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

Launched by CHONGQING PRECISION BIOTECH CO., LTD · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called CD5-targeted CAR-NK therapy for patients with certain types of relapsed or hard-to-treat T-cell cancers, specifically T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma. The goal of the study is to see if this therapy is safe and effective in helping these patients. If you or a loved one is between the ages of 18 and 75 and has been diagnosed with one of these conditions, you might be eligible to participate. To qualify, patients typically need to have had previous treatments that didn't work or have relapsed after their initial treatment.

Participants in the trial will undergo a procedure to collect their immune cells, which will then be modified in the lab to better fight the cancer. After this, they will receive the modified cells back into their body. Throughout the trial, participants will be closely monitored for any side effects and the overall effectiveness of the treatment. It's important to note that there are certain health criteria that must be met to join, and patients will need to provide informed consent, meaning they will understand the study and agree to take part. This trial is currently recruiting participants, and it offers a potential new option for those with limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -
• 1.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:
• 1. 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:
• • 1. Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR).
• • 2. Relapsed within 12 months after achieving CR with first-line induction therapy.
• • 3. Failure to achieve CR or relapse after ≥2 lines of chemotherapy.
• • 4. Relapse after hematopoietic stem cell transplantation (HSCT).
• 2. 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:
• • 1. 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.
• • 2. Refractory to ≥2 lines of chemotherapy, primary resistance, or relapse post-HSCT.
• • 3.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).
• 4.ECOG Performance Status: 0-2 . 5.Life Expectancy: ≥12 weeks. 6.Organ Function:
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• • 1. Cardiac: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no significant ECG abnormalities.
• • 2. Renal: Serum creatinine ≤2.0×ULN.
• • 3. Hepatic: ALT/AST ≤3.0×ULN (≤5.0×ULN if liver involvement); total bilirubin ≤2.0×ULN.
• • 4. 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).
• • 10.Informed Consent: Signed by the patient or legal guardian, confirming understanding of the trial's purpose and procedures.
• Exclusion Criteria:
• • 1. Prior CAR-NK therapy or genetically modified cell therapy.
• • 2. Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).
• 3. Recent Anticancer Therapy:
• • 1. Chemotherapy, targeted therapy, or investigational drugs within 2 weeks or 5 half-lives prior to screening.
• • 2. Radiotherapy within 2 weeks prior to screening.
• • 4. Active/Uncontrolled Infection: Within 1 week prior to screening.
• • 5. Cerebrovascular Event or Seizure: Within 6 months prior to screening.
• 6. Viral Infections:
• • 1. HBV DNA \> ULN (if HBsAg+ or HBcAb+).
• • 2. HCV RNA \> ULN (if HCV Ab+).
• • 3. HIV+, syphilis+, or active tuberculosis.
• 7. Cardiac Disease:
• • 1. NYHA Class III/IV congestive heart failure.
• • 2. Myocardial infarction or CABG ≤6 months prior.
• • 3. Clinically significant ventricular arrhythmia or unexplained syncope (excluding vasovagal/dehydration-related).
• • 4. Severe cardiomyopathy.
• • 8. Active/Uncontrolled Autoimmune Disease.
• • 9. Prior Malignancy: Within 5 years, except for cured cervical carcinoma in situ, basal/squamous skin cancer, localized prostate cancer, or ductal carcinoma in situ.
• • 10. Live Vaccination: Within 4 weeks prior to screening.
• • 11. Pregnancy/Lactation: Pregnant, breastfeeding, or planning pregnancy within 1 year post-CAR-NK infusion.
• • 12. Other: Investigator-determined ineligibility.