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LymphomaPhase 1/2NCT05155215

Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma

A Phase 1/2 study testing IM19 CAR-T cells, Cyclophosphamide and Fludarabine in people with Lymphoma and Lymphoma, Mantle-Cell, run by Beijing Immunochina Medical Science & Technology Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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 phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IM19 CAR-T cells, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
No sites listed yet
Study dates
31 Dec 2021to 28 Feb 2023
Phase
Phase 1/2
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

  • Subjects with relapsed or refractory mantle cell lymphoma, diagnosed as CD19 positive by cytology or histology；
  • Subjects have measurable positive lesion according to Lugano Classification;
  • ≥ 18 years old;
  • Expected survival is greater than 3 months；
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • The toxicity caused by the previous treatment has stabilized or recovered to ≤1 level (except for the case where the investigator judges that it has no clinical significance);
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  • Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up;
  • Adequate organ function;
  • Adequate vascular access for leukapheresis procedure;
  • Volunteer to participate in this trial and sign on the informed consent.

Who cannot join

  • Central nervous system (CNS) involvement by lymphoma;
  • Received allo-hematopoietic stem cell transplantation or organ transplantation therapy previously；
  • Subjects with cardiac atrial or cardiac ventricular lymphoma involvement；
  • Serous effusion with symptoms of compression;
  • History of autoimmune disease (eg Crohn's disease, rheumatoid arthritis, systemic lupus) within the last 2 years;
  • Presence of acute or chronic graft-versus-host disease (GVHD);
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  • Use prohibited drugs or treatments within a specified period of time before cell collection；
  • Received anti-CD19 target therapy (unless the CD19 target test is still positive);
  • Received CAR-T cell therapy;
  • Received the study drug within 4 weeks before cell collection. However, if the trial treatment is invalid or the disease progresses, and at least 5 half-lives have passed before the cell collection, it is allowed to enter the group;
  • Received radiotherapy within 6 weeks prior to cell collection, including large bone marrow areas such as the sternum or pelvis. Subjects who have progressed in the radiotherapy site or have PET-positive lesions in other non-irradiated sites are eligible to be included in the group;
  • Received donor lymphocyte infusion (DLI) within 6 weeks before CAR-T cell infusion;
  • If anti-PD1, PD-L1 and other immunotherapies have been used before CAR-T cell reinfusion, at least 5 half-lives must elapse between the last medication and before CAR-T cell reinfusion;
  • History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posteriorreversible encephalopathy syndrome, or any autoimmune disease with CNS involvement;
  • Received autologous transplantation within 6 weeks before the start of screening;
  • Subjects has HBV, HCV, HIV ,EBV,ECV or syphilis infection at the time of screening;
  • Live vaccine received within 6 weeks before the start of screening;
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,active arrhythmias, or other clinically significant cardiac disease within 6 months of enrollment;
  • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment;
  • History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease-free for at least 3 years；
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and bacterial pharyngitis are permitted if the investigator evaluates that it can be controlled by treatment, they can be included in the group;
  • In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

Trial locations and contacts

No sites are listed yet.

Fei Wu, MD contact

+8615801390058

wufei@immunochina.com

About this study

Official title: A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma

This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects

Being tested
IM19 CAR-T cells, Cyclophosphamide, Fludarabine
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders

What participants receive

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

  • IM19 CAR-T cellsBiological

    IM19 CAR-T cells will be administered at dose level: 100×10^6 CAR-T cells or 200×10^6 CAR-T cells

  • CyclophosphamideDrug

    300 mg/m^2 per day for 3 days (IV)

  • FludarabineDrug

    30 mg/m^2 per day for 3 days (IV)

Study groups in NCT05155215
Study groupRoleWhat they receive
IM19 CAR-T cellsExperimentalNot described
Receives: Biological: IM19 CAR-T cells; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0

    Measured: Up to 28 days after IM19 CAR-T cell infusion

  2. Objective response rate (ORR)

    ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to Lugano(2014)

    Measured: At 3 months after IM19 CAR-T cell infusion

Secondary outcomes (6)

  1. Objective response rate (ORR)

    ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to Lugano(2014)

    Measured: At 28 days and 6 months after IM19 CAR-T cell infusion

  2. Progression-free survival (PFS)

    PFS, defined as the time from CAR-T cell infusion to the first occurrence of disease progression or death from any cause (whichever occurs first) , as determined by the investigator according to Lugano(2014)

    Measured: Up to 24 weeks after IM19 CAR-T cell infusion

  3. Duration of Response (DOR)

    DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to Lugano(2014)

    Measured: Up to 24 weeks after IM19 CAR-T cell infusion

  4. Overall survival (OS)

    OS , defined as the time from IM19 CAR-T cell infusion to death from any cause

    Measured: Up to 24 weeks after CAR-T cell infusion

  5. Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)

    The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR

    Measured: Up to 24 weeks after IM19 CAR-T cell infusion

  6. Anti-therapeutic IM19 CAR-T cells antibody

    Measured: Up to 24 weeks after IM19 CAR-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 posted13 Dec 2021
  2. Study start31 Dec 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion28 Feb 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155215
Sponsor's protocol ID
SD46
Status last verified
Nov 2021
First submitted
30 Nov 2021
Last updated
13 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IM19 CAR-T cells, Cyclophosphamide and Fludarabine in people with Lymphoma and Lymphoma, Mantle-Cell, run by Beijing Immunochina Medical Science & Technology Co., Ltd..

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 10 inclusion and 22 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 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Fei Wu, MD (+8615801390058, wufei@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0 (time frame: Up to 28 days after IM19 CAR-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 NCT05155215.

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 13 Dec 2021.

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