CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age14-65
SponsorZhengzhou University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CD7 CAR-T combined with autologous hematopoietic stem cell transplantation
DrugPhase 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.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: CD7+ T cell lymphomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 28 after treatmentSecondary outcomes
1
Efficacy indicators
The objective response rates (ORR)
Time frame
Day 28, Month 2, Month 3, Month 6, Month 12 after treatment2
Efficacy indicators
The overall survival (OS)
Time frame
Day 28, Month 2, Month 3, Month 6, Month 12 after treatment3
Efficacy indicators
The progression-free survival (PFS)
Time frame
Day 28, Month 2, Month 3, Month 6, Month 12 after treatment4
Efficacy indicators
Complete remission (CR)
Time frame
Day 28, Month 2, Month 3, Month 6, Month 12 after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhengzhou University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
Source ClinicalTrials.gov
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