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New treatment option for T-ALL/Lymphoma
Official title Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies
ClinicalTrials.gov ID: NCT06909474
What this study is testing
What is Anti-CD5 CAR NK cells?
Anti-CD5 CAR NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t-all/lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- \- 1.Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia...
- T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts/immature lymphocytes and/or flow cytometry confirms minimal residual disease...
- 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.
You likely can't join if
- 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.
See the full eligibility 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:
- 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)...
- 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. 3.CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity [MFI] equivalent to normal T...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.