CD7+ LymphomaNCT07008872
CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed/Refractory T Cell Lymphoma/Acute Leukemia
A study testing CD7 CART in people with CD7+ Lymphoma and CD7+ Acute Leukemia, run by Qi deng.
Trial summary
CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- CD7+ Lymphoma, CD7+ Acute Leukemia
- What is being tested?
- CD7 CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 May 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled:
- Subjects diagnosed with relapsed/refractory lymphoma/leukemia:
- Relapsed/refractory T-cell malignant lymphoma: patients who have not remission and recurrence after at least 2 courses of standardized second-line or above treatment (including hematopoietic stem cell transplantation).
- Relapsed/refractory T-cell acute lymphocytic or myeloid leukemia meeting any of the following criteria:
- Relapse: After achieving complete remission with a standard treatment regimen (including hematopoietic stem cell transplantation), blasts appear in peripheral blood or bone marrow (proportion>5%), or extramedullary diseases occur; ii) Refractory: No complete remission after at least two courses of standard induction therapy.
- Bone marrow flow cytometry detected tumor cells as CD7 and/or extramedullary lesions with a clear diagnosis of CD7 by pathological immunohistochemistry at the time of enrollment screening;
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- If tumor cells are detected in peripheral blood during enrollment screening, flow cytometry must be used to detect that the immunophenotype of tumor cells on the surface of tumor cells is both negative for CD4 and CD8. If the immunophenotype on the surface of peripheral blood tumor cells is not CD4 and CD8 negative, the proportion of peripheral blood tumor cells must be ≤1%;
- Expected survival greater than 3 months from the date of signing the informed consent form;
- Subjects with a performance status of 0~2 in the Eastern Cooperative Oncology Group (ECOG) score;
- 14 years old≤ age ≤ 75 years old, male or female;
- HGB at least ≥70g/L, blood transfusion is available;
- Liver and kidney function, heart and lung function meet the following requirements:
- creatinine ≤1.5×ULN;
- left ventricular ejection fraction ≥50%;
- Oxygen saturation >90%;
- Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN;
- Subject or guardian understands and signs the informed consent form.
Who cannot join
- One of the following cardiac criteria occurs: atrial fibrillation; Myocardial infarction within the past 12 months; Prolonged QT syndrome or secondary QT Extension, to be determined by the researcher. Echocardiography with LVSF<30% or LVEF<50%; Clinically significant pericardial effusion; Heart function Incomplete NYHA III or IV (confirmed by echocardiography within 12 months after treatment);
- Active GVHD;
- Have a history of severe pulmonary dysfunction;
- Merge other advanced malignant tumors;
- Combination of severe or persistent infections that cannot be effectively controlled;
- Combination of severe autoimmune diseases or congenital immunodeficiency;
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- Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA ≥ 500 IU/ml and abnormal liver function] or anti hepatitis C virus Positive for HCV Ab, HCV-RNA above the detection limit of the analytical method, and abnormal liver function;
- Human immunodeficiency virus (HIV) infection or syphilis infection;
- Have a history of severe allergies to biological products (including antibiotics);
- There are central nervous system disorders, such as uncontrolled epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, etc;
- Female patients who are pregnant or breastfeeding, or have a pregnancy plan within 12 months;
- The researcher believes that there may be situations that increase the risk to the subjects or interfere with the test results.
About this study
Official title: Clinical Study on the Efficacy and Safety of CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed/Refractory T Cell Lymphoma/Acute Leukemia
CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed/refractory hematologic malignancies.
