count≥ 0.4×10^9/L；
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  • Blood biochemical index as no more than 1.5* ULN, including total bilirubin (TBIL), transglutaminase (AST), alanine aminotransferase (AST), Creatinine (SCr), Urea in patients with no tumor metastasis in liver and kidney; Blood biochemical index no more than 5* ULN in patients with tumor metastasis in liver and kidney;
  • With a stable cardiac function, the left ventricular ejection fraction (LVEF) ≥ 55%;
  • Virological tests were negative for EBV, CMV, HIV, TP and HCV; a negative HBV DNA test is acceptable if HBsAg is positive;
  • ECOG <2;
  • Relapsed or refractory (r/r) NHL including, Diffuse large B cell lymphoma(DLBCL, NOS), stage Ⅲ-Ⅳ;Primary mediastinal large B-cell lymphoma (PMBL), stage Ⅲ-Ⅳ; High grade B-cell lymphoma (HGBL), stage Ⅲ-Ⅳ; Mantle cell lymphoma (MCL), stage Ⅲ-Ⅳ; follicular lymphoma (FL), stage Ⅲ-Ⅳ and with aggression. r/r NHL defined as following, demonstrate disease that persists or relapse after achieving complete response (CR) after > 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT), or not achieving CR after auto-HSCT.

Who cannot join

  • Pregnant or lactating women;
  • With a pregnancy plan in the next 2 years;
  • Prior treatment of anti-GVHD therapy;
  • Acceptance of allogeneic stem cell transplant (ASCT);
  • Isolated extramedullary relapse of ALL;
  • Severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases;
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  • Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment;
  • History of other type of maligant tumors;
  • Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: a Safety and Efficacy Evaluation of PD1-CD19-CART in Patients With Relapse/Refractory B-cell Lymphoma

This is an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the treatment with PD1-CD19-CART.

Read the detailed description

PD1-CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene integration and also PD1 knockout by one-step gene-editing. After completion of study treatment, subject participation for this study will be followed up to 15 years post T cell infusion.

Conditions
B-cell Lymphoma
Being tested
PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells
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.

  • PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T CellsBiological

    Also called PD1-CD19-CART

    Gene editing autologous T cells with anti-CD19 ScFv expression and knockout of PD1

Study groups in NCT04213469
Study groupRoleWhat they receive
PD1-CD19-CARTExperimentalPatients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of PD1-CD19-CART will be infused on day 0.
Receives: Biological: PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells

What is being measured

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

  1. MTD

    MTD will be determined based on DLTs observed during the first 28 days of study treatment.

    Measured: up to 28 days after T cell infusion

  2. RP2D

    RP2D will be determined based on MTD and efficiency during the first 28 days of study treatment.

    Measured: up to 28 days after T cell infusion

Secondary outcomes (2)

  1. Objective response rate (ORR)

    Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed.

    Measured: Baseline up to 3 months after T cell infusion

  2. Progress free survival (PFS)

    Assessed using modified Lugano classification response criteria for lymphoma (2014)

    Measured: Baseline up to 3 months after T cell infusion

Timeline

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

  1. First posted30 Dec 2019
  2. Study start13 Mar 2020
  3. Primary completion1 Nov 2021
  4. Study completion10 Nov 2023

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Patients will receive one of the three doses of 2\*10\^6/kg, 4\*10\^6/kg,6\*10\^6/kg.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04213469
Sponsor's protocol ID
2019-CAR-00CH1
Status last verified
Jan 2024
First submitted
26 Dec 2019
Last updated
5 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hu Y, Zu C, Zhang M, Wei G, Li W, Fu S, Hong R, Zhou L, Wu W, Cui J, Wang D, Du B, Liu M, Zhang J, Huang H. Safety and efficacy of CRISPR-based non-viral PD1 locus specifically integrated anti-CD19 CAR-T cells in patients with relapsed or refractory Non-Hodgkin's lymphoma: a first-in-human phase I study. EClinicalMedicine. 2023 May 18;60:102010. doi: 10.1016/j.eclinm.2023.102010. eCollection 2023 Jun.

    PubMed 37251628

  • Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

    PubMed 37192741

  • Zhang J, Hu Y, Yang J, Li W, Zhang M, Wang Q, Zhang L, Wei G, Tian Y, Zhao K, Chen A, Tan B, Cui J, Li D, Li Y, Qi Y, Wang D, Wu Y, Li D, Du B, Liu M, Huang H. Non-viral, specifically targeted CAR-T cells achieve high safety and efficacy in B-NHL. Nature. 2022 Sep;609(7926):369-374. doi: 10.1038/s41586-022-05140-y. Epub 2022 Aug 31.

    PubMed 36045296

  • Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121.

    PubMed 35468680

Questions about this trial

What is this clinical trial studying?

A study testing PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells in people with B-cell Lymphoma, run by Bioray Laboratories 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 11 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: finished, as of the sponsor's last update on 5 Jan 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

MTD (time frame: up to 28 days after T cell infusion). 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 NCT04213469, which also lists 4 linked publications.

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 5 Jan 2024.

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