Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies

NCT05290155 | Completed Phase 1

• 1 other identifier: SHYSXY-202105-CD7-CART
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies

Conditions

T Lymphoblastic Leukemia/Lymphoma; T-cell Acute Lymphoblastic Leukemia; Peripheral T Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Anaplastic Large Cell Lymphoma

Keywords

chimeric antigen receptor T cell; T lymphoblastic lymphoma/leukemia; T cell non-Hodgkin lymphoma; CD7

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  The occurence of study related adverse effects defined by NCI CTCAE5.0

  28 days post infusion

Secondary Outcomes (7)

• CAR-T cell expansion

  2 years post infusion

• CAR-T cell persistence

  2 years post infusion

• Number of CD7+ lymphocytes of peripheral blood

  2 years post infusion

• Total response rate (ORR) after administration

  3 months post infusion

• Duration of remission (DOR) after administration

  2 years post infusion

Other Outcomes (1)

• Immunogenicity of CAR-T cells

  2 years post infusion

Study Arms (1)

Anti-CD7 CAR T cells

EXPERIMENTAL

Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients

Drug: anti-CD7 CAR-T cells

Interventions

anti-CD7 CAR-T cells DRUG

Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients

Anti-CD7 CAR T cells

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fourteen to 70 Years Old, Male and female;
• Expected survival \> 12 weeks; ECOG score 0-2;
• Confirmed diagnosis of acute T cell leukemia and screened for CD7 positive,including following conditions:a. Patients who do not get a CR with ≥2 prior induction therapy b. Those who achieves CR, but have a early relapse(\<12months),or a late relapse (\>=12months) failing to acheive a CR after re-induction chemotherapy c. For any Patiens failed ASCT/allo-SCT
• Relapsed and refractory patients with diagnosis of CD7 positive T cell lymphoma have had≥2 prior lines of therapy,who do not acheive at least a PR, or have a relapse including:a. Peripheral T cell lymphoma NOS, or b.Angioimmunoblastic T cell lymphoma,or c. Anaplastic large cell lymphoma c.Disease can be assessed(BM or CT scan)
• Confirmed T lymphoblastic lymphoma：a. Patients who do not get a PR with ≥2 induction chemotherapy or a CR with ≥ 4 induction chemotherapy b. Relapsed patients failing to achieve a CR after 1 line salvage chemotherapy c. For any Patients failed ASCT/allo-SCT .Disease can be assessed(BM or CT scan)
• The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
• Liver, kidney and cardiopulmonary functions meet the following requirements: a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction \>50%; c.Baseline oxygen saturation\>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST≤ 3×ULN;
• Able to understand and sign the Informed Consent

You may not qualify if:

• Malignant tumors other than T cell malignancies within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
• Uncontrolled infection including bacteral or virus or fugal disease;patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection ;HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive;
• Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening),myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia,liver, kidney, or metabolic disease;
• Any uncontrolled disease may affect entry
• Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology.Patients with a known history or prior diagnosis other immunologic or inflammatory disease affecting the CNS (such as epilepsy)
• Patients who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
• Subjects treated with anti-PD1 or anti-PDL1 therapies within 3months before enrollment
• Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pr egnancy within 1 year after cell transfusion;
• Active or uncontrollable infection requiring systemic therapy Received CAR-T treatment or other gene therapies before enrollment;
• Kown be allergic to anti-TRBC1 CAR-T cells or drugs(Fludarabine or Cyclophophamide)
• The investigators consider other conditions unsuitable for enrollment.
• Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xianmin General Song

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell, Peripheral; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Leukemia; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hematologic Diseases; Lymphoma, Non-Hodgkin; Lymphadenopathy

Study Officials

• Xianmin G Song, M.D.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 22, 2022
• Study Start: May 4, 2022
• Primary Completion: August 1, 2024
• Study Completion: May 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)