Refractory and Relapsed B Cell Acute LeukemiaPhase 1NCT04508842
CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
A Phase 1 study testing CD19/CD22-Dual-STAR-T in people with Refractory and Relapsed B Cell Acute Leukemia, run by Hebei Yanda Ludaopei Hospital at 1 site in China.
Trial summary
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia . Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Refractory and Relapsed B Cell Acute Leukemia
- What is being tested?
- CD19/CD22-Dual-STAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2020to 1 May 2022
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 1 to 70 years.
- Prelapsed and refractorys B-ALL at least with one of the following conditions:
- Could not achieve CR after 2course of chemotherapy.
- Could not achieve CR or relapse after first-line or multi-line salvage chemotherapy, or MRD≥0.1%.
- Relapse within 12 months after first remission or MRD≥0.1%.
- Relapse after achieved CR in allogeneic hematopoietic stem cell transplantation (HSCT), or MRD≥0.1%.
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- For Ph + patients: Failure to tolerate TKI or TKI treatment failure could be enrolled.
- CD19 and/or CD22 positive within 3 months.
- ECOG 0-2.
- Estimated life expectancy ≥ 3 months.
- Women of childbearing age must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 12 months after discontinuation of treatment during the study period not pregnant inside.
- Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
Who cannot join
- Active infections that are difficult to control
- HBV-DNA HCV-RNA and HIV ,either of which is positive
- Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy
- Patients are receiving anti-GVHD treatment within 4 weeks of before screening.
- Performed major surgery within 4 weeks before screening.
- Patients have received chemotherapy within 7 days of screening.
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- Experimental drugs were used within 4 weeks before screening.
- Received allogeneic cell therapy within 6 weeks prior to cell infusion.
- Patients have history of epilepsy or central nervous system diseases.
- Severe thyroid dysfunction
- Patients with active autoimmune disease.
- Pregnant or lactating women.
- The patient does not agree to use effective contraception during treatment and for the following 12 months;
- The researchers found that it was unsuitable for the recipients to be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .
Read the detailed description
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.The purpose of current study is to evaluate the clinical safety and efficacy of CD19/CD22-Dual-STAR-T cells therapy in patients with refractory and relapsed B-ALL.Safety and efficacy of Dual-STAR-T cells therapy will be monitored. The primary endpoint is the safety of Dual-STAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the Dual-STAR-T cell proliferation ratio and Dual-STAR gene copied number in peripheral blood（PB）， and progression free survival(PFS ), overall-survival(OS) and duration of overall response(DOR).
- Being tested
- CD19/CD22-Dual-STAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/CD22-Dual-STAR-TBiological
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| CD19/CD22-Dual-STAR-T | Experimental | CD19/CD22-Dual-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of Dual-STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 500mg/m2 for 3 days and take a rest for 2 days before infusion. Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg. Receives: Biological: CD19/CD22-Dual-STAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with adverse events.
Percentage of participants with adverse events.
Measured: 12 months
Secondary outcomes (2)
Objective Remission Rate(ORR)
The percentage of participants who achieved complete remission(CR) and CR in over all participants.
Measured: 12 months
Proliferation ratio of Dual-STAR-T cells
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start10 Oct 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Adjustment plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory and Relapsed B Cell Acute 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xian Zhang, PhD, Study director, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508842
- Sponsor's protocol ID
- HXYT-011
- Status last verified
- May 2022
- First submitted
- 9 Aug 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.
- ClinicalTrials.gov ID
- NCT04508842
- Acronym / sponsor ID
- HXYT-011
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment plan
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 11 Aug 2020 (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 single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .
Detailed description
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.The purpose of current study is to evaluate the clinical safety and efficacy of CD19/CD22-Dual-STAR-T cells therapy in patients with refractory and relapsed B-ALL.Safety and efficacy of Dual-STAR-T cells therapy will be monitored. The primary endpoint is the safety of Dual-STAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the Dual-STAR-T cell proliferation ratio and Dual-STAR gene copied number in peripheral blood（PB）， and progression free survival(PFS ), overall-survival(OS) and duration of overall response(DOR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19/CD22-Dual-STAR-T | Experimental | Biological: CD19/CD22-Dual-STAR-TCD19/CD22-Dual-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of Dual-STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 500mg/m2 for 3 days and take a rest for 2 days before infusion. Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Ages 1 to 70 years.
- Prelapsed and refractorys B-ALL at least with one of the following conditions:
- CD19 and/or CD22 positive within 3 months.
- ECOG 0-2.
- Estimated life expectancy ≥ 3 months.
Key exclusion criteria (14 listed)
- Active infections that are difficult to control
- HBV-DNA HCV-RNA and HIV ,either of which is positive
- Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy
- Patients are receiving anti-GVHD treatment within 4 weeks of before screening.
- Performed major surgery within 4 weeks before screening.
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 |
|---|---|---|
| CD19/CD22-Dual-STAR-TPatients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg. | Biological | CD19/CD22-Dual-STAR-T |
Primary outcome
Percentage of participants with adverse events.
Time frame: 12 months
Percentage of participants with adverse events.
2 secondary outcomes
Objective Remission Rate(ORR)
Time frame: 12 months
Proliferation ratio of Dual-STAR-T cells
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Adjustment plan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
Xian Zhang, PhD study director
Hebei Yanda Ludaopei 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 CD19/CD22-Dual-STAR-T in people with Refractory and Relapsed B Cell Acute Leukemia, run by Hebei Yanda Ludaopei Hospital 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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Sep 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?
The study was stopped early (reason given: Adjustment plan). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with adverse events. (time frame: 12 months). 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 28 Sep 2022.