Diffuse Large B Cell LymphomaPhase 1NCT04316624
A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
A Phase 1 study testing C-CAR066 in people with Diffuse Large B Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- C-CAR066
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2019to 8 Feb 2023
- 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 75 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 18-75 years old, male or female
- Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
- r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
- At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
- Adequate organ and bone marrow fuction
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- 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 inhibitors
- 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 peripheral blood 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.
About this study
Official title: A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL 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
- Diffuse Large B Cell Lymphoma
- Being tested
- C-CAR066
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CAR066Drug
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: Drug: C-CAR066 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 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 posted20 Mar 2020
- Study start29 Sep 2019
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
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 Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Sponsor
- Investigators
- Dehui Zou, Principal investigator, Institute of Hematology & Blood Diseases Hostipal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316624
- Sponsor's protocol ID
- QT2019008
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2020
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 11 Feb 2026. 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 Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
- ClinicalTrials.gov ID
- NCT04316624
- Acronym / sponsor ID
- QT2019008
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 20 Mar 2020 (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 and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL 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 | Drug: C-CAR066Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient volunteered to participate in the study, and signed the Informed Consent
- Age 18-75 years old, male or female
- Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
- r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
- At least 2 weeks 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 inhibitors
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-CAR066Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously | Drug | C-CAR066 |
Primary outcome
The 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 11 Feb 2026.
- 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.
- Individual participant dataSharing planned: No
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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.
Dehui Zou principal investigator
Institute of Hematology & Blood Diseases Hostipal
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-CAR066 in people with Diffuse Large B Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China 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 9 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 11 Feb 2026. 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?
The 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 NCT04316624, 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 11 Feb 2026.