B Cell LymphomaPhase 1NCT04036019
A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
A Phase 1 study testing CD20-directed CAR-T cells with CliniMACS Prodigy® system in people with B Cell Lymphoma, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- CD20-directed CAR-T cells with CliniMACS Prodigy® system
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to 20 Jun 2022
- 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
- The patient volunteered to participate in the study, and signed the Informed Consent
- Age 18-70 years old, male or female
- Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
- r/r lymphoma patients who received prior CD19 CAR-T therapy
- At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
- No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
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- No mAb treatment within 2 weeks before C-CAR066 infusion
- Adequate organ and bone marrow function
- No contraindications of apheresis
- Expected survival time > 3 months
- ECOG scores 0-1
Who cannot join
- Have a history of allergy to cellular products
- Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
- A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
- Patients with active CNS involvement
- Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
- Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
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- Live vaccination within 4 weeks before apheresis
- HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
- Have a history of alcoholism, drug addiction and mental illness
- Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
- Patients with severe fludarabine or cyclophosphamide hypersensitivity
- The patient has a history of other primary cancers, except for the following:
- Non-melanoma such as skin basal cell carcinoma cured by resection
- Cured carcinoma in situ such as cervical, bladder or breast cancer
- The investigators believe that there are other circumstances that are not suitable for the trial
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, 200065
About this study
Official title: A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.
Read the detailed description
This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
- Conditions
- B Cell Lymphoma
- Being tested
- CD20-directed CAR-T cells with CliniMACS Prodigy® system
- Keywords
- B cell lymphoma received prior CD19 CAR-T therapy
- 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.
CD20-directed CAR-T cells with CliniMACS Prodigy® systemBiological
Also called C-CAR066
Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
| Study group | Role | What they receive |
|---|---|---|
| C-CAR066 | Experimental | Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion Receives: Biological: CD20-directed CAR-T cells with CliniMACS Prodigy® system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
The incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 12 weeks after C-CAR066 infusion
Secondary outcomes (5)
Objective response rate (ORR)
The percentage of subjects who achieved complete response and partial response
Measured: Up to 24 months after C-CAR066 infusion
Complete response rate (CRR)
The percentage of subjects who achieved complete response
Measured: Up to 24 months after C-CAR066 infusion
Duration of response (DOR)
The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR066 infusion
Measured: Up to 24 months after C-CAR066 infusion
Progression free survival (PFS)
The time from C-CAR066 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Measured: Up to 24 months after C-CAR066 infusion
Overall survival (OS)
Time from C-CAR066 infusion to death from any cause
Measured: Up to 24 months after C-CAR066 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start20 Aug 2019
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
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 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Principal investigator, Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Aibin Liang, MD,Ph.D., Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036019
- Sponsor's protocol ID
- 0504-009
- Status last verified
- May 2024
- First submitted
- 8 Jul 2019
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li P, Liu W, Zhou L, Ye S, Zhu D, Huang J, Li J, Zheng C, Zhu S, Yao X, Zhu K, Yao Y, Qiu L, Liang A, Zou D. C-CAR066, a novel fully human anti-CD20 CAR-T therapy for relapsed or refractory large B-cell lymphoma after failure of anti-CD19 CAR-T therapy: A phase I clinical study. Am J Hematol. 2024 Dec;99(12):2306-2312. doi: 10.1002/ajh.27488. Epub 2024 Oct 1.
PubMed 39351902
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
- ClinicalTrials.gov ID
- NCT04036019
- Acronym / sponsor ID
- 0504-009
- Conditions
- B Cell Lymphoma
- Keywords
- B cell lymphoma received prior CD19 CAR-T therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 29 Jul 2019 (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-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.
Detailed description
This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-CAR066 | Experimental | Biological: CD20-directed CAR-T cells with CliniMACS Prodigy® systemAutologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient volunteered to participate in the study, and signed the Informed Consent
- Age 18-70 years old, male or female
- Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
- r/r lymphoma patients who received prior CD19 CAR-T therapy
- At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
Key exclusion criteria (15 listed)
- Have a history of allergy to cellular products
- Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
- A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
- Patients with active CNS involvement
- Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
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 |
|---|---|---|
| CD20-directed CAR-T cells with CliniMACS Prodigy® systemAlso: C-CAR066Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously | Biological | C-CAR066 |
Primary outcome
Incidence of adverse events
Time frame: Up to 12 weeks after C-CAR066 infusion
The incidence of treatment-emergent adverse events (TEAEs)
5 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 24 months after C-CAR066 infusion
Complete response rate (CRR)
Time frame: Up to 24 months after C-CAR066 infusion
Duration of response (DOR)
Time frame: Up to 24 months after C-CAR066 infusion
Progression free survival (PFS)
Time frame: Up to 24 months after C-CAR066 infusion
Overall survival (OS)
Time frame: Up to 24 months after C-CAR066 infusion
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 28 May 2024.
- Derived from this study: PubMed 39351902Li P, Liu W, Zhou L, Ye S, Zhu D, Huang J, Li J, Zheng C, Zhu S, Yao X, Zhu K, Yao Y, Qiu L, Liang A, Zou D. C-CAR066, a novel fully human anti-CD20 CAR-T therapy for relapsed or refractory large B-cell lymphoma after failure of anti-CD19 CAR-T therapy: A phase I clinical study. Am J Hematol. 2024 Dec;99(12):2306-2312. doi: 10.1002/ajh.27488. Epub 2024 Oct 1.
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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.
Aibin Liang, MD,Ph.D. principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
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 CD20-directed CAR-T cells with CliniMACS Prodigy® system in people with B Cell Lymphoma, run by Shanghai Tongji Hospital, Tongji University School of Medicine 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 11 inclusion and 15 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 28 May 2024. 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?
Incidence of adverse events (time frame: Up to 12 weeks after C-CAR066 infusion). 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 NCT04036019, 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 28 May 2024.