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Recurrent Adult Diffuse Large Cell LymphomaPhase 1/2MeCARNCT02652910

Memory-enriched CAR-T Cells Immunotherapy for B Cell Lymphoma

A Phase 1/2 study testing CD19.CAR-T cells in people with Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Follicular Lymphoma, run by Xinqiao Hospital of Chongqing 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 The sponsor has not verified this record for over two years, so it may be out of date.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 goal of this clinical trial is to study how approaches for manufacturing chimeric antigen receptor (CAR)-modified T (CAR-T) cells affect their in vivo persistence and therapeutic efficacy against B lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CD19.CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Dec 2015to Dec 2019
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 Years to 70 Years, Male and female;
  • Expected survival > 12 weeks;
  • Performance score 0-2;
  • Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions;
  • Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
  • Disease recurrence after stem cell transplantation;
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  • Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
  • Creatinine < 2.5 mg/dl;
  • ALT/AST < 3x normal;
  • Bilirubin < 2.0 mg/dl;
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis;
  • Take contraceptive measures before recruit to this trial;
  • Written voluntary informed consent is given.

Who cannot join

  • Patients with symptoms of central nervous system
  • Accompanied by other malignant tumor
  • Active hepatitis B or C, HIV infection
  • Any other diseases could affect the outcome of this trial
  • Suffering severe cardiovascular or respiratory disease
  • Poorly controlled hypertension
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  • A history of mental illness and poorly controlled
  • Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
  • Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
  • Reaching a steady dose if receiving anticoagulant therapy before assignment
  • Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  • Pregnant or lactating women
  • Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Trial locations and contacts

1 site in 1 country.

Qingzhu Jia, M.D. contact

+(86)-152-2333-4184

jiaqingzhu0801@outlook.com

China1 site, 1 recruiting

  • Department of Oncology

    Chongqing, Chongqing Municipality, 400000

    Qingzhu Jia, MD, 152-2333-4184 ext. +86, jiaqinghzu0801@outlook.com

    Recruiting

Other trials in China

About this study

Official title: A Two-Arm, Single-Center, Open-Label Pilot Study of IL-2 Programmed or IL-7/IL-15 Programmed Anti-CD19:TCRz:CD28 T-cells in Patient With CD19-Positive Lymphoma That is Resistant or Refractory to Chemotherapy

The goal of this clinical trial is to study how approaches for manufacturing chimeric antigen receptor (CAR)-modified T (CAR-T) cells affect their in vivo persistence and therapeutic efficacy against B lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs combine the variable region of an antibody with T-cell signaling moieties to confer T-cell activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to MHC down regulation by tumors. However, defined by the activation and contraction program of their mother cells, the persistency and function of CAR-T cells are also restricted by the protocol of manufacturing. Previous clinical studies largely utilized interleukin-2 (IL-2) for the ex vivo expansion of CAR-T cells, which preferentially generate CAR-T cells with characteristics of terminally differentiated effector cells. Our preliminary data indicated that two common gamma chain cytokines, IL-7 and IL-15, can help to selectively expand CAR-T cells with various memory phenotypes. CAR-T Cells prepared under this condition resulted in improved therapeutic efficacy in preclinical animal models. This clinical investigation is to test a hypothesis whether IL-7/IL-15-programmed anti-CD19 CAR-T cells persist longer in lymphoma patients after infusion and whether the persistency of CAR-T cells can lead to improved anti-lymphoma efficacy.

Read the detailed description

Primary Objectives

  1. To determine the safety and feasibility of CD19.CAR-T cells manufactured through IL-7/IL-15-mediated expansion or IL-2-mediated expansion
  2. To determine in vivo dynamics and persistency of IL-7/IL-15 programmed CD19.CAR-T cells.
  3. To determine the efficacy of IL-7/IL-15 programmed CD19.CAR-T cells in treating patients with CD19-positive lymphoma

Secondary Objectives

  1. To determine whether the IL-7/IL-15 programmed CD19.CAR-T cells are superior to the IL-2 programmed cells as measured by their in vivo persistence post infusion
  2. To determine whether the IL-7/IL-15 programmed CD19.CAR-T cells are superior to the IL-2 programmed cells as measured by their efficacy in lymphoma therapy
  3. To assess the dynamics of intratumoral infiltration of CD19.CAR-T cells.
  4. To correlate the subsets and differentiation of CD19.CAR-T cells to observed anti-tumor efficacy
Being tested
CD19.CAR-T cells
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell

What participants receive

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

  • CD19.CAR-T cellsDrug

    Also called DSCAR01

    Retroviral vector-transduced autologous T cells to express CD19-specific CARs

Study groups in NCT02652910
Study groupRoleWhat they receive
IL-2 programmed CD19.CAR-T cellsExperimentalAdministrated with IL-2 programmed CD19.CAR-T cells on day 0,1,2 in the lympho-depleted patients
Receives: Drug: CD19.CAR-T cells
IL-7/IL-15 programmed CD19.CAR-T cellsExperimentalAdministrated with IL-7/IL-15 programmed CD19.CAR-T cells on day 0,1,2 in the lympho-depleted patients
Receives: Drug: CD19.CAR-T cells

What is being measured

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

  1. Phase 1: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

    Measured: 4 weeks

  2. Phase 2: Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

    Measured: 8 weeks

  3. Phase 2: Comparison of overall complete remission rate for the two arms

    Measured: One year

Secondary outcomes (5)

  1. Duration of remission

    Measured: One year

  2. Minimum residual disease negative remission rate

    Measured: 8 weeks

  3. Duration of CAR-positive T cells in circulation

    Measured: 6 months

  4. Total number of CAR-positive T cells infiltrated into lymphoma tissue

    Measured: 6 months

  5. Overall survival

    Measured: One year

Timeline

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

  1. First posted12 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionJun 2019 (estimated)
  4. Study completionDec 2019 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02652910
Sponsor's protocol ID
20151117
Acronym
MeCAR
Status last verified
Apr 2016
First submitted
18 Nov 2015
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
Yes

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 1/2 study testing CD19.CAR-T cells in people with Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Follicular Lymphoma, run by Xinqiao Hospital of Chongqing 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 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 27 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 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 Qingzhu Jia, M.D. (+(86)-152-2333-4184, jiaqingzhu0801@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (time frame: 4 weeks). The study lists 3 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 NCT02652910, 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 27 Feb 2019.

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