T-cell Acute Lymphoblastic LeukemiaPhase 1NCT04934774
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
A Phase 1 study testing CD7 CAR T cells in people with T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, run by iCell Gene Therapeutics at 1 site in China.
Trial summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, T-cell Non-Hodgkin Lymphoma
- What is being tested?
- CD7 CAR T cells
- 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 Dec 2020to 1 Jun 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
- Signed written informed consent; Patients volunteer to participate in the research
- Diagnosis is mainly based on the World Health Organization (WHO) 2008
- Patients have exhausted standard therapeutic options
- Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
- Female must be not pregnant during the study
Who cannot join
- Patients declining to consent for treatment
- Prior solid organ transplantation
- Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Any drug used for GVHD must be stopped >1 week
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Hongyu Zhang, MD/PhD, Hongyu.Zhang@pkuszh.com
About this study
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia
Read the detailed description
Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.
- Conditions
- T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, T-cell Non-Hodgkin Lymphoma
- Being tested
- CD7 CAR T cells
- Keywords
- Anti-CD7 CAR, CD7CAR, T cell leukoma/lymphoma, T-ALL, T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD7 CAR T cellsBiological
Non-gene edited anti-CD7 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD7 CAR T cells | Experimental | anti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg. Receives: Biological: CD7 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: The first 28 days after infusion
Type of dose-limiting toxicity (DLT)
Type of dose-limiting toxicity (DLT)
Measured: The first 28 days after infusion
Adverse event by severity
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Secondary outcomes (3)
Overall response rate of ant-CD7 CAR
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Measured: 1 year
Progression-free survival (PFS)
Progression-free survival (PFS)
Measured: 1 year
Overall survival
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Dec 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iCell Gene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital
- Responsible party
- Sponsor
- Investigators
- Hongyu Zhang, Principal investigator, Peking University Shenzhen Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934774
- Sponsor's protocol ID
- ICG177-001
- Status last verified
- Jun 2021
- First submitted
- 27 Feb 2021
- Last updated
- 22 Jun 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 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
- ClinicalTrials.gov ID
- NCT04934774
- Acronym / sponsor ID
- ICG177-001
- Conditions
- T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, T-cell Non-Hodgkin Lymphoma
- Keywords
- Anti-CD7 CAR, CD7CAR, T cell leukoma/lymphoma, T-ALL, T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- iCell Gene TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 Jun 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 phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia
Detailed description
Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD7 CAR T cells | Experimental | Biological: CD7 CAR T cellsanti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent; Patients volunteer to participate in the research
- Diagnosis is mainly based on the World Health Organization (WHO) 2008
- Patients have exhausted standard therapeutic options
- Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
- Female must be not pregnant during the study
Key exclusion criteria (4 listed)
- Patients declining to consent for treatment
- Prior solid organ transplantation
- Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Any drug used for GVHD must be stopped >1 week
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 cellsNon-gene edited anti-CD7 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy. | Biological | anti-CD7 CAR T cells |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: The first 28 days after infusion
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Type of dose-limiting toxicity (DLT)
Time frame: The first 28 days after infusion
Type of dose-limiting toxicity (DLT)
Adverse event by severity
Time frame: 2 years
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
3 secondary outcomes
Overall response rate of ant-CD7 CAR
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 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.
Hongyu Zhang principal investigator
Peking University Shenzhen Hospital, China
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 CD7 CAR T cells in people with T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, run by iCell Gene Therapeutics 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 5 inclusion and 4 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 22 Jun 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 Kevin Pinz, MS (6315386218, kevin.pinz@icellgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: The first 28 days after infusion). The study lists 3 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 22 Jun 2021.