LeukemiaNCT04336501
Efficacy and Safety Evaluation of IM19 CAR-T Cell Therapy for MRD+ After Transplantation
A study testing IM19 CAR-T in people with Leukemia, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Leukemia
- What is being tested?
- IM19 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Dec 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be aged 3 to 65 years
- It was consistent with the diagnosis of CD19+ B-All with MRD+ in allo- hsct transplantation
- The immunotyping was determined to be CD19+ B-All
- The T lymphocytes in the subjects were 100% donor T lymphocytes
- No chemotherapy or antibody treatment was received 2 weeks before cell therapy
- Left ventricular ejection fraction (LVEF) ≥50% and centerless inclusion were diagnosed by echocardiography
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- The subjects had no pulmonary active infection
- Blood oxygen saturation at the fingertips ≥ 92%
- Estimated survival of >3 months
- ECOG physical condition level 0~1
Who cannot join
- Unwilling to accept IM19 CAR-T cell therapy, do not agree to signInformed consent of subject
- Subjects are allergic to the components of cellular products
- Total serum bilirubin ≥ 2.0mg/dl、Serum albumin < 35g/L、ALT and AST were more than 3 times of the upper limit of the normal range. Blood creatinine ≥ 2.0mg/dl;Platelet < 20 x 109 / L
- Subjects had activity level II-IV aGVHD, or activityModerate to severe cGVHD
- The subjects had a severe failure to control the infection
- Subject with known central nervous system leukemia (CNS2 or CNS3)
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- Subjects were treated with CAR T cells or DLT after transplantation
- The subjects developed bone marrow failure syndrome after allo-hsct transplantation
- The subjects had previously received other gene treatments
- The subjects had a history of alcohol, drug use or mental illness
- Subjects were enrolled in any other clinical investigator within 1 month prior to screening
- Female subjects: 1) were pregnant/lactating, or 2) had a pregnancy plan during the study period,Or 3) fertile and unable to use effective contraception
- The researchers believe there are other conditions that may not be appropriate for the study
Trial locations and contacts
1 site in 1 country.
zheng li xu contact
China1 site, 1 recruiting
- Recruiting
Peking University people's hospita
Beijing, Beijing Municipality, 000000
xiang yu zhao, MD, 13520122292, xyz@163.com
About this study
Official title: Efficacy Study About Donor Derived CD19-target T Cell to Treat B-ALL Post Hematopoietic Stem Cell Transplantation
Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (allo-hsct) for the treatment of refractory recurrent acute b-lymphoblastic leukemia (b-all), the overall survival rate of 3 years after transplantation was about 10%. The overall survival rate at 3 years was about 70 percent. In the early stage, the investigators established the monitoring method of leukemia micro-residual disease, effectively screened out the high-risk group of recurrence, combined with the new relapse treatment method, successfully implemented the stratification and even personalized dry prediction of leukemia recurrence for the first time in the world, and reduced the recurrence rate of the high-risk group by 30%. However, the therapeutic targeting is not strong, and up to 30% of patients will develop graft versus host disease, which seriously affects the survival of patients. The use of CAR repair T cells (CAR T) to target CD19 in the treatment of refractory recurrent b-all was effective, and the use of CAR T in the treatment of recurrent b-all after transplantation did not increase the risk of GVHD. This clinical study mainly discussed the safety and efficacy of donor targeted cd19-t cells after allo-hsct in the treatment of acute b-lymphocytic leukemia with minimal residual disease. It is expected that the recurrence rate will be reduced while the incidence of acute GVHD after transplantation will not be increase
- Conditions
- Leukemia
- Being tested
- IM19 CAR-T
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM19 CAR-TBiological
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later
| Study group | Role | What they receive |
|---|---|---|
| IM19 CAR-T group | Experimental | Subject will be treated with IM19 car-t cells Receives: Biological: IM19 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR at 6 month
Objective response at 6 month
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xiang yu zhao, MD, Principal investigator, Peking University people's hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336501
- Sponsor's protocol ID
- YMCART20190423
- Status last verified
- Dec 2020
- First submitted
- 3 Apr 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study About Donor Derived CD19-target T Cell to Treat B-ALL Post Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04336501
- Acronym / sponsor ID
- YMCART20190423
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 7 Apr 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.
Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-hsct) for the treatment of refractory recurrent acute b-lymphoblastic leukemia (b-all), the overall survival rate of 3 years after transplantation was about 10%. The overall survival rate at 3 years was about 70 percent. In the early stage, the investigators established the monitoring method of leukemia micro-residual disease, effectively screened out the high-risk group of recurrence, combined with the new relapse treatment method, successfully implemented the stratification and even personalized dry prediction of leukemia recurrence for the first time in the world, and reduced the recurrence rate of the high-risk group by 30%. However, the therapeutic targeting is not strong, and up to 30% of patients will develop graft versus host disease, which seriously affects the survival of patients. The use of CAR repair T cells (CAR T) to target CD19 in the treatment of refractory recurrent b-all was effective, and the use of CAR T in the treatment of recurrent b-all after transplantation did not increase the risk of GVHD. This clinical study mainly discussed the safety and efficacy of donor targeted cd19-t cells after allo-hsct in the treatment of acute b-lymphocytic leukemia with minimal residual disease. It is expected that the recurrence rate will be reduced while the incidence of acute GVHD after transplantation will not be increase
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM19 CAR-T group | Experimental | Biological: IM19 CAR-TSubject will be treated with IM19 car-t cells |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- To be aged 3 to 65 years
- It was consistent with the diagnosis of CD19+ B-All with MRD+ in allo- hsct transplantation
- The immunotyping was determined to be CD19+ B-All
- The T lymphocytes in the subjects were 100% donor T lymphocytes
- No chemotherapy or antibody treatment was received 2 weeks before cell therapy
Key exclusion criteria (13 listed)
- Unwilling to accept IM19 CAR-T cell therapy, do not agree to signInformed consent of subject
- Subjects are allergic to the components of cellular products
- Total serum bilirubin ≥ 2.0mg/dl、Serum albumin < 35g/L、ALT and AST were more than 3 times of the upper limit of the normal range. Blood creatinine ≥ 2.0mg/dl;Platelet < 20 x 109 / L
- Subjects had activity level II-IV aGVHD, or activityModerate to severe cGVHD
- The subjects had a severe failure to control the infection
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 |
|---|---|---|
| IM19 CAR-TAll patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later | Biological | IM19 CAR-T group |
Primary outcome
ORR at 6 month
Time frame: 6 months
Objective response at 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- 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.
zheng li xu contact
xiang yu zhao, MD principal investigator
Peking University people's hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IM19 CAR-T in people with Leukemia, run by Beijing Immunochina Medical Science & Technology Co., Ltd. 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 13 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 17 Dec 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?
Contact xiang yu zhao, MD (13520122292, xyz80421@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR at 6 month (time frame: 6 months). 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 17 Dec 2020.