About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- CD7 CAR-T combined with autologous hematopoietic stem cell transplantation
Treatment groups
Sponsors and collaborators
Zhengzhou University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator