Acute Lymphoblastic LeukemiaPhase 1NCT05223686
To Evaluate the Safety and Tolerability of Human CD19-CD22 Targeted T Cells Injection for Subjects With R/R B-ALL.
A Phase 1 study testing Human CD19-CD22 Targeted T Cells Injection in people with Acute Lymphoblastic Leukemia, run by Hrain Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of Human CD19-CD22 Targeted T Cells Injection for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19-CD22 CAR+ T cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Human CD19-CD22 Targeted T Cells Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 10 Mar 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia:
- 18~70 years old (including cut-off value), male and female;
- Expected survival > 12 weeks;
- ECOG score 0-1;
- Bone marrow examination clearly diagnosed as B-cell acute lymphoblastic leukemia , CD19 or/and CD22 positive , and who met one of the following conditions:
- Those who failed to achieve CR after at least 2 courses of standard chemotherapy or had early relapse after complete remission (<12 months) or late relapse after complete remission (≥ 12 months) and failed to achieve CR after 1 course of standard chemotherapy;
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- For Ph+ ALL: in addition to receiving at least 2 courses of standard chemotherapy, at least two TKIs should be treated with no complete remission or relapse after complete remission; (Patients who cannot tolerate TKI therapy or have TKI treatment contraindications or have T315i mutation are excluded);
- Those who relapse after stem cell transplantation are not affected by previous treatments;
- The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Serum creatinine≤1.5×ULN;
- Left ventricular ejection fraction>50%;
- Baseline blood oxygen saturation>96%;
- Total bilirubin≤2×ULN; ALT and AST≤3×ULN (As judged by the investigator, the elevation of transaminase caused by the ALL disease itself, ALT and AST≤5×ULN);
- Able to understand and sign the Informed Consent Document.
Who cannot join
- Any one of the following conditions cannot be selected as a subject：
- Graft-versus-host disease (GVHD), or need to use immunosuppressants after transplantation;
- Patients with hyperleukocytosis (white blood cell count ≥50×10^9/L) or whose disease progressed rapidly according to the investigator's judgment at the time of enrollment and cannot ensure the completion of a complete treatment cycle;
- Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;
- Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection higher than the lower limit of the research center can detect; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive;
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
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- Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
- Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
- Received CAR-T treatment or other gene therapies before enrollment;
- Patients with symptoms of central nervous system;
- Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use);
- The investigators consider other conditions unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jianqing Mi, Doctor, +8613524488296, jianqingmi@shsmu.edu.cn
About this study
Official title: A Phase I Clinical Study To Evaluate the Safety and Tolerability of Human CD19-CD22 Targeted T Cells Injection for In Subjects With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia.
To evaluate the safety and tolerability of Human CD19-CD22 Targeted T Cells Injection for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19-CD22 CAR+ T cells.
Read the detailed description
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of Human CD19-CD22 Targeted T Cells Injection. To preliminary observe the effect of Human CD19-CD22 Targeted T Cells Injection in relapsed/refractory B-cell acute lymphoblastic leukemia, and to explore the clinically applicable dose and reinfusion regimen for phase II.
Participants with relapsed/refractory B-cell Acute Lymphoblastic Leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, Computedtomography （CT）/ Magnetic Resonance Imaging(MRI) / Positron Emission Tomography（PET）, and blood draws. Participants receive chemotherapy prior to the infusion of CD19-CD22 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19-CD22 CAR+ T cells. Study procedures may be performed while hospitalized.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Human CD19-CD22 Targeted T Cells Injection
- Keywords
- Acute Lymphoblastic Leukemia, CD19-CD22, CAR-T, relapsed/refractory
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human CD19-CD22 Targeted T Cells InjectionDrug
Also called CD19-CD22 CAR-T
One time single predetermined dose level CAR-positive T cells will be utilized based on the NMPA approved product label.
