CD19-positivePhase 1NCT03798509
Human CD19 Targeted T Cells Injection Therapy for Relapsed and Refractory CD19-positive Leukemia
A Phase 1 study testing Human CD19 targeted T Cells Injection in people with CD19-positive and Acute Lymphoblastic Leukemia, run by Hrain Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CD19-positive, Acute Lymphoblastic Leukemia
- What is being tested?
- Human CD19 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
- 13 Mar 2019to Jan 2024
- 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
- 18 to 70 Years Old, Male and female;
- Expected survival > 12 weeks;
- ECOG score 0-1;
- Bone marrow examination clearly diagnosed as CD19 positive B-cell acute lymphoblastic leukemia 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;
- 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);
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- 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:
- Creatinine is in the normal range;
- Left ventricular ejection fraction >50%;
- Baseline oxygen saturation>92%;
- Total bilirubin ≤ 2×ULN; ALT and AST ≤2.5 × ULN;
- Able to understand and sign the Informed Consent Document.
Who cannot join
- Graft-versus-host disease (GVHD), or need to use immunosuppressants;
- 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, and ductal carcinoma in situ after radical resection;
- Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA 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;
- 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;
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- 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); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
- The investigators consider other conditions unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Xianmin Song, Professor, 021-63240090 ext. 3173, shongxm@139.com
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia
To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Read the detailed description
Participants with relapsed/refractory CD19-positive 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 and blood draws. Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.
- Conditions
- CD19-positive, Acute Lymphoblastic Leukemia
- Being tested
- Human CD19 targeted T Cells Injection
- Keywords
- CD19, CAR-T, leukemia, Relapsed /Refractory, B-ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human CD19 targeted T Cells InjectionDrug
Autologous genetically modified anti-CD19 CAR transduced T cells
| Study group | Role | What they receive |
|---|---|---|
| Human CD19 targeted T Cells Injection | Experimental | Not described Receives: Drug: Human CD19 targeted T Cells Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Measured: 28 days post infusion
Secondary outcomes (7)
Duration of CAR-positive T cells in circulation
Measured: 2 years post infusion
The concentration of CD19-positive B cells in peripheral blood.
Measured: 2 years post infusion
Overall response rate (ORR) after administration
Measured: 90 days post infusion
Duration of remission (DOR) after administration
Measured: 2 years post infusion
Progress Free Survival (PFS) after administration
Measured: 2 years post infusion
Overall Survival (OS)after administration
Measured: 2 years post infusion
The immunogenicity of Human CD19 targeted T Cells Injection. (the detection of human anti-mouse antibody)
Measured: 2 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start13 Mar 2019
- Primary completionJan 2022 (estimated)
- Study completionJan 2024 (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 CD19-positiveStudies 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
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798509
- Sponsor's protocol ID
- HRAIN01-ALL01
- Status last verified
- Aug 2021
- First submitted
- 3 Jan 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6.
PubMed 36536403
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03798509
- Acronym / sponsor ID
- HRAIN01-ALL01
- Conditions
- CD19-positive, Acute Lymphoblastic Leukemia
- Keywords
- CD19, CAR-T, leukemia, Relapsed /Refractory, B-ALL
- 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
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 10 Jan 2019 (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 tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Detailed description
Participants with relapsed/refractory CD19-positive 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 and blood draws. Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 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 targeted T Cells Injection | Experimental | Drug: Human CD19 targeted T Cells Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 to 70 Years Old, Male and female;
- Expected survival > 12 weeks;
- ECOG score 0-1;
- Bone marrow examination clearly diagnosed as CD19 positive B-cell acute lymphoblastic leukemia 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 (10 listed)
- Graft-versus-host disease (GVHD), or need to use immunosuppressants;
- 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, and ductal carcinoma in situ after radical resection;
- Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA 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;
- Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
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 targeted T Cells InjectionAutologous genetically modified anti-CD19 CAR transduced T cells | Drug | Human CD19 targeted T Cells Injection |
Primary outcome
DLT
Time frame: 28 days post infusion
7 secondary outcomes
Duration of CAR-positive T cells in circulation
Time frame: 2 years post infusion
The concentration of CD19-positive B cells in peripheral blood.
Time frame: 2 years post infusion
Overall response rate (ORR) after administration
Time frame: 90 days post infusion
Duration of remission (DOR) after administration
Time frame: 2 years post infusion
Progress Free Survival (PFS) after administration
Time frame: 2 years post infusion
Overall Survival (OS)after administration
Time frame: 2 years post infusion
The immunogenicity of Human CD19 targeted T Cells Injection. (the detection of human anti-mouse antibody)
Time frame: 2 years post infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 36536403Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6.
- 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.
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 targeted T Cells Injection in people with CD19-positive and 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 14 inclusion and 10 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 31 Aug 2021. 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 Hongliang Fang, doctor (021-58552006, fanghongliang@dashengbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
On the ClinicalTrials.gov record for NCT03798509, 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 31 Aug 2021.