Acute-LeukemiaPhase 1/2NCT06585345
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia
A Phase 1/2 study testing CD7 CAR-T cell in people with Acute-Leukemia, run by The General Hospital of Western Theater Command at 1 site in China.
Trial summary
Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Acute-Leukemia
- What is being tested?
- CD7 CAR-T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to 1 Nov 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with acute leukemia.
- Acute leukemia complex/refractory cases with poor response to conventional chemotherapy: 1) patients who did not achieve complete remission after 2 courses of treatment with standard induced remission regimen; 2) Recurrence within 6 months after the first remission; 3) Relapse 6 months after the first remission, but failure to be treated again with the original induced remission regimen; 4) Recurrent patients.
- At least 2 weeks or 5 half-lives (whichever is shorter) from the start of preconditioning chemotherapy after prior systemic treatment, except for immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitor/agonist treatment is at least 3 half-lives away from pre-treatment chemotherapy (e.g., ipilimumab, etc.).
- Toxic reactions caused by previous antitumor therapy must be stabilized and returned to ≤ grade 1 (except for clinically insignificant toxicity, such as baldness).
- Over 14 years old, under 65 years old.
- Physical Strength score 0-3 (ECOG standard)
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- No obvious active infection or graft-versus-host disease
- Expected survival ≥3 months
- Adequate kidney, liver, lung and heart function, defined as:
- Creatinine clearance (estimated by Cockcroft Gault formula) > 60 mL/min; Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤1.5 ULN, excluding subjects with Gilbert's syndrome; Cardiac ejection fraction ≥ 50%, echocardiography confirmed centropericardial effusion, and ECG showed no clinically significant abnormal findings.
- There was no clinically significant pleural effusion. Baseline blood oxygen saturation under indoor ventilation was > 92%.
- The serum pregnancy test results of fertile women must be negative (women who have undergone surgical sterilization or at least 2 years after menopause are considered to be infertile).
Who cannot join
- The subject has had other malignancies, non-melanoma skin tumors, carcinoma in situ (e.g. Cervix, bladder, breast), unless disease-free survival of at least 3 years
- Presence or suspicion of uncontrollable fungal, bacterial, viral or other infections.
- Known human immunodeficiency virus (HIV) infection
- Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). Subjects with latent or prehepatitis B infection (defined as HBcAb positive and HBsAg negative) can be enrolled only if PCR tests for HBV DNA are negative. In addition, these subjects were required to undergo a monthly PCR test for HBV DNA. Participants who are serologically positive for HCV antibodies can also be enrolled if their PCR test results for HCV RNA are negative.
- Existing or past CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any CNS-related autoimmune disease
- Subjects with severe heart disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or any grade 3 (moderate) or 4 (severe) heart disease (according to the New York Heart Society Functional Grading Method NYHA) with lymphoma infiltrating the heart's atria or ventricles
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- A history of myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart disease in the 12 months prior to enrollment
- Emergency treatment is expected or likely to occur within 6 weeks due to rapid tumor progression (e.g. tumor mass compression)
- Primary immune deficiency
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment
- Any medical condition that may affect the evaluation of safety or efficacy
- Have had severe rapid hypersensitivity reactions to any of the drugs to be used in this study
- Administer live vaccine within ≤6 weeks prior to initiation of the pretreatment regimen
- Pregnant or lactating female subjects
- Male or female subjects who do not consent to effective contraception from the time they sign informed consent until 6 months after completing AT19 treatment
- Subjects judged by the investigator had difficulty completing all visits or procedures required by the study protocol (including follow-up visits), or were not compliant enough to participate in the study
- In the past 2 years, subjects have had other malignancies, non-melanoma skin tumors, carcinoma in situ (e.g. Cervix, bladder, breast), end-organ damage due to autoimmune diseases (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or need to systematically administer immunosuppressive or other drugs for systemic disease control. Unless disease free survival of at least 3 years
- Participate in other clinical experimenters during the same period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The General Hospital of Western Theater Command
Chengdu, Sichuan
hai Yi, 0086-28-86571279, yihaimail@163.com
About this study
Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.
Read the detailed description
CD7 expression was determined by flow cytometry. After the target was determined, the subjects received the target dose of CD7 CAR-T from 1×105 to 1×108 /kg. Each subject will start with a low dose of 1×105/kg and if there are no significant side effects will be increased to the next dose until the maximum tolerated dose is reached. A variety of adverse events (including neurological events, hematological events, infections, and secondary tumors) will be collected from the time of infusion of CAR T cells to 24 months after infusion. To understand the complete response rate (CR) and partial response rate (PR) at 3 months; Recurrence rate, progression-free survival (PFS) and overall survival (OS) after 1 to 5 years of CD7 CAR-T reinfusion; The amount and duration of CD7 CAR-T in vivo.
