Leukemia, B-cellPhase 1NCT06209671
INS19 CAR-T Cells for the Treatment of Relapsed or Refractory Acute B Lymphoblastic Leukemia
A Phase 1 study testing INS19 CAR-T Cells in people with Leukemia, B-cell, run by Beijing Immunochina Medical Science & Technology Co., Ltd..
Trial summary
This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety, tolerability, and pharmacokinetic profile of INS19 CAR-T cells for the treatment of patients with relapsed or refractory acute B lymphoblastic leukemia Read more about this study
- Who is it for?
- Ages 3 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukemia, B-cell
- What is being tested?
- INS19 CAR-T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 15 Jan 2026
- 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 3 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with relapsed or refractory acute B-lymphoblastic leukemia who meet one of the following criteria and are diagnosed as CD19 positive by flow cytometry or histology, with the following provisions for the patient's prior treatment:
- 2 or more bone marrow relapses;
- Chemoresistance: relapse after chemotherapy and failure to achieve complete remission (MRD >1%) with at least 1 additional course of chemotherapy;
- Relapse after autologous or allogeneic hematopoietic stem cell transplantation: time from transplantation to reinfusion is at least greater than 6 months;
- Primary refractory: complete remission not achieved after two courses of standard chemotherapy (MRD >1%); 2. Philadelphia chromosome-positive (Ph+) patients are required to meet the following criteria: they should have received at least one relapse or refractory treatment with a tyrosine kinase inhibitor (TKI) agent ± chemotherapy or be intolerant of relapse or refractory to treatment with a TKI analog ± chemotherapy; Ph+ acute lymphoblastic leukemia (ALL) known to be accompanied by a T315I mutation, in the absence of an effective treatment with a TKI analog, is not require patients to be treated with TKI analogs ± chemotherapy; 3. Patients must have evaluable evidence of disease (bone marrow morphology suggestive of ≥5% primitive naive cells or bone marrow MRD >1%); 4. Age 3-70, including boundary values; 5. Expected survival of 3 months or more; 6. Eastern Cooperative Oncology Group (ECOG) score of 0-1 for patients aged 16 years and older (refer to Attachment 1); Lansky score of >50 for patients under 16 years of age (refer to Attachment 2); 7. Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception for the duration of the trial until the last follow-up visit; male subjects whose partners are of childbearing potential agree to use effective contraception for the duration of the trial until the last follow-up visit; 8. Blood cell analysis meet the requirement 9. Adequate organ function 10. Toxicity due to prior therapy has stabilized or recovered to ≤ grade 1 or is not considered clinically significant by the investigator; 11. Volunteer to participate in this trial and sign on the informed consent
Who cannot join
- Isolated extramedullary disease relapse;
- Leukemia patients with symptoms of significant central nervous system invasion and requiring targeted therapy;
- Prior treatment with a gene product;
- Plasmapheresis with symptoms of compression (e.g., pleural effusion, abdominal effusion);
- Patients with cardiac involvement and gastrointestinal involvement;
- Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;
Show all 27Show fewer
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, active arrhythmia, or other clinically significant cardiac disease within 6 months prior to the start of screening; patients with NYHA scores greater than Class I (or is it Class II);
- Patients with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to the start of screening; or requiring long-term antiplatelet therapy; or undergoing anticoagulation therapy;
- Allergy to the study drug and related ingredients (e.g., albumin);
- Those with Graft-versus-host disease (GVHD) requiring immunosuppression; or GVHD ≥ grade 2 or on anti-GVHD therapy; use of any medication for the treatment of GVHD within 4 weeks prior to enrollment; or autoimmune disease;
- Provisions for prior medication:
- Systemic therapy (including chemotherapy, TKI inhibitors, and belintuzumab) 1 week or 5 half-lives prior to the cell collection period; clofarabine or cladribine within 3 months prior to enrollment, or pembrolizumab within 3 weeks prior to enrollment;
- Those who have combined systemic steroid medications within 5 days prior to the cell collection period (except those who have recently or are currently using topical or inhaled steroids);
- Those who have used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to the cell collection period;
- Patients who have participated in another clinical study within 1 month prior to screening; or who are scheduled to participate in a clinical trial of another drug during this study; however, enrollment will be allowed if the treatment is ineffective or the disease has progressed during the trial and at least 5 half-lives have elapsed prior to cell collection;
- INS19 CAR-T cells have received allogeneic cell therapy, such as donor lymphocyte transfusion, within 6 weeks prior to transfusion;
- Prior CAR-T cell therapy;
- Prior treatment with anti-CD19 target (unless CD19 target test remains positive);
- If immunotherapy such as anti-PD1, PD-L1, etc. has been used prior to INS19 CAR-T cell infusion, at least 4 weeks must have elapsed after the last dose and prior to INS19 CAR-T cell infusion;
- Live vaccination within 6 weeks prior to the start of screening. ii;
- Prior or clinically significant CNS disorders at screening, such as epilepsy, epileptic seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders;
- Patients has HBV, HCV, HIV ,EBV, CMV 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;
- History of malignancy other than non-melanotic skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) (unless in a disease-free state for at least 5 years);
- Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, if the investigator assesses that they can be controlled by curative treatment, are eligible for enrollment.
