uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

NCT07109518 | Recruiting Phase 1

• 1 other identifier: IIT2025073
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.

Conditions

Acute Myeloid Leukemia (AML); T Lymphoblastic Leukemia/Lymphoma

Keywords

Universal CD7 CAR-T (uCD7 CAR-T); Acute myeloid leukemia (AML); T lymphoblastic leukemia/lymphoma (T-ALL/LBL); Prospective study; Single-arm Clinical Study

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity（DLT） Any toxicity associated with uCD7 CAR-T cells, or life-threatening hematological or non-hematological toxicity.

  Any toxicity associated with uCD7 CART cells, or life-threatening hematological or non-hematological toxicity.

  3 months after uCD7 CART cells infusion

• Number of adverse event of CD7 CART cells treatment

  Participants will be followed for the duration of the treatment, an expected average of 24 months.

Secondary Outcomes (6)

• Response rate in 3 months

  3 months after uCD7 CART cells infusion

• Duration of remission (DOR）

  Participants will be followed for the duration of the treatment, an expected average of 24 months.

• Event-free survival (EFS)

  Participants will be followed for the duration of the treatment, an expected average of 24 months.

• Leukemia-free Survival (LFS）

  Participants will be followed for the duration of the treatment, an expected average of 24 months.

• Proportion of patients receiving hematopoietic stem cell

  Participants will be followed for the duration of the treatment, an expected average of 24 months.

Study Arms (1)

uCD7 CART

EXPERIMENTAL

Two cohorts were established: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. A 3+3 dose escalation and rapid titration design was used to explore the maximum tolerated dose (MTD) for each cohort. During the accelerated titration phase, dose-limiting toxicity (DLT) assessments were performed for 1 subject per enrollment and dose escalation was performed until the first DLT event was observed. 3+3 dose escalation CAR-T dose groups were (1) 0.5×10\^6 CART cells/kg; (2)1×10\^6 CART cells/kg;(3) 3×10\^6 CART cells/kg. DLT assessments will be performed first for the first 3 subjects at each dose level (including the last subject at the end of rapid titration) and then for 1 to 3 subjects per enrollment. Therefore, a minimum of 4 and a maximum of 12 patients are expected to be enrolled.

Biological: uCD7 CART

Interventions

uCD7 CART BIOLOGICAL

Subjects screened to meet the requirements for uCD7 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine (Flu) and cyclophosphamide (CTX) based preconditioning should be performed within 1 week prior to uCD7 CART infusion: Flu 30mg/m2 ×3 days; CTX 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and etoposide. Infusion of uCD7 CART must be performed 24 hours after completion of chemotherapy preconditioning. uCD7 CART can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.

uCD7 CART

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and \<70 years, regardless of gender;
• T-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and T-cell Lymphoma Clinical Practice Guidelines (2020.v1);
• Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;
• Cytology confirmed that the tumor cells were CD7 positive.
• Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
• Complies with the diagnosis of relapsed/refractory AML, including any of the following conditions according to China Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2021 Edition):
• Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy;
• CR after consolidation chemotherapy, relapse within 12 months;
• Relapse 12 months after remission but ineffective after conventional chemotherapy;
• or more relapses;
• Relapse after hematopoietic stem cell transplantation.
• Meet the diagnosis of relapsed/refractory T-ALL/LBL, including any of the following:
• Primary refractory patients who have not achieved complete response after two cycles of standard chemotherapy, or patients who have not achieved complete response after multi-line rescue chemotherapy;
• Relapse within \<12 months after complete remission or ≥12 months after complete remission and fail to achieve complete remission induced by 1 or more cycles of standard treatment;
• Relapse after hematopoietic stem cell transplantation or relapse after CAR-T therapy at the same target;

You may not qualify if:

• Subjects who met any of the following criteria were excluded from the study:
• acute promyelocytic leukemia (APL);
• Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
• Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
• Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:
• Systemic chemotherapy (except for pretreatment) within 1 week;
• For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening;
• Received donor lymphocyte infusion (DLI) within 6 weeks;
• Presence of uncontrolled, serious, active infection at screening;
• Patients with a history of serious heart disease, including: severe cardiac insufficiency (subjects with cardiac insufficiency of Class III or IV according to the New York Heart Association (NYHA) cardiac function classification standard), myocardial infarction within 12 months or cardiac angioplasty or stenting, unstable angina pectoris, ECG indicating significant QT interval prolongation (\>480ms) or serious arrhythmia judged by the investigator;
• Previous craniocerebral trauma, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral vascular hemorrhagic disease and other medical history, and within six months of the need for drug treatment;
• Patients with hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis antibody test positive, EBER positive or EBV copy number greater than the upper limit of normal at screening;
• Patients who must use steroid hormones during CAR-T infusion (except for local or inhaled steroid hormones); subjects who are receiving systemic steroid therapy before screening and need long-term systemic steroid therapy during treatment according to the investigator's judgment (except for inhaled or local use);
• Subjects with autoimmune diseases requiring treatment, immunodeficient subjects, or subjects requiring immunosuppressive treatment;
• Patients with acute graft-versus-host disease (GvHD) or moderate-to-severe chronic GvHD within 4 weeks prior to screening;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jianxiang Wang

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxiang Wang

CONTACT

+862223909120; wangjx@ihcams.ac

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: June 28, 2025
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): June 28, 2030
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)