| Study group | Role | What they receive |
|---|---|---|
| Human CD19-CD22 Targeted T Cells Injection | Experimental | Single administration：1.0×10^6 CAR+T, 3.0×10^6 CAR+T，6.0×10^6 CAR+T Receives: Drug: Human CD19-CD22 Targeted T Cells Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity(DLT)
Safety indicators
Measured: 28 days post infusion
Secondary outcomes (11)
Adverse events；
Safety indicators
Measured: 28 days post infusion
Pharmacokinetic parameters: the highest concentration of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacokinetic parameters: the time to reach the highest concentration of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacokinetic parameters: the 28-day area under the curve of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacodynamic parameters: the detection counts of CD19 or CD22 positive B cells in peripheral blood;
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacodynamicparameters: the detection values of IL-6, CRP, and IL-15 cytokines in peripheral blood;
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Overall response rate (ORR) after administration
Effectiveness Metrics
Measured: 3 months post infusion
Duration of remission (DOR) after administration
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Progress Free Survival (PFS) after administration
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Overall Survival (OS) after administration
Effectiveness Metrics
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
The immunogenicity of Human CD19-CD22 Targeted T Cells Injection. (the detection of human anti-mouse antibody)
Safety indicators
Measured: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start10 Feb 2022 (estimated)
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hrain Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
- Investigators
- Jianqing Mi, Doctor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223686
- Sponsor's protocol ID
- HRAIN01-ALL02
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 4 Feb 2022
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study To Evaluate the Safety and Tolerability of Human CD19-CD22 Targeted T Cells Injection for In Subjects With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia.
- ClinicalTrials.gov ID
- NCT05223686
- Acronym / sponsor ID
- HRAIN01-ALL02
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, CD19-CD22, CAR-T, relapsed/refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hrain Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Study start
- 10 Feb 2022 (estimated)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 4 Feb 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.
To evaluate the safety and tolerability of Human CD19-CD22 Targeted T Cells Injection for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19-CD22 CAR+ T cells.
Detailed description
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of Human CD19-CD22 Targeted T Cells Injection. To preliminary observe the effect of Human CD19-CD22 Targeted T Cells Injection in relapsed/refractory B-cell acute lymphoblastic leukemia, and to explore the clinically applicable dose and reinfusion regimen for phase II.
Participants with relapsed/refractory B-cell Acute Lymphoblastic Leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, Computedtomography （CT）/ Magnetic Resonance Imaging(MRI) / Positron Emission Tomography（PET）, and blood draws. Participants receive chemotherapy prior to the infusion of CD19-CD22 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19-CD22 CAR+ T cells. Study procedures may be performed while hospitalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human CD19-CD22 Targeted T Cells Injection | Experimental | Drug: Human CD19-CD22 Targeted T Cells InjectionSingle administration：1.0×10^6 CAR+T, 3.0×10^6 CAR+T，6.0×10^6 CAR+T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18~70 years old (including cut-off value), male and female;
- Expected survival > 12 weeks;
- ECOG score 0-1;
- Bone marrow examination clearly diagnosed as B-cell acute lymphoblastic leukemia , CD19 or/and CD22 positive , and who met one of the following conditions:
- The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
Key exclusion criteria (12 listed)
- Any one of the following conditions cannot be selected as a subject：
- Graft-versus-host disease (GVHD), or need to use immunosuppressants after transplantation;
- Patients with hyperleukocytosis (white blood cell count ≥50×10^9/L) or whose disease progressed rapidly according to the investigator's judgment at the time of enrollment and cannot ensure the completion of a complete treatment cycle;
- Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;
- Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection higher than the lower limit of the research center can detect; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive;
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 |
|---|---|---|
| Human CD19-CD22 Targeted T Cells InjectionAlso: CD19-CD22 CAR-TOne time single predetermined dose level CAR-positive T cells will be utilized based on the NMPA approved product label. | Drug | Human CD19-CD22 Targeted T Cells Injection |
Primary outcome
Dose limited toxicity(DLT)
Time frame: 28 days post infusion
Safety indicators
11 secondary outcomes
Adverse events；
Time frame: 28 days post infusion
Pharmacokinetic parameters: the highest concentration of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacokinetic parameters: the time to reach the highest concentration of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacokinetic parameters: the 28-day area under the curve of anti-human CD19-CD22 T cells amplified in peripheral blood after reinfusion;
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacodynamic parameters: the detection counts of CD19 or CD22 positive B cells in peripheral blood;
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Pharmacodynamicparameters: the detection values of IL-6, CRP, and IL-15 cytokines in peripheral blood;
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Overall response rate (ORR) after administration
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Progress Free Survival (PFS) after administration
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Overall Survival (OS) after administration
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
The immunogenicity of Human CD19-CD22 Targeted T Cells Injection. (the detection of human anti-mouse antibody)
Time frame: 2 years post infusion（the last subject will be followed up to 15 years after infusion）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- 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.
Jianqing Mi, Doctor principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human CD19-CD22 Targeted T Cells Injection in people with Acute Lymphoblastic Leukemia, run by Hrain Biotechnology 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 15 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 4 Feb 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?
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 Xuedong Sun, Doctor (+8615811287219, sunxuedong@dashengbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity(DLT) (time frame: 28 days post infusion). 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 4 Feb 2022.