Acute Myeloid LeukemiaPhase 1/2NCT04351022
CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing CART-38 in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- CART-38
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 Dec 2023
- Phase
- Phase 1/2
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CD38 positive relapsed/refractory acute myeloid leukemia
- age 6-65 years.
- left ventricular ejection fractions ≥ 0.5 by echocardiography
- creatinine < 1.6 mg/dL
- aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal
- Total bilirubin <2.0 mg/dL
- karnofsky performance status ≥ 60
- expected survival time ≥ 3 months (according to investigator's judgement)
Who cannot join
- patients are pregnant or lactating
- uncontrolled active infection
- class III/IV cardiovascular disability according to the New York Heart Association Classification
- active hepatitis B or hepatitis C infection
- patients with HIV infection
- patients with history of seizure
- active central nervous system leukemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Xiaowen Tang, Ph.D, (0086) 51267781856, xwtang1020@163.com
About this study
Official title: Pilot Study of the Efficacy and Safety of CD38 Targeted Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CD38 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.
Read the detailed description
The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- CART-38
- Keywords
- CD38, CART, AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-38Biological
Split intravenous infusion of CART-38 cells [dose escalating infusion of (5-20)x10^6 CART-38 cells/kg].
| Study group | Role | What they receive |
|---|---|---|
| CD38 positive relapsed or refractory acute myeloid leukemia | Experimental | Not described Receives: Biological: CART-38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0
Measured: 12 months
Secondary outcomes (3)
Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Measured: 2 years
Event-free survival (EFS)
time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause.
Measured: 2 years
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse.
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 posted17 Apr 2020
- Study start1 Jul 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, Ph.D, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351022
- Sponsor's protocol ID
- UnicarTherapy2020001
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui Q, Liang P, Dai H, Cui W, Cai M, Ding Z, Ma Q, Yin J, Li Z, Liu S, Kang L, Yao L, Cen J, Shen H, Zhu M, Yu L, Wu D, Tang X. Case report: CD38-directed CAR-T cell therapy: A novel immunotherapy targeting CD38- positive blasts overcomes TKI and chemotherapy resistance of myeloid chronic myeloid leukemia in blastic phase. Front Immunol. 2022 Nov 29;13:1012981. doi: 10.3389/fimmu.2022.1012981. eCollection 2022.
PubMed 36524116Cui Q, Qian C, Xu N, Kang L, Dai H, Cui W, Song B, Yin J, Li Z, Zhu X, Qu C, Liu T, Shen W, Zhu M, Yu L, Wu D, Tang X. CD38-directed CAR-T cell therapy: a novel immunotherapy strategy for relapsed acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation. J Hematol Oncol. 2021 May 25;14(1):82. doi: 10.1186/s13045-021-01092-4.
PubMed 34034795
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Efficacy and Safety of CD38 Targeted Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CD38 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT04351022
- Acronym / sponsor ID
- UnicarTherapy2020001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- CD38, CART, AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Apr 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, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.
Detailed description
The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD38 positive relapsed or refractory acute myeloid leukemia | Experimental | Biological: CART-38 |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- CD38 positive relapsed/refractory acute myeloid leukemia
- age 6-65 years.
- left ventricular ejection fractions ≥ 0.5 by echocardiography
- creatinine < 1.6 mg/dL
- aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal
Key exclusion criteria (7 listed)
- patients are pregnant or lactating
- uncontrolled active infection
- class III/IV cardiovascular disability according to the New York Heart Association Classification
- active hepatitis B or hepatitis C infection
- patients with HIV infection
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 |
|---|---|---|
| CART-38Split intravenous infusion of CART-38 cells [dose escalating infusion of (5-20)x10^6 CART-38 cells/kg]. | Biological | CD38 positive relapsed or refractory acute myeloid leukemia |
Primary outcome
Number of Adverse Events
Time frame: 12 months
Adverse events are evaluated with CTCAE V5.0
3 secondary outcomes
Overall response rate (ORR)
Time frame: 2 years
Event-free survival (EFS)
Time frame: 2 years
Cumulative incidence of relapse(CIR)
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 24 Apr 2020.
- Derived from this study: PubMed 36524116Cui Q, Liang P, Dai H, Cui W, Cai M, Ding Z, Ma Q, Yin J, Li Z, Liu S, Kang L, Yao L, Cen J, Shen H, Zhu M, Yu L, Wu D, Tang X. Case report: CD38-directed CAR-T cell therapy: A novel immunotherapy targeting CD38- positive blasts overcomes TKI and chemotherapy resistance of myeloid chronic myeloid leukemia in blastic phase. Front Immunol. 2022 Nov 29;13:1012981. doi: 10.3389/fimmu.2022.1012981. eCollection 2022.
- Derived from this study: PubMed 34034795Cui Q, Qian C, Xu N, Kang L, Dai H, Cui W, Song B, Yin J, Li Z, Zhu X, Qu C, Liu T, Shen W, Zhu M, Yu L, Wu D, Tang X. CD38-directed CAR-T cell therapy: a novel immunotherapy strategy for relapsed acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation. J Hematol Oncol. 2021 May 25;14(1):82. doi: 10.1186/s13045-021-01092-4.
- 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.
Xiaowen Tang, Ph.D principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CART-38 in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University 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 7 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 24 Apr 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaowen Tang, Ph.D ((0086)51267781856, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 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?
On the ClinicalTrials.gov record for NCT04351022, which also lists 2 linked publications.
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 24 Apr 2020; AzTrials last refreshed its copy on 2 Nov 2026.