T-ALLNCT04785833
CD7 CAR-T in the Treatment of CD7 Positive Refractory Relapsed Acute Leukemia
A study testing T cell injection targeting CD7 chimeric antigen receptor in people with T-ALL, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- T-ALL
- What is being tested?
- T cell injection targeting CD7 chimeric antigen receptor
- 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
- 4 Mar 2021to 4 Feb 2024
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12-65
- Sign informed consent
- Expected survival time ≥ 3 months
- CD7 positive refractory and relapsed acute leukemia
- Karnofsky score≥60
- ECOG score ≤ 2
- Have not received other immunotherapy within 3 months
- The CD7 expression rate on the surface of leukemia cells detected by flow cytometry is greater than 30%
Who cannot join
- Uncontrolled active infection
- Active viral hepatitis B or C
- HIV test positive
- Congenital immunodeficiency patients
- Pregnant and breastfeeding patients
- Patients with central nervous system tumors or central nervous system leukemia
- The patient and/or family members do not agree to the treatment plan
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliared Hospital Of SOOCHOW University
Suzhou, Jiangsu, 215006
xiaowen tang, 13913538266, xwtang1020@163.com
About this study
Official title: A Prospective, Open, Single-arm Clinical Study on the Efficacy and Safety of CD7 CAR-T in the Treatment of CD7-positive Refractory Relapsed Acute Leukemia
Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. CAR-T cells are costimulatory molecules that include single-chain antibodies (scFv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif ITAM), and intracellular signaling regions. The chimeric antigen receptor of CD28 or CD137(4-1BB) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous T cells, so that the modified CAR-T cells have targeting and specificity Recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen
- Conditions
- T-ALL
- Being tested
- T cell injection targeting CD7 chimeric antigen receptor
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T cell injection targeting CD7 chimeric antigen receptorDrug
Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation
| Study group | Role | What they receive |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental | Not described Receives: Drug: T cell injection targeting CD7 chimeric antigen receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-limiting toxicity
Measured: Up to 2 years
Secondary outcomes (3)
Safety results
Number of adverse events
Measured: Up to 2 years
PK
The maximum concentration (Cmax）
Measured: Up to 2 years
PD
Absolute value of CD7 Positive Cells in peripheral blood at each time point
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start4 Mar 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion4 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-ALLStudies of the same condition, open and under way.
- More trials run by PersonGen BioTherapeutics (Suzhou) Co., Ltd.The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785833
- Sponsor's protocol ID
- PA-CART-3-17-001
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Single-arm Clinical Study on the Efficacy and Safety of CD7 CAR-T in the Treatment of CD7-positive Refractory Relapsed Acute Leukemia
- ClinicalTrials.gov ID
- NCT04785833
- Acronym / sponsor ID
- PA-CART-3-17-001
- Conditions
- T-ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 4 Mar 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 4 Feb 2024 (estimated)
- First posted
- 8 Mar 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.
Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. CAR-T cells are costimulatory molecules that include single-chain antibodies (scFv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif ITAM), and intracellular signaling regions. The chimeric antigen receptor of CD28 or CD137(4-1BB) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous T cells, so that the modified CAR-T cells have targeting and specificity Recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental | Drug: T cell injection targeting CD7 chimeric antigen receptor |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 12-65
- Sign informed consent
- Expected survival time ≥ 3 months
- CD7 positive refractory and relapsed acute leukemia
- Karnofsky score≥60
Key exclusion criteria (7 listed)
- Uncontrolled active infection
- Active viral hepatitis B or C
- HIV test positive
- Congenital immunodeficiency patients
- Pregnant and breastfeeding patients
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 |
|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptorDrug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation | Drug | T cell injection targeting CD7 chimeric antigen receptor |
Primary outcome
DLT
Time frame: Up to 2 years
Dose-limiting toxicity
3 secondary outcomes
Safety results
Time frame: Up to 2 years
PK
Time frame: Up to 2 years
PD
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T cell injection targeting CD7 chimeric antigen receptor in people with T-ALL, run by PersonGen BioTherapeutics (Suzhou) 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 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 8 Mar 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.
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 (13913538266, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Up to 2 years). 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 8 Mar 2021.