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Refractory or Relapsed Non-Hodgkin LymphomaPhase 1NCT03154775

Study of Safety and Efficacy of C-CAR011 in B-NHL Patients

A Phase 1 study testing C-CAR011 in people with Refractory or Relapsed Non-Hodgkin Lymphoma, run by Shanghai AbelZeta Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
C-CAR011
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
3 May 2017to 31 Dec 2018
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteered to participate in this study and signed informed consent
  • Age 18-70 years old, male or female
  • Relapsed or refractory B cell non-Hodgkin's lymphoma
  • 1 Histologically diagnosed as DLBCL(including PMBCL) or follicular lymphoma(grade Ⅲb) according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (1st edition 2017)
  • Progressive disease after the last standard chemotherapy regimens
  • Stable disease after the last standard chemotherapy regimens
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  • Relapsed within 12 months after prior autologous SCT
  • 2 Follicular lymphoma(stage Ⅲ-Ⅳ)(grade Ⅰ-Ⅲa)
  • At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
  • Less than 1 year between last chemotherapy and progression
  • 3 Mantle cell lymphoma
  • Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
  • Disease relapsed or progressed after most recent therapy
  • Relapsed within 12 months after prior autologous SCT
  • All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1)
  • At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5 cm)
  • Expected survival ≥ 12 weeks
  • ECOG score 0-1
  • Adequate pulmonary, hepatic, renal and cardiac function
  • At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy therapy) prior to leukapheresis,or at least 4 weeks from monoclonal antibody therapy prior to CAR T infusion
  • No contraindications of leukapheresis
  • Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial

Who cannot join

  • Prior treatment with CAR T therapy or any other genetically modified T cell therapy
  • Relapse after allogeneic hematopoietic stem cell transplantation
  • Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
  • Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected people
  • Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications
  • QT interval prolongation≥450 ms
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  • A history of epilepsy or other central nervous system disorders
  • No evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
  • The patient had a history of other primary cancers, with the following exceptions
  • 1 Excisional non-melanoma such as cutaneous basal cell carcinoma
  • 2 Cured in situ carcinoma such as cervical cancer, bladder cancer or breast cancer
  • Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
  • Used of systemic steroids within two weeks (using inhaled steroids is an exception)
  • Women who are pregnant or lactating or have breeding intent in 6 months
  • Participated in any other clinical trial within three months
  • The investigators believe that any increase in the risk of the subject or interference with the results of the trial

Trial locations and contacts

1 site in 1 country.

Aibin Liang, MD,Ph.D. contact

0086-021-66111019

lab7182@tongji.edu.cn

Ping Li, MD,Ph.D. contact

0086-021-66111015

lilyforever76@126.com

China1 site, 1 recruiting

  • Department of Hematology,Shanghai Tongji Hospital, Tongji University School of Medicin

    Shanghai

    Aibin Liang, MD,Ph.D., 0086-021-66111019, lab7182@tongji.edu.cn

    Ping Li, MD,Ph.D., 0086-021-66111015, lilyforever76@126.com

    Recruiting

Other trials in China

About this study

Official title: Study of Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T Cell(C-CAR011) Treatment in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).

Read the detailed description

This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up.

Being tested
C-CAR011
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • C-CAR011Biological

    Also called Anti-CD19 Chimeric Antigen Receptor T cell

    Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg

Study groups in NCT03154775
Study groupRoleWhat they receive
C-CAR011ExperimentalLymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene
Receives: Biological: C-CAR011

What is being measured

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

  1. Safety(Incidence of adverse events)

    Incidence of adverse events (AEs)

    Measured: 12 weeks

  2. Objective response rate (ORR)

    Measured: 12 weeks

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Measured: 12 months

  2. Duration of remission(DOR)

    Measured: 12 months

  3. Progression free survival(PFS)

    Measured: 12 months

  4. Overall survival(OS)

    Measured: 12 months

Timeline

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

  1. First posted16 May 2017
  2. Study start3 May 2017
  3. Primary completion30 Apr 2018 (estimated)
  4. Study completion31 Dec 2018 (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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03154775
Sponsor's protocol ID
CBMG-C2017003
Status last verified
May 2017
First submitted
13 May 2017
Last updated
16 May 2017
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 C-CAR011 in people with Refractory or Relapsed Non-Hodgkin Lymphoma, run by Shanghai AbelZeta Ltd. 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 22 inclusion and 16 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 16 May 2017. 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 Aibin Liang, MD,Ph.D. (0086-021-66111019, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety(Incidence of adverse events) (time frame: 12 weeks). 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 NCT03154775.

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 16 May 2017.

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