Acute Lymphoblastic Leukemia(ALL)NCT03327285
C-CAR011 Treatment in Subjects With ALL After HSCT
A study testing C-CAR011 in people with Acute Lymphoblastic Leukemia(ALL), run by Peking University People's Hospital at 1 site in China.
Trial summary
This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia(ALL)
- What is being tested?
- C-CAR011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 30 Apr 2021
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 15-65 years old, male or female.
- Volunteered to participate in this study and signed informed consent.
- Meet the two populations above.
- Histologically diagnosed as CD19+B-ALL.
- 100% T lymphocytes of donor.
- Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
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- Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
- Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
- Expected survival ≧ 3 months.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Who cannot join
- History of allergy to cellular products.
- Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L.
- The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
- Severe uncontrolled infection (mycotic, bacterial, virus and so on).
- Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
- The subjects were treated CART cells or DLI after HSCT.
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- Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
- Any genetically modified T cell therapy.
- History of heavy drinking, drug taking or mental disease.
- Participated in any other clinical trial within one month prior to enrollment.
- Women who are pregnant or lactating or have breeding intent in 6 months.
- The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044
About this study
Official title: A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）
This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
Read the detailed description
A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10^6CAR+T cells/kg
- Conditions
- Acute Lymphoblastic Leukemia(ALL)
- Being tested
- C-CAR011
- Keywords
- Acute lymphoblastic leukemia, Hematopoietic stem cell transplantation, Anti-CD19 chimeric antigen receptor T-cell
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CAR011Biological
Also called Anti-CD19 chimeric antigen receptor T cells (C-CAR011)
CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)
| Study group | Role | What they receive |
|---|---|---|
| C-CAR011 | Experimental | The amount of cells received：1.0-5.0×10^6 CAR+T cells/kg Receives: Biological: C-CAR011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
TEAEs evaluated after C-CAR011 infusion
Measured: 2 months
GVHD
GVHD evaluated after C-CAR011 infusion
Measured: 2 months
Secondary outcomes (4)
Recurrence rate
Recurrence rate
Measured: 6 and 12 months
OS
Overall survival (OS) after C-CAR011 infusion
Measured: 12 months
PFS
Progression free survival（PFS）after C-CAR011 infusion
Measured: 12 months
Remission rate
MRD negative after C-CAR011 infusion
Measured: 2 weeks to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Mar 2018
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia(ALL)Studies of the same condition, open and under way.
- More trials run by Peking University People's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Principal investigator, Xiaojun Huang,MD, Peking University People's Hospital
- Investigators
- Xiaojun Huang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327285
- Sponsor's protocol ID
- 2017PHB033-01
- Other IDs
- CBMG-C2017004
- Status last verified
- Sep 2020
- First submitted
- 17 Aug 2017
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）
- ClinicalTrials.gov ID
- NCT03327285
- Acronym / sponsor ID
- 2017PHB033-01
- Conditions
- Acute Lymphoblastic Leukemia(ALL)
- Keywords
- Acute lymphoblastic leukemia, Hematopoietic stem cell transplantation, Anti-CD19 chimeric antigen receptor T-cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 31 Oct 2017 (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, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
Detailed description
A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10^6CAR+T cells/kg
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| C-CAR011 | Experimental | Biological: C-CAR011The amount of cells received：1.0-5.0×10^6 CAR+T cells/kg |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age 15-65 years old, male or female.
- Volunteered to participate in this study and signed informed consent.
- Meet the two populations above.
- Histologically diagnosed as CD19+B-ALL.
- 100% T lymphocytes of donor.
Key exclusion criteria (12 listed)
- History of allergy to cellular products.
- Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L.
- The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
- Severe uncontrolled infection (mycotic, bacterial, virus and so on).
- Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
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-CAR011Also: Anti-CD19 chimeric antigen receptor T cells (C-CAR011)CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011) | Biological | C-CAR011 |
Primary outcome
TEAEs
Time frame: 2 months
TEAEs evaluated after C-CAR011 infusion
GVHD
Time frame: 2 months
GVHD evaluated after C-CAR011 infusion
4 secondary outcomes
Recurrence rate
Time frame: 6 and 12 months
OS
Time frame: 12 months
PFS
Time frame: 12 months
Remission rate
Time frame: 2 weeks to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Xiaojun Huang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-CAR011 in people with Acute Lymphoblastic Leukemia(ALL), run by Peking University People's 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 10 inclusion and 12 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 1 Oct 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.
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?
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?
TEAEs (time frame: 2 months). The study lists 2 primary outcomes in all. 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 1 Oct 2020.