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| Name | Class |
|---|---|
| Hebei Taihe Chunyu Biotechnology Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD7+ T cell lymphoma | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD7 CAR-T combined with autologous hematopoietic stem cell transplantation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy indicators | The objective response rates (ORR) | Day 28, Month 2, Month 3, Month 6, Month 12 after treatment |
| Efficacy indicators | The overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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;
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.).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xudong Zhang, Doctor | Contact | 86-0371-66279567 | fcczhangxd@zzu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University, Department of Oncology | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Day 28, Month 2, Month 3, Month 6, Month 12 after treatment |
| Efficacy indicators | The progression-free survival (PFS) | Day 28, Month 2, Month 3, Month 6, Month 12 after treatment |
| Efficacy indicators | Complete remission (CR) | Day 28, Month 2, Month 3, Month 6, Month 12 after treatment |
| Efficacy indicators | Event-free survival (EFS) | Day 28, Month 2, Month 3, Month 6, Month 12 after treatment |
| Efficacy indicators | Disease Control Rate (DOCR) | 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. | Day 28, Month 2, Month 3, Month 6, Month 12 after treatment |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |