CD7+ Acute LeukemiaPhase 1NCT04599556
Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
A Phase 1 study testing anti-CD7 CAR-T in people with CD7+ Acute Leukemia and CD7+ Lymphoma, run by Zhejiang University at 1 site in China.
Trial summary
This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- CD7+ Acute Leukemia, CD7+ Lymphoma
- What is being tested?
- anti-CD7 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 30 Dec 2025
- 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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
- Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- The estimated survival time is more than 3 months;
- ECOG score was 0-2;
- The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
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- For T-ALL/LBL:
- Patients is histologically diagnosed with CD7 Positive T-ALL/LBL according to the Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (2020. V1) by National Comprehensive Cancer Network (NCCN).
- The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:
- No CR was obtained by standard chemotherapy;
- The first induction was CR, but the duration of CR was less than 12 months;
- No CR was obtained after the first or multiple remedial treatment;
- Relapse twice or more;
- The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
- For T-NHL:
- Patients is histologically diagnosed with CD7 Positive T-NHL according to The 2016 revision of the World Health Organization classification of lymphoid neoplasms.
- r/r T-NHL, and includes any of the following conditions:
- No response or relapse after second or more lines of chemotherapy;
- Primary refractory ot chemotherapy;
- Relapse after autologous stem cell transplantation;
- According to the Lugano 2014 criteria, there is at least one evaluable tumor lesion.
- For AML:
- Patients is histologically diagnosed with CD7 Positive AML according to the Clinical Practice Guidelines for Acute Myeloid Leukemia (AML) (2020. V3) by National Comprehensive Cancer Network (NCCN).
- The diagnosis is consistent with r/r CD7 + AML, and includes any of the following conditions:
- No CR was obtained by standard chemotherapy;
- The first induction was CR, but the duration of CR was less than 12 months;
- No CR was obtained after the first or multiple remedial treatment;
- Relapse twice or more;
- The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
Who cannot join
- Patients with history of epilepsy or other central nervous system diseases;
- Patients with prolonged QT or severe heart disease;
- Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- The patients with uncontrolled active infection;
- Active hepatitis B or hepatitis C virus infection;
- Previous application of gene therapy;
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- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- Those who suffer from other uncontrolled diseases are not suitable to join the study;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
He Huang, PhD, 86-13605714822, hehuangyu@126.com
About this study
Official title: Clinical Trial for the Safety and Efficacy of Anti-CD7 Chimeric Antigen Receptor Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
- Conditions
- CD7+ Acute Leukemia, CD7+ Lymphoma
- Being tested
- anti-CD7 CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD7 CAR-TBiological
Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
| Study group | Role | What they receive |
|---|---|---|
| T-ALL/LBL | Experimental | Not described Receives: Biological: anti-CD7 CAR-T |
| T-NHL | Experimental | Not described Receives: Biological: anti-CD7 CAR-T |
| AML | Experimental | Not described Receives: Biological: anti-CD7 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Measured: 28 days
Treatment Emergent Adverse Event
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Apr 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CD7+ Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599556
- Sponsor's protocol ID
- CD7-001
- Status last verified
- Nov 2023
- First submitted
- 21 Oct 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812.
PubMed 38657244Xu X, Zu C, Zhang M, Xiao P, Hong R, Feng J, Xu H, Cui J, Yu J, Shi J, Wei G, Chang AH, Huang H, Hu Y. HLA Fully-Mismatched Sibling-Derived CD7 CAR-T Therapy Bridging to Haploidentical Hematopoietic Stem Cell Transplantation for Hepatosplenic gammadelta T-cell Lymphoma. Cell Transplant. 2023 Jan-Dec;32:9636897231194265. doi: 10.1177/09636897231194265.
PubMed 37667507
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Safety and Efficacy of Anti-CD7 Chimeric Antigen Receptor Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
- ClinicalTrials.gov ID
- NCT04599556
- Acronym / sponsor ID
- CD7-001
- Conditions
- CD7+ Acute Leukemia, CD7+ Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Oct 2020 (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 prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T-ALL/LBL | Experimental | Biological: anti-CD7 CAR-T |
| T-NHL | Experimental | Biological: anti-CD7 CAR-T |
| AML | Experimental | Biological: anti-CD7 CAR-T |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (29 listed)
- Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
- Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- The estimated survival time is more than 3 months;
- ECOG score was 0-2;
Key exclusion criteria (11 listed)
- Patients with history of epilepsy or other central nervous system diseases;
- Patients with prolonged QT or severe heart disease;
- Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- The patients with uncontrolled active infection;
- Active hepatitis B or hepatitis C virus 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 |
|---|---|---|
| anti-CD7 CAR-TLymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion | Biological | AML, T-ALL/LBL, T-NHL |
Primary outcome
Dose limiting toxicity
Time frame: 28 days
Treatment Emergent Adverse Event
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 38657244Hu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812.
- Derived from this study: PubMed 37667507Xu X, Zu C, Zhang M, Xiao P, Hong R, Feng J, Xu H, Cui J, Yu J, Shi J, Wei G, Chang AH, Huang H, Hu Y. HLA Fully-Mismatched Sibling-Derived CD7 CAR-T Therapy Bridging to Haploidentical Hematopoietic Stem Cell Transplantation for Hepatosplenic gammadelta T-cell Lymphoma. Cell Transplant. 2023 Jan-Dec;32:9636897231194265. doi: 10.1177/09636897231194265.
- 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.
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 anti-CD7 CAR-T in people with CD7+ Acute Leukemia and CD7+ Lymphoma, run by Zhejiang University 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 29 inclusion and 11 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 6 Dec 2023. 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 Yongxian Hu (+86-0571-87236476, huyongxian2000@aliyun.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). 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?
On the ClinicalTrials.gov record for NCT04599556, which also lists 2 linked publications.
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 6 Dec 2023.