- Conditions
- Acute-Leukemia
- Being tested
- CD7 CAR-T cell
- Keywords
- Acute-Leukemia, Relapsed, Refractory
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD7 CAR-T cellBiological
Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (1-100)x10^6 CD7 CAR-T cells/kg]
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | CD7 positive relapsed or refractory acute leukemia Receives: Biological: CD7 CAR-T cell |
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 V4.03
Measured: 12 months
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: 24 months
Secondary outcomes (3)
Duration of overall response (DOR)
Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up
Measured: 24 months
Progression-free survival(PFS)
PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Measured: 24 months
Overall survival(OS)
OS will be assessed from the CAR-T cell infusion to death or last follow-up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start18 Feb 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Collaborators
- YakeBiotech Ltd.
- Responsible party
- Sponsor
- Investigators
- Hai Yi, Ph.D, Principal investigator, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585345
- Sponsor's protocol ID
- GHWesternTheaterCommand
- Status last verified
- Sep 2024
- First submitted
- 7 Jul 2024
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia
- ClinicalTrials.gov ID
- NCT06585345
- Acronym / sponsor ID
- GHWesternTheaterCommand
- Conditions
- Acute-Leukemia
- Keywords
- Acute-Leukemia, Relapsed, Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Collaborators
- YakeBiotech Ltd.
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 5 Sep 2024 (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.
Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.
Detailed description
CD7 expression was determined by flow cytometry. After the target was determined, the subjects received the target dose of CD7 CAR-T from 1×105 to 1×108 /kg. Each subject will start with a low dose of 1×105/kg and if there are no significant side effects will be increased to the next dose until the maximum tolerated dose is reached. A variety of adverse events (including neurological events, hematological events, infections, and secondary tumors) will be collected from the time of infusion of CAR T cells to 24 months after infusion. To understand the complete response rate (CR) and partial response rate (PR) at 3 months; Recurrence rate, progression-free survival (PFS) and overall survival (OS) after 1 to 5 years of CD7 CAR-T reinfusion; The amount and duration of CD7 CAR-T in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: CD7 CAR-T cellCD7 positive relapsed or refractory acute leukemia |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients diagnosed with acute leukemia.
- Acute leukemia complex/refractory cases with poor response to conventional chemotherapy: 1) patients who did not achieve complete remission after 2 courses of treatment with standard induced remission regimen; 2) Recurrence within 6 months after the first remission; 3) Relapse 6 months after the first remission, but failure to be treated again with the original induced remission regimen; 4) Recurrent patients.
- At least 2 weeks or 5 half-lives (whichever is shorter) from the start of preconditioning chemotherapy after prior systemic treatment, except for immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitor/agonist treatment is at least 3 half-lives away from pre-treatment chemotherapy (e.g., ipilimumab, etc.).
- Toxic reactions caused by previous antitumor therapy must be stabilized and returned to ≤ grade 1 (except for clinically insignificant toxicity, such as baldness).
- Over 14 years old, under 65 years old.
Key exclusion criteria (18 listed)
- The subject has had other malignancies, non-melanoma skin tumors, carcinoma in situ (e.g. Cervix, bladder, breast), unless disease-free survival of at least 3 years
- Presence or suspicion of uncontrollable fungal, bacterial, viral or other infections.
- Known human immunodeficiency virus (HIV) infection
- Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). Subjects with latent or prehepatitis B infection (defined as HBcAb positive and HBsAg negative) can be enrolled only if PCR tests for HBV DNA are negative. In addition, these subjects were required to undergo a monthly PCR test for HBV DNA. Participants who are serologically positive for HCV antibodies can also be enrolled if their PCR test results for HCV RNA are negative.
- Existing or past CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any CNS-related autoimmune disease
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 |
|---|---|---|
| CD7 CAR-T cellSplit intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (1-100)x10^6 CD7 CAR-T cells/kg] | Biological | Experimental group |
Primary outcome
Number of Adverse Events
Time frame: 12 months
Adverse events are evaluated with CTCAE V4.03
Overall response rate (ORR)
Time frame: 24 months
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%.
3 secondary outcomes
Duration of overall response (DOR)
Time frame: 24 months
Progression-free survival(PFS)
Time frame: 24 months
Overall survival(OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
Hai Yi, Ph.D principal investigator
The General Hospital of Western Theater Command
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 CD7 CAR-T cell in people with Acute-Leukemia, run by The General Hospital of Western Theater Command 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 12 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 5 Sep 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai Yi, Ph.D (0086-28-86571279, yihaimail@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). The study lists 2 primary outcomes in all. 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 5 Sep 2024.