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RecruitingPhase 1NCT06909474

Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies

Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/Refractory T-Cell Hematologic Malignancies

Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

15 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

T-ALL/Lymphoma

Summary

This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria18

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  • Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma, including:
  • T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts/immature lymphocytes and/or flow cytometry confirms minimal residual disease (MRD)+, and meets any of the following:
  • Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR).
  • Relapsed within 12 months after achieving CR with first-line induction therapy.
  • Failure to achieve CR or relapse after ≥2 lines of chemotherapy.
  • Relapse after hematopoietic stem cell transplantation (HSCT).
  • T-cell Lymphoma Patients: Confirmed diagnosis of T-lymphoblastic lymphoma (T-LBL) or T-cell non-Hodgkin lymphoma (including but not limited to: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), extranodal NK/T-cell lymphoma (ENKL), T-cell prolymphocytic leukemia (T-PLL), adult T-cell leukemia/lymphoma (ATLL), mycosis fungoides/Sézary syndrome (MF/SS) stage IIB or higher), and meets both:
  • At least one bidimensionally measurable lesion per Lugano 2014 criteria: nodal lesions \>1.5 cm in long axis; extranodal lesions \>1.0 cm in long axis.
  • Refractory to ≥2 lines of chemotherapy, primary resistance, or relapse post-HSCT.
  • CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity \[MFI\] equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) or immunohistochemistry (\>30% tumor cells express CD5).
  • ECOG Performance Status: 0-2 . 5.Life Expectancy: ≥12 weeks. 6.Organ Function:
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  • Cardiac: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no significant ECG abnormalities.
  • Renal: Serum creatinine ≤2.0×ULN.
  • Hepatic: ALT/AST ≤3.0×ULN (≤5.0×ULN if liver involvement); total bilirubin ≤2.0×ULN.
  • Pulmonary: Oxygen saturation ≥92% (room air). 7.No Contraindications: To leukapheresis, venipuncture, or cell collection. 8.No Severe Psychiatric Disorders. 9.Contraception: Agreement to use effective contraception from informed consent until 1 year post-CAR-NK infusion (for patients of childbearing potential).
  • Informed Consent: Signed by the patient or legal guardian, confirming understanding of the trial's purpose and procedures.

Exclusion Criteria21

  • Prior CAR-NK therapy or genetically modified cell therapy.
  • Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).
  • Recent Anticancer Therapy:
  • Chemotherapy, targeted therapy, or investigational drugs within 2 weeks or 5 half-lives prior to screening.
  • Radiotherapy within 2 weeks prior to screening.
  • Active/Uncontrolled Infection: Within 1 week prior to screening.
  • Cerebrovascular Event or Seizure: Within 6 months prior to screening.
  • Viral Infections:
  • HBV DNA \> ULN (if HBsAg+ or HBcAb+).
  • HCV RNA \> ULN (if HCV Ab+).
  • HIV+, syphilis+, or active tuberculosis.
  • Cardiac Disease:
  • NYHA Class III/IV congestive heart failure.
  • Myocardial infarction or CABG ≤6 months prior.
  • Clinically significant ventricular arrhythmia or unexplained syncope (excluding vasovagal/dehydration-related).
  • Severe cardiomyopathy.
  • Active/Uncontrolled Autoimmune Disease.
  • Prior Malignancy: Within 5 years, except for cured cervical carcinoma in situ, basal/squamous skin cancer, localized prostate cancer, or ductal carcinoma in situ.
  • Live Vaccination: Within 4 weeks prior to screening.
  • Pregnancy/Lactation: Pregnant, breastfeeding, or planning pregnancy within 1 year post-CAR-NK infusion.
  • Other: Investigator-determined ineligibility.

Interventions

BIOLOGICALAnti-CD5 CAR NK cells

Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.

Locations(1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

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