B-Cell Lymphoma Stage IPhase 1NCT03881761
CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
A Phase 1 study testing CD19/CD20 bispecific CAR-T cells in people with B-Cell Lymphoma Stage I and Refractory, run by Henan Cancer Hospital at 2 sites in China.
Trial summary
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- B-Cell Lymphoma Stage I, Refractory, Relapsed
- What is being tested?
- CD19/CD20 bispecific CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2019to 31 Jan 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- expected lifetime>3 months
- CD19/CD20 positive relapsed/refractory B cell lymphoma
- KPS>70
- at least one measurable lesion according to RECIST 1.1
- enough function of hear, liver, kidney and bone marrow
- no history of severe allergies
Show all 10Show fewer
- no other history of malignancy
- no other diseases that conflict with this regimen
- no serious mental illness
- patient or family member sign informed consent
Who cannot join
- Pregnant or lactating women
- Severe infectious or viral disease
- Active B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
- participated in other clinical studies in the last 3 months, or have been treated with other gene products
- Others not appropriate to participate in this study examined by the investigators
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450000
Yongping Song, Dr., +86-37165587795, songyongping2018@126.com
Quanli Gao, Dr.
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Quanli Gao, M.D, +86-15038171966, gaoquanli2015@126.com
Lu Han, M.D, +86-13838583031, luhan0377@163.com
About this study
Official title: Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
Read the detailed description
CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.
- Conditions
- B-Cell Lymphoma Stage I, Refractory, Relapsed
- Being tested
- CD19/CD20 bispecific CAR-T cells
- 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/CD20 bispecific CAR-T cellsBiological
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | CAR-T cell group Receives: Biological: CD19/CD20 bispecific CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of study related adverse events
safety of CAR-T cells
Measured: one year
Secondary outcomes (3)
objective response rate
proportion of patients with complete response and partial response
Measured: three months
survival time of CAR-T cells in vivo
from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo
Measured: one year
progression-free survival
the enrollment to the first time that disease progression is detected
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Feb 2019
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Lymphoma Stage IStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Model description
- transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Henan Hualong Biotechnology Company
- Responsible party
- Sponsor
- Investigators
- Yongping Song, Dr., Study chair, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881761
- Sponsor's protocol ID
- HenanCH CART 2-3
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03881761
- Acronym / sponsor ID
- HenanCH CART 2-3
- Conditions
- B-Cell Lymphoma Stage I, Refractory, Relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Henan Hualong Biotechnology Company
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 19 Mar 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.
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
Detailed description
CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Biological: CD19/CD20 bispecific CAR-T cellsCAR-T cell group |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- expected lifetime>3 months
- CD19/CD20 positive relapsed/refractory B cell lymphoma
- KPS>70
- at least one measurable lesion according to RECIST 1.1
- enough function of hear, liver, kidney and bone marrow
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Severe infectious or viral disease
- Active B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
- participated in other clinical studies in the last 3 months, or have been treated with other gene products
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/CD20 bispecific CAR-T cellscollecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg | Biological | experimental arm |
Primary outcome
occurrence of study related adverse events
Time frame: one year
safety of CAR-T cells
3 secondary outcomes
objective response rate
Time frame: three months
survival time of CAR-T cells in vivo
Time frame: one year
progression-free survival
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Related trials for B-Cell Lymphoma Stage I
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Relapsed
RecruitingPhase 1/2
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Mature B-Cell Non-Hodgkin Lymphoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Yongping Song, Dr. study chair
Henan Cancer Hospital
2 sites 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/CD20 bispecific CAR-T cells in people with B-Cell Lymphoma Stage I and Refractory, run by Henan Cancer Hospital at 2 sites 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 10 inclusion and 6 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yongping Song, Dr. (+86-37165587795, songyongping2018@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of study related adverse events (time frame: one year). 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 21 Mar 2019.