AzTrials
AzTrials

B Cell LymphomaPhase 1NCT04007978

Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy for Relapsed Refractory B-cell Malignancies

A Phase 1 study testing Third generation CAR-T cells in people with B Cell Lymphoma and Acute Lymphoblastic Leukemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell Malignancies. Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
B Cell Lymphoma, Acute Lymphoblastic Leukemia
What is being tested?
Third generation CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
5 Aug 2019to 30 Dec 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 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
  • Male or female patients aged 14 to 70 years (including 14 and 70 years old).
  • Pathological and histological examination confirmed CD22+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies.
  • A.Refractory/relapsed B-cell lymphoblastic leukemia (Meeting one of the following)
  • Recurrence within 6 months after first remission.
  • Primary refractory disease which cannnot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.
Show all 29Show fewer
  • Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.
  • Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.
  • B.Refractory/relapsed B-cell lymphoma (Meeting 1 of the first 4 items plus item 5)
  • Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
  • Achieved CR after standard chemotherapy, but relapsed within 6 months.
  • 2 or more relapses after CR.
  • Not suitable for HSCT, or abandon HSCT due to various restrictions, or relapse after HSCT.
  • Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.
  • B-cell malignancies include the following three types
  • B-cell acute lymphoblastic leukemia (B-ALL)
  • Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL)
  • Invasive B-cell lymphoma (DLBCL, BL, MCL)
  • Having a measurable or evaluable lesion
  • Patients with lymphoma require a single lesion≥15mm or 2 or more lesions≥10mm.
  • Patients with leukemia require persistent positive or positive relapse of bone marrow MRD.
  • Patient's main organs functioning well
  • Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L
  • Renal function: Creatinine < 220μmol/L.
  • Pulmonary function: Indoor oxygen saturation≥95%.
  • Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
  • The patients did not receive any antitumor treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before enrollment, and the toxicity related to previous treatments had returned to < 1 level at enrollment (except for low grade toxicity such as alopecia).
  • The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
  • Patient ECOG score≤ 2, estimated survival time≥3 months.

Who cannot join

  • Have a history of epilepsy or other central nervous system diseases.
  • Women who are pregnant (urine/blood pregnancy test positive) or lactating.
  • Male or female with a pregnancy plan in the next 1 year.
  • Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment.
  • Uncontrolled infectious disease within 4 weeks prior to enrollment.
  • Active hepatitis B/C virus infection.
Show all 14Show fewer
  • HIV infected patients.
  • Suffering from a serious autoimmune disease or immunodeficiency disease.
  • The patient is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
  • The patient participated in other clinical trials within 6 weeks prior to enrollment.
  • Systemic use of corticosteroids within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
  • Suffering from mental diseases.
  • Patient has drug abuse/addiction.
  • According to the researcher's judgment, the patient has other unsuitable enrollment conditions.

Trial locations and contacts

1 site in 1 country.

Yu Hu, M.D., Ph.D contact

86-13986183871

dr_huyu@126.com

Heng Mei, M.D., Ph.D contact

86-13886160811

hmei@hust.edu.cn

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Yu Hu, M.D., Ph.D, 86-13986183871, dr_huyu@126.com

    Heng Mei, M.D., Ph.D, 86-13886160811, hmei@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Anti-CD22 CAR-T Therapy in Patients With Relapsed/Refractory B-cell Malignancies: a Single-center, Open-label, Single-arm Clinical Study

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell Malignancies.

Read the detailed description

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B-cell malignancies. CAR consists of single chain variable fragment (scFv) and activation domain of T cell. In preclinical study, the researchers constructed a third generation CAR containing CD137 and CD28 costimulatory domains.

This study aims to evaluate the safety and effectiveness of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell Malignancies.

Being tested
Third generation CAR-T cells
Medical subject headings
Lymphoma, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Third generation CAR-T cellsGenetic

    Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.

Study groups in NCT04007978
Study groupRoleWhat they receive
Third generation CAR-T cellsExperimentalPatients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
Receives: Genetic: Third generation CAR-T cells

What is being measured

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

  1. Number of participants with adverse events

    Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).

    Measured: 3 years

Secondary outcomes (7)

  1. One-month remission rate

    Response of B-ALL to CAR-T therapy was assessed on day 30 (±2), against the National Comprehensive Cancer Network (NCCN, Version 1.2015).

    Measured: 1 month

  2. Overall survival

    OS was calculated from the first CAR-T cell infusion to death or last follow-up (censored).

    Measured: 3 years

  3. Event-free survival

    EFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).

    Measured: 3 years

  4. Relapse-free survival

    RFS was calculated from the first CAR-T cell infusion to relapse or last visit (censored).

    Measured: 3 years

  5. Rate of anti-CD22 CAR-T cells in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) rate of CAR-T cells were determined by means of flow cytometry.

    Measured: 3 years

  6. Quantity of anti-CD22 CAR-T cells in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) quantity of CAR-T cells were determined by means of flow cytometry.

    Measured: 3 years

  7. Quantity of anti-CD22 CAR copies in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) quantity of anti-CD22 CAR copies were determined by means of qPCR.

    Measured: 3 years

Timeline

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

  1. First posted5 Jul 2019
  2. Study start5 Aug 2019
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Dec 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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04007978
Sponsor's protocol ID
WHUH-CART-CD22-01
Status last verified
Aug 2019
First submitted
28 Jun 2019
Last updated
7 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Third generation CAR-T cells in people with B Cell Lymphoma and Acute Lymphoblastic Leukemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 29 inclusion and 14 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 7 Aug 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 Yu Hu, M.D., Ph.D (86-13986183871, dr_huyu@126.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 adverse events (time frame: 3 years). 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 NCT04007978.

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 7 Aug 2019.

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