Therapy Related LeukemiaEarly Phase 1NCT03407859
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL
A Early Phase 1 study testing Sequential Treatment With different CART in people with Therapy Related Leukemia, run by Zhujiang Hospital at 1 site in China.
Trial summary
CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19-negative relapse of B-ALL. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Therapy Related Leukemia
- What is being tested?
- Sequential Treatment With different CART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2016to 31 Mar 2025
- Phase
- Early 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Relapsed/Refractory B-ALL patients
- Did not achieve complete remission after 2 times of standard plan chemotherapy
- Relapsed after first induction chemotherapy
- Did not response to chemotherapy before HSCT or relapsed after HSCT
- Cannot receive allo-HSCT or refuse to receive allo-HSCT
- Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined)
- Estimated survival time is more than 3 months in leukemia
- Volunteered for this clinical trail and signed a consent form
Who cannot join
- MRD was negative while the cell phenotype was CD19 expressed
- Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
- Patients with severe mental illness, neurological disease or infectious disease
- Patients with GVHD was taking immunosuppressants
- Pregnant or lactating women
- Patients have received other genetic therapy products
- Transfection efficiency was less than 30%
- Any situation may do harm to the subjects or interfere the results
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern Medical University Zhujiang Hospital
Guangdong, Guangdong, 510000
Yuhua Li, PhD
About this study
CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.
Read the detailed description
B-cell acute lymphoblastic leukemia is the most common type of leukemia and the prognosis of relapsed/refractory B-ALL is poor. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. CD19 CAR-T is the most commonly used engineered T cell in B-ALL. The treatment effect is significant and far more than traditional therapy in relapsed/refractory B-ALL. However, the remission time after CD19 CAR-T infusion is short.CD19-positive and CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients The cause of relapse after CAR-T infusion is minimal residual disease (MRD) which will induce CD19 negative relapse. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19 negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.
- Conditions
- Therapy Related Leukemia
- Being tested
- Sequential Treatment With different CART
- Keywords
- CD19-CART, CD20-CART, CD10-CART, CD22-CART, Relapsed/Refractory B-ALL, MRD, CD70-CART
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential Treatment With different CARTBiological
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment in Relapsed/Refractory B-ALL
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy with different CART | Experimental | Sequential therapy With different CART including one kind of CD20/CD22/CD10-CART After CD19-CART therapy in CD19-negative relapse ALL patients, subjects will receive 1-5 x 10^6/Kg transduced CAR T cells at one time. Receives: Biological: Sequential Treatment With different CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events that Are related to treatment
Determine the toxicity profile of the CD19-targeted and CD20/CD22/CD10-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Measured: 2 years
Secondary outcomes (3)
Estimate 2 year overall survival(OS) after infusion of CD19-CART and sequential treatment
To estimate 2 year overall survival(OS) after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
Measured: 2 years
Estimate relapse rate after infusion of CD19-CART and sequential treatment
To estimate relapse rate after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
Measured: 4 years
Estimate 2 year progression free survival after infusion of CD19-CART and sequential treatment
To estimate 2 year progression free survival (PFS) after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start18 Jan 2016
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy Related 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Yanjie He, Ph.D, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407859
- Sponsor's protocol ID
- 2016-XYNK-002
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL
- ClinicalTrials.gov ID
- NCT03407859
- Acronym / sponsor ID
- 2016-XYNK-002
- Conditions
- Therapy Related Leukemia
- Keywords
- CD19-CART, CD20-CART, CD10-CART, CD22-CART, Relapsed/Refractory B-ALL, MRD, CD70-CART
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Jan 2018 (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.
CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.
Detailed description
B-cell acute lymphoblastic leukemia is the most common type of leukemia and the prognosis of relapsed/refractory B-ALL is poor. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. CD19 CAR-T is the most commonly used engineered T cell in B-ALL. The treatment effect is significant and far more than traditional therapy in relapsed/refractory B-ALL. However, the remission time after CD19 CAR-T infusion is short.CD19-positive and CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients The cause of relapse after CAR-T infusion is minimal residual disease (MRD) which will induce CD19 negative relapse. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19 negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy with different CART | Experimental | Biological: Sequential Treatment With different CARTSequential therapy With different CART including one kind of CD20/CD22/CD10-CART After CD19-CART therapy in CD19-negative relapse ALL patients, subjects will receive 1-5 x 10^6/Kg transduced CAR T cells at one time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Relapsed/Refractory B-ALL patients
- Did not achieve complete remission after 2 times of standard plan chemotherapy
- Relapsed after first induction chemotherapy
- Did not response to chemotherapy before HSCT or relapsed after HSCT
- Cannot receive allo-HSCT or refuse to receive allo-HSCT
Key exclusion criteria (8 listed)
- MRD was negative while the cell phenotype was CD19 expressed
- Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
- Patients with severe mental illness, neurological disease or infectious disease
- Patients with GVHD was taking immunosuppressants
- Pregnant or lactating women
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 |
|---|---|---|
| Sequential Treatment With different CARTSequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment in Relapsed/Refractory B-ALL | Biological | Sequential therapy with different CART |
Primary outcome
Adverse events that Are related to treatment
Time frame: 2 years
Determine the toxicity profile of the CD19-targeted and CD20/CD22/CD10-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
3 secondary outcomes
Estimate 2 year overall survival(OS) after infusion of CD19-CART and sequential treatment
Time frame: 2 years
Estimate relapse rate after infusion of CD19-CART and sequential treatment
Time frame: 4 years
Estimate 2 year progression free survival after infusion of CD19-CART and sequential treatment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
Yanjie He, Ph.D principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sequential Treatment With different CART in people with Therapy Related Leukemia, run by Zhujiang 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 8 inclusion and 8 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 15 Mar 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Yuhua Li, Ph.D (86-20-61643188, liyuhua2011gz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events that Are related to treatment (time frame: 2 years). 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 15 Mar 2024.