- Comorbid hereditary bone marrow failure-related syndromes such as Fanconi anemia, Kostmann syndrome, Schwachman syndrome, or other bone marrow failure syndromes, except Down syndrome;
- The presence of any factors affecting compliance with the protocol, or the unwillingness or inability of the subject to comply with the procedures required in the study protocol, as judged by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of INS19 CAR-T Cells for the Treatment of Relapsed or Refractory Acute B Lymphoblastic Leukemia
This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety, tolerability, and pharmacokinetic profile of INS19 CAR-T cells for the treatment of patients with relapsed or refractory acute B lymphoblastic leukemia
Read the detailed description
The study is planned to enroll 9-12 patients with relapsed or refractory acute B-lymphoblastic leukemia in a modified "3+3" design with two dose groups of 1×10^7 cells and 2×10^7 cells (dose halved for subjects weighing <40 kg). Each dose group is planned to enroll 3-6 subjects to assess safety, and ultimately the SRC will decide whether to continue to add escalating dose groups or to conduct an extension study in a specific dose group based on available safety and efficacy information, with 3-6 subjects to be enrolled in the extension phase.
This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group.
- Conditions
- Leukemia, B-cell
- Being tested
- INS19 CAR-T Cells
- Keywords
- INS19 CAR-T, Acute B-lymphoblastic leukemia
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS19 CAR-T CellsBiological
INS19 CAR-T Cells, 1-2×10^7 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/m^2/day (D-5~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/m^2/day (D-5~D-3), determined by tumor burden at baseline.
| Study group | Role | What they receive |
|---|---|---|
| INS19 CAR-T Cells | Experimental | After preconditioning with chemotherapy, INS19 CAR-T Cells will be evaluated Receives: Biological: INS19 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)
Incidence of adverse events associated with CAR-T treatment, abnormal clinically significant laboratory findings, including dose-limiting toxicity (DLT) and maximum-tolerated Dose (MTD).
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 (8)
Objective response rate (ORR)
Objective response rate (ORR)
Measured: At 28 days, 3 months and 6 months after CAR-T cell infusion
Relapse free survival (RFS)
Relapse free survival (RFS)
Measured: At 28 days, 3 months and 6 months after CAR-T cell infusion
Relapse free survival (RFS)
Relapse free survival (RFS)
Measured: Up to 24 months after CAR-T cell infusion
Duration of response (DOR)
Duration of response (DOR)
Measured: Up to 24 months after CAR-T cell infusion
Overall survival (OS)
Overall survival (OS)
Measured: Up to 24 months after CAR-T cell infusion
Minimal residual disease (MRD) negative rate
Minimal residual disease (MRD) negative rate
Measured: Up to 24 months after CAR-T cell infusion
Minimal residual disease (MRD) negative duration
Minimal residual disease (MRD) negative duration
Measured: Up to 24 months after CAR-T cell infusion
Anti-therapeutic INS19 CAR-T cells antibody
Anti-therapeutic INS19 CAR-T cells antibody
Measured: Up to 24 months 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 posted17 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2026 (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 Leukemia, B-cellStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
- Investigators
- Xiangyu Zhao, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209671
- Sponsor's protocol ID
- INS1901
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of INS19 CAR-T Cells for the Treatment of Relapsed or Refractory Acute B Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06209671
- Acronym / sponsor ID
- INS1901
- Conditions
- Leukemia, B-cell
- Keywords
- INS19 CAR-T, Acute B-lymphoblastic leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 17 Jan 2024 (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 study, a single-center, open, single-dose clinical study, was designed to evaluate the safety, tolerability, and pharmacokinetic profile of INS19 CAR-T cells for the treatment of patients with relapsed or refractory acute B lymphoblastic leukemia
Detailed description
The study is planned to enroll 9-12 patients with relapsed or refractory acute B-lymphoblastic leukemia in a modified "3+3" design with two dose groups of 1×10^7 cells and 2×10^7 cells (dose halved for subjects weighing <40 kg). Each dose group is planned to enroll 3-6 subjects to assess safety, and ultimately the SRC will decide whether to continue to add escalating dose groups or to conduct an extension study in a specific dose group based on available safety and efficacy information, with 3-6 subjects to be enrolled in the extension phase.
