RefractoryPhase 1NCT03881774
Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
A Phase 1 study testing CAR-T cells in people with Refractory and Relapsed, run by Henan Cancer Hospital at 2 sites in China.
Trial summary
Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Refractory, Relapsed, B Cell Lymphoma
- What is being tested?
- CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 27 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 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- expected lifespan >3 months
- patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
- KPS >70
- for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
- enough function of heart, liver, kidney and bone marrow
- no history of severy allergy
Show all 10Show fewer
- no other serious diseases that conflict with this plan
- no other history of malignancy
- no serious mental illness
- patients and their families members agree to participate in this clinical study and sign the Informed Consent Form
Who cannot join
- pregnant or lactating women
- vevere infectious or viral diseases
- active hepatitis B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
- participated in other clinical studies in the past 3 months or who have been treated with other gene products;
- others that other investigators consider not suitable for this clinical study
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- 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
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yongping Song, M.D, +86-37165587795, songyongping2018@126.com
About this study
Official title: Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared
Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells
Read the detailed description
CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.
- Conditions
- Refractory, Relapsed, B Cell Lymphoma, B Cell Leukemia
- Being tested
- CAR-T cells
- Medical subject headings
- Recurrence, Lymphoma, B-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cellsBiological
Also called cord blood derived CAR-T cells
collecting cord 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 CAR-T cell with a dose of 0.5-3x106/kg
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | cord blood derived CAR T cells group Receives: Biological: 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 (4)
objective response rate
the proportion of patients with CR or PR
Measured: three months
progression-free survival
from the date of enrollment to the first date of progression detected
Measured: one year
overall survival
from the date of enrollment to the date of death
Measured: one year
copy number of CAR-T
copy number of CAR-T in blood and bone marrow
Measured: six months
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 start27 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 RefractoryStudies 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
- CAR-T cell group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03881774
- Sponsor's protocol ID
- HenanCH CART 2-4
- Status last verified
- Mar 2019
- First submitted
- 16 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared
- ClinicalTrials.gov ID
- NCT03881774
- Acronym / sponsor ID
- HenanCH CART 2-4
- Conditions
- Refractory, Relapsed, B Cell Lymphoma, B Cell Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Henan Hualong Biotechnology Company
- Study start
- 27 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 cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells
Detailed description
CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CAR-T cell group
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Biological: CAR-T cellscord blood derived CAR T cells group |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- expected lifespan >3 months
- patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
- KPS >70
- for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
- enough function of heart, liver, kidney and bone marrow
Key exclusion criteria (6 listed)
- pregnant or lactating women
- vevere infectious or viral diseases
- active hepatitis B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
- participated in other clinical studies in the past 3 months or who 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 |
|---|---|---|
| CAR-T cellsAlso: cord blood derived CAR-T cellscollecting cord 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 CAR-T cell with a dose of 0.5-3x106/kg | Biological | experimental arm |
Primary outcome
occurrence of study related adverse events
Time frame: one year
safety of CAR-T cells
4 secondary outcomes
objective response rate
Time frame: three months
progression-free survival
Time frame: one year
overall survival
Time frame: one year
copy number of CAR-T
Time frame: six months
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.
- Individual participant dataSharing planned: No
Related trials for Refractory
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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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.
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 CAR-T cells in people with Refractory and Relapsed, 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.