B-cell Non-Hodgkin LymphomaPhase 1NCT03483688
A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects
A Phase 1 study testing CD19-directed CAR-T cells in people with B-cell Non-Hodgkin Lymphoma, run by Peking Union Medical College Hospital 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 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
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma
- What is being tested?
- CD19-directed CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2018to 10 Jan 2020
- 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 ,Histologically diagnosed as DLBCL,follicular lymphoma and Mantle cell lymphoma according to the NCCN. nonHodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)
- DLBCL and Follicular Lymphoma (stage Ⅲ-Ⅳ, grade Ⅲb).
- Progressive disease after the last standard chemotherapy regimens.
- Stable disease after the last standard chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later-line therapy).
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- Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT).
- Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
- Relapse or progressive disease within 1 year after the last standard chemotherapy regimens(At least 2 combination chemotherapy regimens).
- Stable disease after the last standard chemotherapy regimens(at least 2 cycles of combination chemotherapy regimens).
- 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(at least 4 cycles of first-line therapy or 2 cycles of later- line therapy).
- 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 ≥ 1.5cm).
- 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.
- 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.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: A Phase Ⅰb Study Evaluating 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
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Being tested
- CD19-directed CAR-T cells
- Keywords
- B-cell Non-Hodgkin Lymphoma, Refractory, Relapsed
- Medical subject headings
- Lymphoma, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-directed CAR-T cellsBiological
Also called Anti-CD19 chimeric antigen receptor T cells (C- CAR011)
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 |
|---|---|---|
| CD19-directed CAR-T cells | Experimental | Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene Receives: Biological: CD19-directed CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 12 weeks
Secondary outcomes (4)
Overall response rate (ORR)
The ORR will be assessed at weeks 4 ，weeks 12 ，months 6 and months 12
Measured: 12 months
Duration of remission (DOR)
The DOR will be assessed at months 12
Measured: 12 months
Progression free survival (PFS)
The PFS will be assessed at months 12
Measured: 12 months
Overall survival rate（OSR）
The OSR will be assessed at weeks 12 ，months 6 and months 12
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 posted30 Mar 2018
- Study start6 Mar 2018
- Primary completion10 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Sponsor
- Investigators
- Daobin Zhou, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483688
- Sponsor's protocol ID
- CBMG-C2017007
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang L, Zhang Y, Zhou DB. [Anti-CD19 CART (C-CAR011) Therapy for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2021 Aug;29(4):1141-1147. doi: 10.19746/j.cnki.issn.1009-2137.2021.04.019. Chinese.
PubMed 34362494
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb Study Evaluating 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
- ClinicalTrials.gov ID
- NCT03483688
- Acronym / sponsor ID
- CBMG-C2017007
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Keywords
- B-cell Non-Hodgkin Lymphoma, Refractory, Relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 30 Mar 2018 (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 therapy 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 |
|---|---|---|
| CD19-directed CAR-T cells | Experimental | Biological: CD19-directed CAR-T cellsLymphocytes 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 ,Histologically diagnosed as DLBCL,follicular lymphoma and Mantle cell lymphoma according to the NCCN. nonHodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)
- 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 ≥ 1.5cm).
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 |
|---|---|---|
| CD19-directed CAR-T cellsAlso: Anti-CD19 chimeric antigen receptor T cells (C- CAR011)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 | CD19-directed CAR-T cells |
Primary outcome
AE
Time frame: 12 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
4 secondary outcomes
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 rate（OSR）
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 34362494Zhang L, Zhang Y, Zhou DB. [Anti-CD19 CART (C-CAR011) Therapy for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2021 Aug;29(4):1141-1147. doi: 10.19746/j.cnki.issn.1009-2137.2021.04.019. Chinese.
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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.
Daobin Zhou principal investigator
Peking Union Medical College 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 CD19-directed CAR-T cells in people with B-cell Non-Hodgkin Lymphoma, run by Peking Union Medical College Hospital 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: finished, as of the sponsor's last update on 5 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: 12 weeks). 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 NCT03483688, 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 5 Mar 2020.