LeukemiaPhase 1/2NCT05309213
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 Phase 1/2 study testing IM19 CAR-T cells in people with Leukemia, run by Beijing Immunochina Medical Science & Technology Co., Ltd..
Trial summary
This is a phase I/II, open-label, multicenter study 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 25 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
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Jun 2025
- Phase
- Phase 1/2
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Relapsed or refractory B-ALL, defined as:
- Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia.
- Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion.
- 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).
Show all 12Show fewer
- Aged 3 to 25 years, either sex;
- Estimated life expectancy >3 months;
- ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50;
- 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
- Isolated extramedullary disease relapse；
- Burkitt's lymphoma；
- Patient has obvious symptoms of central nervous system invasion and needs targeted treatment;
- Patient has previously received gene product therapy;
- Patients have 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;
- Patient received chemotherapy or radiotherapy within 3 days before leukapheresis
Show all 15Show fewer
- Patient used systemic steroids within 5 days before leucapheresis, except those who were recently or currently using inhaled steroids;
- Patients who used drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before leucapheresis;
- Patients have participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study;
- Patient received allogeneic cell therapy within 6 weeks before CAR-T cell infusion, such as donor lymphocyte infusion(DLI)；
- History or presence of CNS disorder, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia / hemorrhage / cerebral infarction), brain edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome or mental disease;
- Patients has 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;
- Patients 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
No sites are listed yet.
About this study
Official title: A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
This is a phase I/II, open-label, multicenter study 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 will be administered at dose level:5 x 10^4 CAR+ T cells/kg,1x 10^5 CAR+ T cells/kg,3 x 10^5 CAR+ T cells/kg,1 x 10^6 CAR+ T cells/kg
| 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 Treatment Related 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)
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
Measured: Up to 24 weeks after CAR-T cell infusion
Secondary outcomes (2)
Objective response rate (ORR)
Measured: At 28 days, 3 months and 6 months after CAR-T cell infusion
Anti-therapeutic IM19 CAR-T cells antibody
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 posted4 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qian Jiang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309213
- Sponsor's protocol ID
- SD3
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pei X, Lv M, Zhao X, Liu Z, Deng L, Zhou Z, Ding Y, Liu J, Zhang L, Jiang Q, Zhang X, Lu X, He T, Huang X, Zhao X. Rapid Manufactured CAR-T Cells enriched for CD45RA-negative T cells Exhibit Superior Persistence Compared to Conventional CAR-T Therapy. Cancer Lett. 2026 Oct 2:218865. doi: 10.1016/j.canlet.2026.218865. Online ahead of print.
PubMed 42826832
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Study 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
- NCT05309213
- Acronym / sponsor ID
- SD3
- Conditions
- Leukemia
- Keywords
- CAR-T, B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 Apr 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 phase I/II, open-label, multicenter study 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
- Sequential
- 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 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Relapsed or refractory B-ALL, defined as:
- 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 25 years, either sex;
- Estimated life expectancy >3 months;
Key exclusion criteria (15 listed)
- Isolated extramedullary disease relapse；
- Burkitt's lymphoma；
- Patient has obvious symptoms of central nervous system invasion and needs targeted treatment;
- Patient has previously received gene product therapy;
- Patients have 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 will be administered at dose level:5 x 10^4 CAR+ T cells/kg,1x 10^5 CAR+ T cells/kg,3 x 10^5 CAR+ T cells/kg,1 x 10^6 CAR+ T cells/kg | Biological | IM19 CAR-T cells |
Primary outcome
Incidence of Treatment Related 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
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
2 secondary outcomes
Objective response rate (ORR)
Time frame: At 28 days, 3 months and 6 months after CAR-T cell infusion
Anti-therapeutic IM19 CAR-T cells antibody
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 4 Apr 2022.
- Derived from this study: PubMed 42826832Pei X, Lv M, Zhao X, Liu Z, Deng L, Zhou Z, Ding Y, Liu J, Zhang L, Jiang Q, Zhang X, Lu X, He T, Huang X, Zhao X. Rapid Manufactured CAR-T Cells enriched for CD45RA-negative T cells Exhibit Superior Persistence Compared to Conventional CAR-T Therapy. Cancer Lett. 2026 Oct 2:218865. doi: 10.1016/j.canlet.2026.218865. Online ahead of print.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Qian Jiang principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IM19 CAR-T cells in people with Leukemia, run by Beijing Immunochina Medical Science & Technology Co., Ltd..
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 12 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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, MD (+8615801390058, wufei@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Related 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?
On the ClinicalTrials.gov record for NCT05309213, which also lists 1 linked publication.
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 4 Apr 2022.