CD7+ LymphomaPhase 1/2NCT07117305
CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation
A Phase 1/2 study testing CD7 CAR-T combined with autologous hematopoietic stem cell transplantation in people with CD7+ Lymphoma and T Cell Lymphoma, run by Zhengzhou University at 1 site in China.
Trial summary
This is a single-arm, open-label, phase I/II clinical trial initiated by investigators to evaluate the safety, tolerability, and preliminary efficacy of CD7-targeted chimeric antigen receptor T cells (CD7 CAR-T) combined with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory… Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- CD7+ Lymphoma, T Cell Lymphoma
- What is being tested?
- CD7 CAR-T combined with autologous hematopoietic stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Dec 2027
- 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
- With the patient's explicit consent and after signing the informed consent form, the patient is willing and capable of complying with the planned visits, research treatments, laboratory tests and other trial procedures;
- Age range: 14 to 65 years old. Both men and women are eligible;
- All types of CD7+ T-cell non-Hodgkin's lymphomas (except T-lymphoblastic lymphoma) diagnosed according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022);
- For patients with T-cell lymphoma who are refractory to the first-line chemotherapy regimen or who experience recurrence and resistance after at least the second-line chemotherapy regimen. The following criteria must be met: a. For those patients who had only received first-line treatment previously, if they did not achieve PR after at least 4 cycles of the first-line regimen, or if they did not achieve CR after at least 6 cycles of the first-line regimen; b. Those who experienced recurrence in the early stage (< 12 months) after complete remission; or those who experienced recurrence in the late stage (≥ 12 months) and did not achieve remission after one course of standard induction chemotherapy; c. Those who have not achieved remission after treatment with second-line or more chemotherapy regimens;
- During the enrollment screening process, the subjects were confirmed to have CD7+ (with CD7 expression ≥ 10%) through pathological histology and/or cytology;
- Having measurable or evaluable lesions: The target lesion is defined as a lesion within lymph nodes with a long diameter of ≥ 15mm, or an extranodal lesion larger than 10mm (in accordance with the Lugano 2014 criteria); Lesions that have received prior radiotherapy are considered measurable only if there is a clear progression after completing radiotherapy; or PET-positive lesions determined according to the Lugano criteria;
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- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 2, and the estimated survival period is greater than 3 months;
- Having appropriate organ functions: a. The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤ 3 times the upper limit of normal (ULN). If the abnormality of ALT and AST is judged to be caused by the disease (such as liver infiltration or bile duct obstruction), the thresholds can be relaxed to ≤ 5 times ULN; b. Total serum bilirubin ≤ 2 times ULN, except in cases where Gilbert syndrome is present; patients with Gilbert syndrome whose total bilirubin is ≤ 3 times ULN and direct bilirubin is ≤ 1.5 times ULN can be included; c. Serum creatinine ≤ 1.5 times the upper limit of normal, or creatinine clearance rate ≥ 60 mL/min; d. The international normalized ratio (INR) is no more than 1.5 times the upper limit of normal (ULN), and the activated partial thromboplastin time (aPTT) is no more than 1.5 times the ULN; e. Having the lowest level of lung reserve, defined as ≤ grade 1 dyspnea (CTCAE v5.0) and a blood oxygen saturation of ≥ 92% in the absence of oxygen supplementation; f. Left ventricular ejection fraction in echocardiography is ≥ 50%; no clinically significant abnormal electrocardiogram findings; no clinically significant pericardial effusion or pleural effusion.
- Female participants of childbearing potential must have negative blood/urine pregnancy tests within 7 days prior to infusion. All sexually active males and females with reproductive capacity must agree to use highly effective contraception throughout the study and for at least 2 years after administration of the investigational treatment.
