LeukemiaEarly Phase 1NCT05480501
Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
A Early Phase 1 study testing IM19 CAR-T cells in people with Leukemia, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
This is a open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Leukemia
- What is being tested?
- IM19 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2022to 1 Oct 2024
- Phase
- Early 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Relapsed or refractory B-ALL, defined as：1）Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia. 2）Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion. 3）Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen.
- Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI ± chemotherapy ；Ph + all patients with T315I mutation are not required to receive at least two TKI ± chemotherapy in the absence of effective TKI therapy.
- Morphological evidence of disease in bone marrow (at least 5% blasts).
- Aged 3 to 70 years.
- Estimated life expectancy >3 months.
- ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age < 16 years).
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- Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up.
- Adequate organ function.
- Volunteer to participate in this trial and sign on the informed consent.
Who cannot join
- Subjects with lsolated extramedullary disease relapse.
- Subjects with Burkitt's lymphoma.
- Subjects has obvious symptoms of central nervous system invasion and needs targeted treatment.
- Subjects has previously received gene product therapy.
- Subjects has graft-versus-host response（GVHD） and need to use immunosuppressants or GVHD ≥ grade 2 or being treated with anti GVHD or suffering from autoimmune diseases.
- Subjects has received chemotherapy or radiotherapy within 3 days before leukapheresis.
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- Subjects received systemic steroids within 5 days prior to leukapheresis.
- Subjects received drugs that stimulated the production of hematopoietic cells in the bone marrow for 5 days prior to leucapheresis.
- Subjects has participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study.
- Subjects received allogeneic cell therapy within 6 weeks before leukapheresis.
- Subjects with History or presence of CNS disorder.
- Subjects with HBV, HCV, HIV ,EBV,ECV or syphilis infection at the time of screening.
- Pregnant or lactating, or planning pregnancy within 180 days after the end of CAR-T cells infusion, or male patients whose partners plan pregnancy 180 days after their CAR-T cell infusion.
- Subjects with other tumors in the past 5 years.
- Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of China Medical University
Shenyang, Liaoning
Xiaojing Yan, M.D.
About this study
This is a open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia.
- Conditions
- Leukemia
- Being tested
- IM19 CAR-T cells
- Keywords
- CAR-T, B-cell Acute Lymphoblastic Leukemia
- Medical subject headings
- Leukemia, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM19 CAR-T cellsBiological
IM19 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
| Study group | Role | What they receive |
|---|---|---|
| IM19 CAR-T cells | Experimental | Not described Receives: Biological: IM19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 28 days after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )
Measured: Up to 24 weeks after CAR-T cell infusion
Secondary outcomes (5)
Objective response rate (ORR)
Measured: Up to 24 weeks after CAR-T cell infusion
Relapse free surviva（PFS）
Measured: Up to 24 weeks after CAR-T cell infusion
Duration of Response (DOR)
Measured: Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)
Measured: Up to 24 weeks after CAR-T cell infusion
Minimal residual disease（MRD）
Measured: Up to 24 weeks after CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start11 Jul 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojing Yan, M.D., Principal investigator, Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480501
- Sponsor's protocol ID
- YMCART1902
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05480501
- Acronym / sponsor ID
- YMCART1902
- Conditions
- Leukemia
- Keywords
- CAR-T, B-cell Acute Lymphoblastic Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 29 Jul 2022 (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 open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia.
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 cells | Experimental | Biological: IM19 CAR-T cells |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Relapsed or refractory B-ALL, defined as：1）Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia. 2）Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion. 3）Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen.
- Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI ± chemotherapy ；Ph + all patients with T315I mutation are not required to receive at least two TKI ± chemotherapy in the absence of effective TKI therapy.
- Morphological evidence of disease in bone marrow (at least 5% blasts).
- Aged 3 to 70 years.
- Estimated life expectancy >3 months.
Key exclusion criteria (15 listed)
- Subjects with lsolated extramedullary disease relapse.
- Subjects with Burkitt's lymphoma.
- Subjects has obvious symptoms of central nervous system invasion and needs targeted treatment.
- Subjects has previously received gene product therapy.
- Subjects has graft-versus-host response（GVHD） and need to use immunosuppressants or GVHD ≥ grade 2 or being treated with anti GVHD or suffering from autoimmune diseases.
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-T cellsIM19 CAR-T cells administrated in a dosage to be selected by physician from a specific range. | Biological | IM19 CAR-T cells |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 28 days after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )
Time frame: Up to 24 weeks after CAR-T cell infusion
5 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 24 weeks after CAR-T cell infusion
Relapse free surviva（PFS）
Time frame: Up to 24 weeks after CAR-T cell infusion
Duration of Response (DOR)
Time frame: Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)
Time frame: Up to 24 weeks after CAR-T cell infusion
Minimal residual disease（MRD）
Time frame: Up to 24 weeks after CAR-T cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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.
Xiaojing Yan, M.D. principal investigator
Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IM19 CAR-T cells 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 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: status not confirmed, as of the sponsor's last update on 29 Jul 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Fei Wu (+8615801390058, wufei@imunopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 28 days after CAR-T cell infusion). 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 29 Jul 2022.