Leukemia, Acute Lymphocytic (ALL)Phase 1NCT03291444
CAR-T Cells Combined With Peptide Specific Dendritic Cell in Relapsed/Refractory Leukemia/MDS
A Phase 1 study testing Chimeric antigen receptor T cells and peptide specific dendritic cell in people with Leukemia, Acute Lymphocytic (ALL) and Leukemia, Acute Myelogenous (AML), run by Zhujiang Hospital at 1 site in China.
Trial summary
The main purpose of this study is to verify the safety and potential effectiveness of CART cells combined with peptide specific dendritic cell in relapsed/refractory leukemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leukemia, Acute Lymphocytic (ALL), Leukemia, Acute Myelogenous (AML), Myelodysplastic Syndromes
- What is being tested?
- Chimeric antigen receptor T cells and peptide specific dendritic cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2018to 1 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor type: Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) according to the WHO criteria (at least 20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
- Positive antigen for any of CD19, CD20, CD22, CD10, CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.Simultaneously ,high expression of EPS8 or WT1 in acute leukemia.
- Relapsed/Refractory leukemia 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.
Show all 19Show fewer
- Cannot receive allo-HSCT or refuse to receive allo-HSCT.
- Relapsed after CAR-T cell infusion.
- Age greater than 18 year and less than 80 years.
- Objectively assessable parameters of life expectancy: more than 3 months.
- Performance status: WHO PS grade 0-1 (ECOG performance status 0 or 1).
- Meet the following criteria for apheresis：WBC >= 3,000/L, Hb >= 8.0 g/dL, platelet count >= 80,000/mm3, <= 600,000/mm3.
- Pulmonary function: Peripheral blood oxygen saturation greater than 90%; Cardiac function: Left ventricular ejection fraction >60%.
- Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV.
- No concomitant use of immunosuppressive drugs.
- Adequate renal and liver function, i.e. creatinin, bilirubin, and aminotransferase =< 1.2 times the upper limit of normal.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation.
- Written informed consent obtained.
Who cannot join
- Patients with severe complications: cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases, sever allergy and severe infectious disease.
- Patients who should receive systemic administration of steroid or immunosuppressive agents.
- Presence of active brain metastases.
- Pregnant, lactating, or possibly pregnant women, or willing to be pregnant.
- Severe psychiatric disorder.
- Active multiple cancers.
Show all 10Show fewer
- Patients have received other genetic therapy products.
- Transfection efficiency was less than 30%.
- Inappropriate for study entry judged by an attending physician.
- patients who have sensitivity to drugs that provide local anesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510282
Sanfang Tu, M.D, Ph.D, 86-20-62782322, doctortutu@163.com
Yanjie He, M.D, Ph.D, 86-20-61643190, hyjgzh2006@163.com
About this study
Official title: A Clinical Study of Chimeric Antigen Receptor T Cells Combined With Eps8 Peptide Specific Dendritic Cell for Patients With Relapsed/Refractory Leukemia and Myelodysplastic Syndromes
The main purpose of this study is to verify the safety and potential effectiveness of CART cells combined with peptide specific dendritic cell in relapsed/refractory leukemia.
Read the detailed description
A prospective study to evaluate the safety and efficacy of Chimeric antigen receptor T cells combined with Eps8 or WT1（Wilms tumor 1） peptide specific dendritic cell for patients with relapsed/refractory leukemia. There are options for CAR-targets: CD19, CD20, CD22 and CD10 for acute lymphoblastic leukemia; CD33, CD38 CD56, CD117, CD123, CD34 and Muc1 for acute myeloid leukemia and Myelodysplastic Syndrome. Progression free survival, overall Survival, overall response rate, and duration of response were monitored.
- Conditions
- Leukemia, Acute Lymphocytic (ALL), Leukemia, Acute Myelogenous (AML), Myelodysplastic Syndromes
- Being tested
- Chimeric antigen receptor T cells, peptide specific dendritic cell
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric antigen receptor T cellsBiological
Also called CAR-T
After pretreatment, chimeric antigen receptor T cells will be transfused.
peptide specific dendritic cellBiological
Also called WT1 peptide specific dendritic cell, Eps8 peptide specific dendritic cell
After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells combined with peptide specific dendritic cell | Experimental | CAR-T cells combined with Eps8 peptide specific dendritic cell,or CAR-T cells combined with WT1 peptide specific dendritic cell Receives: Biological: Chimeric antigen receptor T cells; Biological: peptide specific dendritic cell |
| Chimeric antigen receptor T cells | Active comparator | After pretreatment, chimeric antigen receptor T cells will be transfused. Receives: Biological: Chimeric antigen receptor T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of study related adverse events, according to NCI CTCAE Version 4.0
Incidence and severity of cytokine release syndrome(CRS): The systemic inflammatory response in patients with significantly increased IL-6 and other cytokines during the observation period is defined as CRS, which is divided into 1-5 grades, 1-2 Grade is mild, grade 3-5 is severe
Measured: up to 12 months
Secondary outcomes (4)
Progression free survival time
Time from random to the first occurrence of disease progression.
Measured: 2 years
Overall survival time
Time from randomization to death due to any cause
Measured: 2 years
Overall response rate
The proportion of the total number of patients with complete remission and partial remission (CR+PR) after treatment in the total number of evaluable cases
Measured: 2 years
Duration of response
During the observation period, the time between complete remission of bone marrow (the ratio of bone marrow blast cells is less than 5%) to the recurrence of bone marrow (the ratio of bone marrow blast cells is greater than 5%) is the continuous remission time.
