Refractory or Relapsed B-cell Non-Hodgkin LymphomaPhase 1NCT03299738
A Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-NHL
A Phase 1 study testing C-CAR011 in people with Refractory or Relapsed B-cell Non-Hodgkin Lymphoma, run by Shanghai AbelZeta Ltd. at 1 site in China.
Trial summary
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory or Relapsed B-cell Non-Hodgkin Lymphoma
- 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- Dec 2017to Aug 2019
- 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
- Relapse 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 (2017 Version 1)
- Progressive disease after the last standard chemotherapy regimens per the IWG Response Criteria (1999)
- Stable disease after the last standard chemotherapy regimens (at least 4 cycles of first-line therapy or 2 cycles of later-line therapy) per the IWG Response Criteria (1999)
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- Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT)
- 2. Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
- At least 2 combination chemotherapy regimens (excluding single agent monoclonal antibody)
- Relapse or progressive disease within 1 year after last chemotherapy regimens
- 3. Mantle cell lymphoma
- Relapse after 1st CR or persistent disease, and not eligible or appropriate for SCT
- Relapse or progressive disease within 1 year after the last chemotherapy regimens
- Relapse or progressive disease within 12 months after autologous SCT
- All subjects must have received anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline-containing chemotherapy regimens according 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
- Left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography)
- No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air
- At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy) prior to leukapheresis, or at least 4 weeks from monoclonal antibody therapy prior to CAR T cell therapy
- 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
- History of allergy to cellular products
- Laboratory tests: absolute neutrophil count < 1.0 × 10^9 /L, platelet count < 50 × 10^9 /L, serum albumin < 30 g/L, serum bilirubin > 1.5 ULN, serum creatinine > ULN, ALT/AST > 3 ULN
- History of CAR T cell therapy or any other genetically modified T cell therapy
- Relapse after allogeneic hematopoietic stem cell transplantation
- Active infections that require treatment (uncomplicated urinary tract infections and bacterial pharyngitis are allowed), prophylactic antibiotic, antiviral and antifungal treatment are permitted
- Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired or congenital immune deficiency diseases, including but not limited to HIV infection
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- Class III or IV heart failure according to the NYHA Heart Failure Classifications
- QT interval prolongation ≥ 450 ms
- History of epilepsy or other central nervous system disorders
- Evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
- History of other primary cancers, with the following exceptions
- Excisional non-melanoma (e.g. cutaneous basal cell carcinoma)
- Cured in situ carcinoma (e.g. cervical cancer, bladder cancer, breast cancer)
- Autoimmune diseases that require treatment, immune deficiency diseases or other diseases that require immunosuppressive therapy
- Used of systemic steroids within two weeks (using inhaled steroids is an exception)
- Women who are pregnant or lactating, or who have breeding intent in 6 months
- Participated in any other clinical trial within three months
- Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed
Trial locations and contacts
1 site in 1 country.
Huilai Zhang contact
China1 site
Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital
Tianjin
Huilai Zhang
About this study
Official title: A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-cell Non-Hodgkin Lymphoma (NHL)
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
Read the detailed description
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, B-Cell
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 group | Role | What they receive |
|---|---|---|
| C-CAR011 | Experimental | Lymphocytes 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.
Safety: Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 12 weeks
Overall response rate (ORR)
Measured: 12 weeks
Secondary outcomes (5)
Overall response rate (ORR)
Measured: 6 months
Overall response rate (ORR)
Measured: 12 months
Duration of remission (DOR)
Measured: 12 months
Progression free survival (PFS)
Measured: 12 months
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.
- First posted3 Oct 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory or Relapsed B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huilai Zhang, Principal investigator, Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299738
- Sponsor's protocol ID
- CBMG-C2017006
- Status last verified
- Dec 2017
- First submitted
- 28 Sep 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-cell Non-Hodgkin Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT03299738
- Acronym / sponsor ID
- CBMG-C2017006
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai AbelZeta Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
Detailed description
The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), Treatment and Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-CAR011 | Experimental | Biological: C-CAR011Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Volunteered to participate in this study and signed informed consent
- Age 18-70 years old, male or female
- Relapse or refractory B cell non-Hodgkin's lymphoma
- All subjects must have received anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline-containing chemotherapy regimens according 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)
Key exclusion criteria (18 listed)
- History of allergy to cellular products
- Laboratory tests: absolute neutrophil count < 1.0 × 10^9 /L, platelet count < 50 × 10^9 /L, serum albumin < 30 g/L, serum bilirubin > 1.5 ULN, serum creatinine > ULN, ALT/AST > 3 ULN
- History of CAR T cell therapy or any other genetically modified T cell therapy
- Relapse after allogeneic hematopoietic stem cell transplantation
- Active infections that require treatment (uncomplicated urinary tract infections and bacterial pharyngitis are allowed), prophylactic antibiotic, antiviral and antifungal treatment are permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-CAR011Also: Anti-CD19 Chimeric Antigen Receptor T cellAutologous 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 | Biological | C-CAR011 |
Primary outcome
Safety: Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 12 weeks
Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
Overall response rate (ORR)
Time frame: 12 weeks
5 secondary outcomes
Overall response rate (ORR)
Time frame: 6 months
Overall response rate (ORR)
Time frame: 12 months
Duration of remission (DOR)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huilai Zhang contact
Huilai Zhang principal investigator
Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C-CAR011 in people with Refractory or Relapsed B-cell 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 23 inclusion and 18 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 19 Dec 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 Huilai Zhang (+86-022-23340123), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs) (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?
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 19 Dec 2017.