Who cannot join
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) <50%；
- Documented history of severe pulmonary impairment；
- History of organ transplantation or active graft-versus-host disease (GVHD);
- Concurrent other progressive malignancies;
- Uncontrolled severe infections;
- Severe autoimmune diseases or primary immunodeficiency disorders;
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- Positive for any of the following: Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); Hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) with HBV-DNA levels above the upper limit of normal (ULN); Hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA; Human immunodeficiency virus antibody (HIV-Ab); Treponema pallidum antibody (TP-Ab); Cytomegalovirus (CMV) DNA above ULN; Epstein-Barr virus (EBV) DNA above ULN；
- History of severe hypersensitivity to biological products (including antibiotics);
- Pre-existing central nervous system disorders, including but not limited to:
- Uncontrolled epilepsy；Cerebral ischemia/hemorrhage；Dementia；Cerebellar disorders；
- Previous recipients of autologous or allogeneic hematopoietic stem cell transplantation;
- Any other severe physical or psychiatric conditions or significant laboratory abnormalities that may: Increase study participation risks；Interfere with study results interpretation; Be deemed by investigators to render the patient unsuitable for study participation;
- Presence of lymphoma-related clinical emergencies requiring immediate intervention at screening due to tumor mass obstruction or compression (e.g., intestinal obstruction, vascular compression, etc.).
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
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
Zhengzhou, Henan, 450052
About this study
Official title: A Clinical Investigation Into the Safety and Efficacy of CD7 Chimeric Antigen Receptor T-cell (CAR-T) Therapy in Combination With Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed/Refractory T-cell Lymphoma
This is a single-arm, open-label, phase I/II clinical trial initiated by investigators to evaluate the safety, tolerability, and preliminary efficacy of CD7-targeted chimeric antigen receptor T cells (CD7 CAR-T) combined with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory CD7-positive T-cell lymphomas. Phase I adopts a standard 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy. The study includes lymphodepletion chemotherapy, ASCT, and sequential infusion of CD7 CAR-T cells. The primary objectives include: (1) Evaluate safety/tolerability of CD7 CAR-T + auto-HSCT in relapsed or refractory CD7-positive T-cell lymphomas. (2) Determine MTD and RP2D. The secondary objectives include: (1) Assess efficacy (overall response rate, complete response, duration of response, progression-free survival and overall survival. (2)Characterize PK/PD profiles. (3)Investigate anti-tumor mechanisms.
- Conditions
- CD7+ Lymphoma, T Cell Lymphoma
- Being tested
- CD7 CAR-T combined with autologous hematopoietic stem cell transplantation
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD7 CAR-T combined with autologous hematopoietic stem cell transplantationDrug
Phase I adopts a standard 3+3 dose-escalation design (with exploratory doses of 1×10⁶, 2×10⁶, and 2.5×10⁶ CAR⁺ cells/kg) to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy.
During screening, eligible patients will be identified and consented. In the collection phase, patients undergo two separate apheresis procedures: G-CSF-mobilized peripheral blood stem cell collection for ASCT and PBMC collection for CAR-T manufacturing. Bridging therapy and gut preparation may be performed. The pretreatment phase(recommended: BEAM therapy) starts from Day -8. Investigators may adjust the pretreatment regimen based on the patient's performance. On Day 0, autologous stem cells are infused. CD7 CAR-T cells are infused on Days 2-7 post-transplant. Follow-up visits occur on Days 10, 14, 21, 28, and Months 2, 3, 6, and 12.
| Study group | Role | What they receive |
|---|---|---|
| CD7+ T cell lymphoma | Experimental | Not described Receives: Drug: CD7 CAR-T combined with autologous hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of CD7 CAR-T cell injection combined with autologous hematopoietic stem cell transplantation
The possible adverse reactions recorded in each item were evaluated.
Measured: Day 28 after treatment
Secondary outcomes (7)
Efficacy indicators
The objective response rates (ORR)
Measured: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
The overall survival (OS)
Measured: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
The progression-free survival (PFS)
Measured: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Complete remission (CR)
Measured: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Event-free survival (EFS)
Measured: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Disease Control Rate (DOCR)
Measured: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
kinetics of CAR-T cells
Use flow cytometry or Q-PCR to monitor the kinetics of CAR-T cells.
Measured: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Dec 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Responsible party
- Principal investigator, Mingzhi Zhang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117305
- Sponsor's protocol ID
- 2025-Th-C252-V1.0
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2025
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Into the Safety and Efficacy of CD7 Chimeric Antigen Receptor T-cell (CAR-T) Therapy in Combination With Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed/Refractory T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07117305
- Acronym / sponsor ID
- 2025-Th-C252-V1.0
- Conditions
- CD7+ Lymphoma, T Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Aug 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.
