AMLNCT05388305
Universal CAR-γδT Cell Injection in the AML Patients
A study testing CAR--γδT cells in people with AML, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
To evaluate the safety of general-purpose CAR-γδT cells in patients with refractory post-transplant relapsed AML. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AML
- What is being tested?
- CAR--γδT cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 30 May 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The clinical diagnosis was difficult to treat recurrent acute myeloid leukemia；
- Flow cytometry (FCM) or immunohistochemistry of tumor~ cells confirmed positive expression of CD123；
- 18 years old ≤ age ≤70 years old;
- The expected survival from the date of informed consent is more than 3 months;
- ECOG≤2;
- The functions of vital organs shall meet the following conditions:
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- 1) EF>50%, and no obvious ECG abnormality; 2) SpO2 90% or more; 3) Cr 2.5 ULN or less; 4) ALT And AST≤5ULN, TBil≤3ULN;
- Subjects who plan to become pregnant must agree before study enrollment and after study duration of 6 months Use contraception; Inform the investigator immediately if the subject is pregnant or suspected to be pregnant;
- Subject or guardian understands and signs the informed consent.
Who cannot join
- Other diseases that have not been effectively controlled, including but not limited to persistent or poorly controlled infections and diseases Congestive heart failure, unstable angina pectoris, arrhythmias, poorly controlled lung disease Or mental illness;
- Other active malignant tumors;
- Complicated with severe infection that cannot be effectively controlled;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to be eliminated; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA in peripheral blood was positive;
- Human immunodeficiency virus (HIV) infection or syphilis infection;
- Have a history of severe allergy to biological products (including antibiotics);
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- Acute graft-versus-host reaction (GVHD) was still present one month after discontinuation of immunosuppressant therapy Allogeneic hematopoietic stem cell transplantation patients;
- Female subjects are in pregnancy and lactation;
- Active autoimmune diseases requiring systemic immunosuppression;
- Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the test;
Trial locations and contacts
1 site in 1 country.
Liang Huang, PhD contact
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei
Liang Huang, PhD&MD
About this study
Official title: Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Refractory and Relapsed AML Patients
To evaluate the safety of general-purpose CAR-γδT cells in patients with refractory post-transplant relapsed AML.
Read the detailed description
To evaluate the efficacy and in vivo dynamics of general-purpose CAR-γδT cells in the treatment of refractory relapsed AML patients, and to explore the appropriate therapeutic dose and delivery mode.
- Conditions
- AML
- Being tested
- CAR--γδT cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR--γδT cellsBiological
Biological: CAR-γδT; Drug:
| Study group | Role | What they receive |
|---|---|---|
| CAR--γδT | Experimental | Not described Receives: Biological: CAR--γδT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CAR-γδT infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Measured: First 1 month post CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start20 Apr 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 May 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liang Huang, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388305
- Sponsor's protocol ID
- CAR-γδT for AML
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 26 May 2022
- Results posted
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Refractory and Relapsed AML Patients
- ClinicalTrials.gov ID
- NCT05388305
- Acronym / sponsor ID
- CAR-γδT for AML
- Conditions
- AML
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 24 May 2022 (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.
To evaluate the safety of general-purpose CAR-γδT cells in patients with refractory post-transplant relapsed AML.
Detailed description
To evaluate the efficacy and in vivo dynamics of general-purpose CAR-γδT cells in the treatment of refractory relapsed AML patients, and to explore the appropriate therapeutic dose and delivery mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR--γδT | Experimental | Biological: CAR--γδT cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The clinical diagnosis was difficult to treat recurrent acute myeloid leukemia；
- Flow cytometry (FCM) or immunohistochemistry of tumor~ cells confirmed positive expression of CD123；
- 18 years old ≤ age ≤70 years old;
- The expected survival from the date of informed consent is more than 3 months;
- ECOG≤2;
Key exclusion criteria (10 listed)
- Other diseases that have not been effectively controlled, including but not limited to persistent or poorly controlled infections and diseases Congestive heart failure, unstable angina pectoris, arrhythmias, poorly controlled lung disease Or mental illness;
- Other active malignant tumors;
- Complicated with severe infection that cannot be effectively controlled;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to be eliminated; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA in peripheral blood was positive;
- Human immunodeficiency virus (HIV) infection or syphilis 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 |
|---|---|---|
| CAR--γδT cellsBiological: CAR-γδT; Drug: | Biological | CAR--γδT |
Primary outcome
Safety: Incidence and severity of adverse events
Time frame: First 1 month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CAR-γδT infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- 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.
Liang Huang, PhD contact
Liang Huang, PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR--γδT cells in people with AML, run by Hebei Senlang Biotechnology Inc., 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 9 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 26 May 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.
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 Liang Huang, PhD (027-83665555), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and severity of adverse events (time frame: First 1 month post CAR-T cells infusion). 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 26 May 2022.