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 posted25 Sep 2017
- Study start5 May 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (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, Acute Lymphocytic (ALL)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Geno-Immune Medical Institute, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Yuhua Li, M.D, Ph.D, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291444
- Sponsor's protocol ID
- 2017-XYNK-001
- Status last verified
- Mar 2024
- First submitted
- 20 Sep 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
Publications
Tu S, Zhou L, Huang R, Zhou X, Yang J, He Y, Hu Y, Zhang H, Xie X, Li Y. Dendritic cell vaccines extend CAR T-cell persistence and improve the efficacy of CD19 CAR T-cell therapy in refractory or relapsed adult B-ALL patients. Am J Hematol. 2024 Jul;99(7):1437-1440. doi: 10.1002/ajh.27349. Epub 2024 May 7. No abstract available.
PubMed 38712616
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
- A Clinical Study of Chimeric Antigen Receptor T Cells Combined With Eps8 Peptide Specific Dendritic Cell for Patients With Relapsed/Refractory Leukemia and Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT03291444
- Acronym / sponsor ID
- 2017-XYNK-001
- Conditions
- Leukemia, Acute Lymphocytic (ALL), Leukemia, Acute Myelogenous (AML), Myelodysplastic Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Geno-Immune Medical Institute, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 5 May 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 Sep 2017 (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.
The main purpose of this study is to verify the safety and potential effectiveness of CART cells combined with peptide specific dendritic cell in relapsed/refractory leukemia.
Detailed description
A prospective study to evaluate the safety and efficacy of Chimeric antigen receptor T cells combined with Eps8 or WT1（Wilms tumor 1） peptide specific dendritic cell for patients with relapsed/refractory leukemia. There are options for CAR-targets: CD19, CD20, CD22 and CD10 for acute lymphoblastic leukemia; CD33, CD38 CD56, CD117, CD123, CD34 and Muc1 for acute myeloid leukemia and Myelodysplastic Syndrome. Progression free survival, overall Survival, overall response rate, and duration of response were monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAR-T cells combined with peptide specific dendritic cell | Experimental | Biological: Chimeric antigen receptor T cells, Biological: peptide specific dendritic cellCAR-T cells combined with Eps8 peptide specific dendritic cell,or CAR-T cells combined with WT1 peptide specific dendritic cell |
| Chimeric antigen receptor T cells | Active comparator | Biological: Chimeric antigen receptor T cellsAfter pretreatment, chimeric antigen receptor T cells will be transfused. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Tumor type: Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) according to the WHO criteria (at least 20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
- Positive antigen for any of CD19, CD20, CD22, CD10, CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.Simultaneously ,high expression of EPS8 or WT1 in acute leukemia.
- Relapsed/Refractory leukemia patients：
- Age greater than 18 year and less than 80 years.
- Objectively assessable parameters of life expectancy: more than 3 months.
Key exclusion criteria (10 listed)
- Patients with severe complications: cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases, sever allergy and severe infectious disease.
- Patients who should receive systemic administration of steroid or immunosuppressive agents.
- Presence of active brain metastases.
- Pregnant, lactating, or possibly pregnant women, or willing to be pregnant.
- Severe psychiatric disorder.
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 |
|---|---|---|
| Chimeric antigen receptor T cellsAlso: CAR-TAfter pretreatment, chimeric antigen receptor T cells will be transfused. | Biological | CAR-T cells combined with peptide specific dendritic cell, Chimeric antigen receptor T cells |
| peptide specific dendritic cellAlso: WT1 peptide specific dendritic cell, Eps8 peptide specific dendritic cellAfter transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected. | Biological | CAR-T cells combined with peptide specific dendritic cell |
Primary outcome
Occurrence of study related adverse events, according to NCI CTCAE Version 4.0
Time frame: up to 12 months
Incidence and severity of cytokine release syndrome(CRS): The systemic inflammatory response in patients with significantly increased IL-6 and other cytokines during the observation period is defined as CRS, which is divided into 1-5 grades, 1-2 Grade is mild, grade 3-5 is severe
4 secondary outcomes
Progression free survival time
Time frame: 2 years
Overall survival time
Time frame: 2 years
Overall response rate
Time frame: 2 years
Duration of response
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.
- Derived from this study: PubMed 38712616Tu S, Zhou L, Huang R, Zhou X, Yang J, He Y, Hu Y, Zhang H, Xie X, Li Y. Dendritic cell vaccines extend CAR T-cell persistence and improve the efficacy of CD19 CAR T-cell therapy in refractory or relapsed adult B-ALL patients. Am J Hematol. 2024 Jul;99(7):1437-1440. doi: 10.1002/ajh.27349. Epub 2024 May 7. No abstract available.
- 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.
Yuhua Li, M.D, 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 Phase 1 study testing Chimeric antigen receptor T cells and peptide specific dendritic cell in people with Leukemia, Acute Lymphocytic (ALL) and Leukemia, Acute Myelogenous (AML), 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 19 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 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?
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 Sanfang Tu, M.D, Ph.D (86-20-62782322, doctortutu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of study related adverse events, according to NCI CTCAE Version 4.0 (time frame: up to 12 months). 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 NCT03291444, 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 15 Mar 2024.