This is a single-arm, open-label, phase I/II clinical trial initiated by investigators to evaluate the safety, tolerability, and preliminary efficacy of CD7-targeted chimeric antigen receptor T cells (CD7 CAR-T) combined with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory CD7-positive T-cell lymphomas. Phase I adopts a standard 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy. The study includes lymphodepletion chemotherapy, ASCT, and sequential infusion of CD7 CAR-T cells. The primary objectives include: (1) Evaluate safety/tolerability of CD7 CAR-T + auto-HSCT in relapsed or refractory CD7-positive T-cell lymphomas. (2) Determine MTD and RP2D. The secondary objectives include: (1) Assess efficacy (overall response rate, complete response, duration of response, progression-free survival and overall survival. (2)Characterize PK/PD profiles. (3)Investigate anti-tumor mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD7+ T cell lymphoma | Experimental | Drug: CD7 CAR-T combined with autologous hematopoietic stem cell transplantation |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- With the patient's explicit consent and after signing the informed consent form, the patient is willing and capable of complying with the planned visits, research treatments, laboratory tests and other trial procedures;
- Age range: 14 to 65 years old. Both men and women are eligible;
- All types of CD7+ T-cell non-Hodgkin's lymphomas (except T-lymphoblastic lymphoma) diagnosed according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022);
- For patients with T-cell lymphoma who are refractory to the first-line chemotherapy regimen or who experience recurrence and resistance after at least the second-line chemotherapy regimen. The following criteria must be met: a. For those patients who had only received first-line treatment previously, if they did not achieve PR after at least 4 cycles of the first-line regimen, or if they did not achieve CR after at least 6 cycles of the first-line regimen; b. Those who experienced recurrence in the early stage (< 12 months) after complete remission; or those who experienced recurrence in the late stage (≥ 12 months) and did not achieve remission after one course of standard induction chemotherapy; c. Those who have not achieved remission after treatment with second-line or more chemotherapy regimens;
- During the enrollment screening process, the subjects were confirmed to have CD7+ (with CD7 expression ≥ 10%) through pathological histology and/or cytology;
Key exclusion criteria (13 listed)
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) <50%；
- Documented history of severe pulmonary impairment；
- History of organ transplantation or active graft-versus-host disease (GVHD);
- Concurrent other progressive malignancies;
- Uncontrolled severe infections;
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 combined with autologous hematopoietic stem cell transplantationPhase I adopts a standard 3+3 dose-escalation design (with exploratory doses of 1×10⁶, 2×10⁶, and 2.5×10⁶ CAR⁺ cells/kg) to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy. During screening, eligible patients will be identified and consented. In the collection phase, patients undergo two separate apheresis procedures: G-CSF-mobilized peripheral blood stem cell collection for ASCT and PBMC collection for CAR-T manufacturing. Bridging therapy and gut preparation may be performed. The pretreatment phase(recommended: BEAM therapy) starts from Day -8. Investigators may adjust the pretreatment regimen based on the patient's performance. On Day 0, autologous stem cells are infused. CD7 CAR-T cells are infused on Days 2-7 post-transplant. Follow-up visits occur on Days 10, 14, 21, 28, and Months 2, 3, 6, and 12. | Drug | CD7+ T cell lymphoma |
Primary outcome
The safety of CD7 CAR-T cell injection combined with autologous hematopoietic stem cell transplantation
Time frame: Day 28 after treatment
The possible adverse reactions recorded in each item were evaluated.
7 secondary outcomes
Efficacy indicators
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
kinetics of CAR-T cells
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
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 12 Aug 2025.
- 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.
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 combined with autologous hematopoietic stem cell transplantation in people with CD7+ Lymphoma and T Cell Lymphoma, run by Zhengzhou 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 9 inclusion and 13 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 12 Aug 2025. 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 Xudong Zhang, Doctor (86-0371-66279567, fcczhangxd@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of CD7 CAR-T cell injection combined with autologous hematopoietic stem cell transplantation (time frame: Day 28 after treatment). 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 12 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.