AMLPhase 1NCT04766840
Donor-derived CAR-T Cells in the Treatment of AML Patients
A Phase 1 study testing CAR-T cells in people with AML, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
This is a clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- What is being tested?
- CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory or relapsed AML patients.
- Have found an appropriate matched donor for CAR-T cells manufacturing.
- Patients must have evaluable evidence of disease.
- Age ≥ 18 years; Expected survival is more than 3 months.
- ECOG score 0-2 points.
- Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up.
- Adequet liver, kidney, heart and lung function.
Who cannot join
- Confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia.
- Patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases.
- Prior use of any gene therapy product.
- History of epilepsy or other central nervous system diseases.
- Presence of concurrent active malignancy.
- Active hepatitis B or C virus, patients with HIV or syphilis infection.
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- Currently participating in or having participated in other drug clinical trials during past 30 days.
- Active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment.
- Other situations not suitable for the study judged by the investigator.
Trial locations and contacts
1 site in 1 country.
Xiaojun Huang, MD contact
About this study
Official title: A Study to Evaluate the Safety and Efficacy of Donor-derived CAR-T Cells in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
This is a clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China.
Read the detailed description
This is a single-center, single-arm, open-label study. This study is planned to enroll about 9 subjects with relapsed or refractory acute myelogenous leukemia and 9 matched donors for leukapheresis and CAR-T cells manufacture. Donor-derived CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.
- Conditions
- AML
- Being tested
- CAR-T cells
- Keywords
- CAR-T, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cellsDrug
Also called IM73 CAR-T Cells
Drug: IM73 CAR-T Cells Drug: Fludarabine Two days before cell infusion, patient will be treated with fludarabine for 3 days Drug: Cyclophosphamide: Two days before cell infusion, patient will be treated with Cyclophosphamide for 3 days
| Study group | Role | What they receive |
|---|---|---|
| IM73 CAR-T | Experimental | Drug: IM73 CAR-T Cells
* Fludarabine
* Cyclophosphamide Receives: Drug: CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
≥ Grade 4 adverse event related to CAR-T cells infusion
Measured: 28 days
Secondary outcomes (1)
Objective response rate
Patients who achieve CR（complete response） or CRi 28 days after CAR-T cells infusuion
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojun Huang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766840
- Sponsor's protocol ID
- YMCART202005
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Donor-derived CAR-T Cells in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04766840
- Acronym / sponsor ID
- YMCART202005
- Conditions
- AML
- Keywords
- CAR-T, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Feb 2021 (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 clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China.
Detailed description
This is a single-center, single-arm, open-label study. This study is planned to enroll about 9 subjects with relapsed or refractory acute myelogenous leukemia and 9 matched donors for leukapheresis and CAR-T cells manufacture. Donor-derived CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM73 CAR-T | Experimental | Drug: CAR-T cellsDrug: IM73 CAR-T Cells * Fludarabine * Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Refractory or relapsed AML patients.
- Have found an appropriate matched donor for CAR-T cells manufacturing.
- Patients must have evaluable evidence of disease.
- Age ≥ 18 years; Expected survival is more than 3 months.
- ECOG score 0-2 points.
Key exclusion criteria (9 listed)
- Confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia.
- Patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases.
- Prior use of any gene therapy product.
- History of epilepsy or other central nervous system diseases.
- Presence of concurrent active malignancy.
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 |
|---|---|---|
| CAR-T cellsAlso: IM73 CAR-T CellsDrug: IM73 CAR-T Cells Drug: Fludarabine Two days before cell infusion, patient will be treated with fludarabine for 3 days Drug: Cyclophosphamide: Two days before cell infusion, patient will be treated with Cyclophosphamide for 3 days | Drug | IM73 CAR-T |
Primary outcome
Dose limiting toxicity
Time frame: 28 days
≥ Grade 4 adverse event related to CAR-T cells infusion
1 secondary outcome
Objective response rate
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- 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.
Xiaojun Huang, MD contact
Xiaojun Huang, MD principal investigator
Peking University People's 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 CAR-T cells in people with AML, run by Beijing Immunochina Medical Science & Technology 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 7 inclusion and 9 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 23 Feb 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 FEI Wu (15801390058, wufei@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: 28 days). 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 23 Feb 2021.