Status:
RECRUITING
Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies
Lead Sponsor:
Chongqing Precision Biotech Co., Ltd
Conditions:
T-ALL/Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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.
Detailed Description
This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of anti-CD5 CAR-NK therapy for the treatment of patients with relapsed/ref...
Eligibility Criteria
Inclusion
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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
- 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.
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06909474
Start Date
March 27 2025
End Date
March 31 2028
Last Update
April 3 2025
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030