BridgeMD
New treatment option for Refractory/Recurrent Peripheral T-cell Lymphoma
Official title Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
ClinicalTrials.gov ID: NCT07164560
What this study is testing
What is Anti-TRBC1 CAR-T cells?
Anti-TRBC1 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory/recurrent peripheral t-cell 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 study aims to evaluate the safety and efficacy of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 (TRBC1/2 CAR-NK cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL).
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
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
- According to the 2016 WHO classification of lymphoid neoplasms, patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) must meet the...
- Voluntarily agree to participate in this study and provide signed informed consent.
- Age 18 to 75 years, male or female.
- Diagnosis of relapsed/refractory PTCL, defined as failure of ≥1 prior line of therapy. Eligible histologic subtypes include (but are not limited to)...
- Estimated life expectancy ≥12 weeks.
You likely can't join if
- Patients meeting any of the following criteria will be excluded from this study:
- History of allergy to any component of the cell product.
- History of another malignancy that has not achieved remission.
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Receipt of gene therapy within the past 3 months.
- Uncontrolled systemic active infection (with the exception of simple urinary tract infection or bacterial pharyngitis). Prophylactic use of...
See the full eligibility criteria
- According to the 2016 WHO classification of lymphoid neoplasms, patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) must meet the following criteria to be eligible for enrollment:
- Voluntarily agree to participate in this study and provide signed informed consent.
- Age 18 to 75 years, male or female.
- Diagnosis of relapsed/refractory PTCL, defined as failure of ≥1 prior line of therapy. Eligible histologic subtypes include (but are not limited to): Angioimmunoblastic T-cell lymphoma (AITL) Anaplastic large cell...
- Estimated life expectancy ≥12 weeks.
- TRBC1/2-positive tumor tissue (≥20% by immunohistochemistry) OR TCR gene rearrangement confirmed by PCR or NGS.
- ECOG performance status of 0-2.
- Adequate organ function as defined below: ALT and AST ≤ 2.5 × upper limit of normal (ULN) Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min Total bilirubin ≤ 1.5 × ULN Left ventricular ejection fraction (LVEF) ≥ 50%...
- ≥3 months since prior autologous hematopoietic stem cell transplantation.
- Prior CAR-NK therapy targeting a different antigen is permitted if lack of how well it works was confirmed after ≥3 months of evaluation, or if complete remission (CR) was achieved but relapse occurred.
- Women of childbearing potential must have a negative pregnancy test prior to enrollment. All patients (male and female) must agree to use effective contraception during the study.
- Presence of at least one measurable lesion.
- All approved prior anti-tumor therapies (including systemic chemotherapy, total body irradiation, or immunotherapy) must have been completed ≥3 weeks before study drug administration; for non-chemotherapy targeted...
- Patients meeting any of the following criteria will be excluded from this study:
- History of allergy to any component of the cell product.
- History of another malignancy that has not achieved remission.
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Receipt of gene therapy within the past 3 months.
- Uncontrolled systemic active infection (with the exception of simple urinary tract infection or bacterial pharyngitis). Prophylactic use of antibiotics, antivirals, or antifungal agents is permitted.
- Active hepatitis B infection (HBsAg positive; however, patients with HBV-DNA \<10³ copies/mL are not excluded), active hepatitis C virus infection (including carriers), syphilis, or other acquired or congenital...
- New York Heart Association (NYHA) Class III or IV heart failure.
- Unresolved toxicity from prior anti-tumor therapy (defined as CTCAE v5.0 Grade \>1, with the exception of fatigue, anorexia, and alopecia).
- Evidence of central nervous system (CNS) involvement at screening, or clinically significant CNS disease such as a history of seizures or other CNS disorders.
- Prior exposure to any agent specifically targeting TRBC1/2.
- Lactating women who are unwilling to discontinue breastfeeding.
- Any other condition that, in the opinion of the investigator, may increase patient risk or interfere with the study results.
- People who test positive for COVID-19 or influenza A virus.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Hangzhou, Zhejiang, 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.