- Conditions
- CD7+ Lymphoma, CD7+ Acute Leukemia
- Being tested
- CD7 CART
- Keywords
- CD7 CART, AL, lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD7 CARTBiological
For intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CD7 CAR-T | Experimental | For intravenous infusion Receives: Biological: CD7 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
the incidence and severity of immune therapy related toxic reactions (irAEs)
Measured: up to one month after the CAR-T infusion
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
CR rate on M1 and M3
Measured: one month and three month after the CAR-T infusion
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
ORR(CR and PR) on M1 and M3
Measured: one month and three month after the CAR-T infusion
Secondary outcomes (7)
long-term efficacy
DOR
Measured: up to one year after the CAR-T infusion
long-term efficacy
PFS
Measured: up to one year after the CAR-T infusion
long-term efficacy
OS
Measured: up to one year after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
CAR-T/T% by flow cytometry
Measured: Day7, Day10, Day14, Day28 after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
CARgene copy numbers by qPCR
Measured: Day7, Day10, Day14, Day28 after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Area under the plasma concentration versus time curve(AUC)
Measured: up to one month after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Peak Plasma Concentration (Cmax)
Measured: up to one mpnth after the CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD7+ LymphomaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qi deng
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Responsible party
- Sponsor-investigator, Qi deng, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008872
- Sponsor's protocol ID
- XB-20240912-1
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed/Refractory T Cell Lymphoma/Acute Leukemia
- ClinicalTrials.gov ID
- NCT07008872
- Acronym / sponsor ID
- XB-20240912-1
- Conditions
- CD7+ Lymphoma, CD7+ Acute Leukemia
- Keywords
- CD7 CART, AL, lymphoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qi dengUniversity, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Jun 2025 (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.
CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed/refractory hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD7 CAR-T | Experimental | Biological: CD7 CARTFor intravenous infusion |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects diagnosed with relapsed/refractory lymphoma/leukemia:
- Bone marrow flow cytometry detected tumor cells as CD7 and/or extramedullary lesions with a clear diagnosis of CD7 by pathological immunohistochemistry at the time of enrollment screening;
- If tumor cells are detected in peripheral blood during enrollment screening, flow cytometry must be used to detect that the immunophenotype of tumor cells on the surface of tumor cells is both negative for CD4 and CD8. If the immunophenotype on the surface of peripheral blood tumor cells is not CD4 and CD8 negative, the proportion of peripheral blood tumor cells must be ≤1%;
- Expected survival greater than 3 months from the date of signing the informed consent form;
- Subjects with a performance status of 0~2 in the Eastern Cooperative Oncology Group (ECOG) score;
Key exclusion criteria (12 listed)
- One of the following cardiac criteria occurs: atrial fibrillation; Myocardial infarction within the past 12 months; Prolonged QT syndrome or secondary QT Extension, to be determined by the researcher. Echocardiography with LVSF<30% or LVEF<50%; Clinically significant pericardial effusion; Heart function Incomplete NYHA III or IV (confirmed by echocardiography within 12 months after treatment);
- Active GVHD;
- Have a history of severe pulmonary dysfunction;
- Merge other advanced malignant tumors;
- Combination of severe or persistent infections that cannot be effectively controlled;
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 CARTFor intravenous infusion | Biological | CD7 CAR-T |
Primary outcome
Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
Time frame: up to one month after the CAR-T infusion
the incidence and severity of immune therapy related toxic reactions (irAEs)
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
Time frame: one month and three month after the CAR-T infusion
CR rate on M1 and M3
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
Time frame: one month and three month after the CAR-T infusion
ORR(CR and PR) on M1 and M3
7 secondary outcomes
long-term efficacy
Time frame: up to one year after the CAR-T infusion
long-term efficacy
Time frame: up to one year after the CAR-T infusion
long-term efficacy
Time frame: up to one year after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Time frame: Day7, Day10, Day14, Day28 after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Time frame: Day7, Day10, Day14, Day28 after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Time frame: up to one month after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
Time frame: up to one mpnth after the CAR-T infusion
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 6 Jun 2025.
Related trials for CD7+ Lymphoma
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Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells
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RecruitingPhase 2
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)
T-cell Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Not yet recruitingPhase 1
Universal 4SCAR7U Targeting CD7-positive Malignancies
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Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies
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Enrolling by invitationPhase 1
A Clinical Study of HY035 Cell Injection in the Treatment of CD7-positive Relapsed or Refractory Hematologic Malignancies
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CD7 CART in people with CD7+ Lymphoma and CD7+ Acute Leukemia, run by Qi deng.
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 17 inclusion and 12 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: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia (time frame: up to one month after the CAR-T 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 6 Jun 2025.