This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INS19 CAR-T Cells | Experimental | Biological: INS19 CAR-T CellsAfter preconditioning with chemotherapy, INS19 CAR-T Cells will be evaluated |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients with relapsed or refractory acute B-lymphoblastic leukemia who meet one of the following criteria and are diagnosed as CD19 positive by flow cytometry or histology, with the following provisions for the patient's prior treatment:
- 2 or more bone marrow relapses;
- Chemoresistance: relapse after chemotherapy and failure to achieve complete remission (MRD >1%) with at least 1 additional course of chemotherapy;
- Relapse after autologous or allogeneic hematopoietic stem cell transplantation: time from transplantation to reinfusion is at least greater than 6 months;
- Primary refractory: complete remission not achieved after two courses of standard chemotherapy (MRD >1%); 2. Philadelphia chromosome-positive (Ph+) patients are required to meet the following criteria: they should have received at least one relapse or refractory treatment with a tyrosine kinase inhibitor (TKI) agent ± chemotherapy or be intolerant of relapse or refractory to treatment with a TKI analog ± chemotherapy; Ph+ acute lymphoblastic leukemia (ALL) known to be accompanied by a T315I mutation, in the absence of an effective treatment with a TKI analog, is not require patients to be treated with TKI analogs ± chemotherapy; 3. Patients must have evaluable evidence of disease (bone marrow morphology suggestive of ≥5% primitive naive cells or bone marrow MRD >1%); 4. Age 3-70, including boundary values; 5. Expected survival of 3 months or more; 6. Eastern Cooperative Oncology Group (ECOG) score of 0-1 for patients aged 16 years and older (refer to Attachment 1); Lansky score of >50 for patients under 16 years of age (refer to Attachment 2); 7. Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception for the duration of the trial until the last follow-up visit; male subjects whose partners are of childbearing potential agree to use effective contraception for the duration of the trial until the last follow-up visit; 8. Blood cell analysis meet the requirement 9. Adequate organ function 10. Toxicity due to prior therapy has stabilized or recovered to ≤ grade 1 or is not considered clinically significant by the investigator; 11. Volunteer to participate in this trial and sign on the informed consent
Key exclusion criteria (27 listed)
- Isolated extramedullary disease relapse;
- Leukemia patients with symptoms of significant central nervous system invasion and requiring targeted therapy;
- Prior treatment with a gene product;
- Plasmapheresis with symptoms of compression (e.g., pleural effusion, abdominal effusion);
- Patients with cardiac involvement and gastrointestinal involvement;
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 |
|---|---|---|
| INS19 CAR-T CellsINS19 CAR-T Cells, 1-2×10^7 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/m^2/day (D-5~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/m^2/day (D-5~D-3), determined by tumor burden at baseline. | Biological | INS19 CAR-T Cells |
Primary outcome
Incidence of Treatment Related adverse events (AEs)
Time frame: Up to 28 days after CAR-T cell infusion
Incidence of adverse events associated with CAR-T treatment, abnormal clinically significant laboratory findings, including dose-limiting toxicity (DLT) and maximum-tolerated Dose (MTD).
Persistence of CAR-T cells
Time frame: Up to 24 weeks after CAR-T cell infusion
cell counts and cell percentage in peripheral blood and bone marrow
8 secondary outcomes
Objective response rate (ORR)
Time frame: At 28 days, 3 months and 6 months after CAR-T cell infusion
Relapse free survival (RFS)
Time frame: At 28 days, 3 months and 6 months after CAR-T cell infusion
Relapse free survival (RFS)
Time frame: Up to 24 months after CAR-T cell infusion
Duration of response (DOR)
Time frame: Up to 24 months after CAR-T cell infusion
Overall survival (OS)
Time frame: Up to 24 months after CAR-T cell infusion
Minimal residual disease (MRD) negative rate
Time frame: Up to 24 months after CAR-T cell infusion
Minimal residual disease (MRD) negative duration
Time frame: Up to 24 months after CAR-T cell infusion
Anti-therapeutic INS19 CAR-T cells antibody
Time frame: Up to 24 months 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 17 Jan 2024.
- 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.
- 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.
Xiangyu Zhao, PhD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INS19 CAR-T Cells in people with Leukemia, B-cell, 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 5 inclusion and 27 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 Jan 2024. 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 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 Xiangyu Zhao, PhD (8610 88326666, Zhao_xy@bjmu.edu.cn), 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 NCT06209671, 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 17 Jan 2024.