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B Cell LymphomaPhase 1NCT03854994

CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia

A Phase 1 study testing Anti-CD19 CAR-T Cells Injection in people with B Cell Lymphoma and B-cell Acute Lymphoblastic Leukemia, run by Yan'an Affiliated Hospital of Kunming Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia （B-ALL）. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anti-CD19 CAR-T Cells Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Aug 2018to 1 Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;
  • 18 Years and older, Male and female;
  • Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program;
  • B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:
  • B-cell acute lymphoblastic leukemia;
  • Indolent B-cell lymphomas;
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  • Aggressive B-cell lymphoma; 4、 Subjects:
  • Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.
  • 5、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements:
  • Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) <3 ×upper limit of normal (ULN);
  • Total bilirubin ≤34.2μmol/L;
  • Serum creatinine<220μmol/L;
  • Baseline oxygen saturation≥95%;
  • Left ventricular ejection fraction（LVEF）≥40%. 7、 Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2，Expected survival≥3 months;

Who cannot join

  • Pregnant (urine/blood pregnancy test positive) or lactating women;
  • Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
  • Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment;
  • Active or uncontrollable infection within four weeks prior to enrollment;
  • Patients with active hepatitis B/C;
  • HIV-infected patients;
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  • Severe autoimmune or immunodeficiency disorders;
  • Patients are allergic to macromolecule drugs such as antigens or cytokines;
  • Subjects participated in other clinical trials within 6 weeks before enrollment;
  • Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
  • Mental illness;
  • Drug abuse/addiction;
  • The investigators consider other conditions unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

Peixian Zhang contact

86-0871-63211268

px29@163.com

China1 site, 1 recruiting

  • Kunming Yan'an Hospital, Oncology Department

    Kunming, Yunnan, 650000

    Lan Shi, 86-18988158897, shi_lanlan@yahoo.com

    Jiabao Song, 86-15663656065, jiabaosong668@gmail.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Trial of Anti-CD19 Chimeric Antigen Receptor With Synthetic Biology Optimizing Nano-vector T Cells Injection for Subjects With Relapsed/Refractory/High-risk B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia

The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia （B-ALL）.

Read the detailed description

The investigators designed an KD-019 Chimeric Antigen Receptor(CAR) with FMC63 single-chain antibody fragment (Scfv). This CAR has a CD8 hinge and transmembrane domains and a 4-1BB costimulatory domain; T cells expressing this CAR release relatively low levels of cytokines. Subjects with relapsed/refractory CD19-positive B-cell Lymphoma and B-ALL can participate if all eligibility criteria are met. Subjects receive chemotherapy prior to the infusion of KD-019 CAR-T cells. After the infusion, subjects will accept follow-up for side effects and effect of KD-019 CAR-T cells by the sponsor. Study procedures may be performed while hospitalized.

Being tested
Anti-CD19 CAR-T Cells Injection
Medical subject headings
Lymphoma, B-Cell, Burkitt Lymphoma

What participants receive

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

  • Anti-CD19 CAR-T Cells InjectionBiological

    Also called KD-019 CAR-T cells Injection

    Autologous genetically modified anti-CD19 CAR transduced T cells

Study groups in NCT03854994
Study groupRoleWhat they receive
Anti-CD19 CAR-T Cells InjectionExperimentalDosage form：injection Dosage:1-5x10^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes Frequency: total one time
Receives: Biological: Anti-CD19 CAR-T Cells Injection

What is being measured

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

  1. Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.

    The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.

    Measured: 0 to 14 days post infusion

  2. Copies numbers of CAR in peripheral blood (PB)

    Copies numbers of CAR in peripheral blood (PB)

    Measured: 1 year post infusion

Secondary outcomes (3)

  1. Overall survival

    For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason

    Measured: 2 years post infusion

  2. Duration of Response after administration

    Duration of Response after administration

    Measured: 2 years post infusion

  3. Progress Free Survival after administration

    Progress Free Survival after administration

    Measured: 2 years post infusion

Timeline

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

  1. First posted26 Feb 2019
  2. Study start1 Aug 2018
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion1 Aug 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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03854994
Sponsor's protocol ID
201707202
Status last verified
Feb 2019
First submitted
20 Feb 2019
Last updated
26 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-CD19 CAR-T Cells Injection in people with B Cell Lymphoma and B-cell Acute Lymphoblastic Leukemia, run by Yan'an Affiliated Hospital of Kunming Medical University 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 14 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 26 Feb 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?

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?

Contact Peixian Zhang (86-0871-63211268, px29@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability. (time frame: 0 to 14 days post 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 NCT03854994.

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 26 Feb 2019.

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