Actively Recruiting
Open-label, Dose-escalation Phase 1 Study of SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory T-LBL/ALL
Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2023-11-18
9
Participants Needed
1
Research Sites
730 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the tolerability and safety of SENL101, a CAR-T immunotherapy targeting CD7+, in adults with relapsed or refractory T-lymphoblastic lymphoma (T-LBL) or T-cell acute lymphoblastic leukemia (T-ALL). This Phase 1 open-label study also aims to preliminarily assess the efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and recovery of T and NK cells following treatment. The study involves a dose-escalation design where participants receive SENL101 autologous T cell injections. The treatment targets CD7-positive tumor cells detected by bone marrow flow cytometry or immunohistochemistry of extramedullary lesions. Participants must meet specific health and organ function criteria before receiving the infusion. During the trial, researchers will monitor participants for safety by tracking the incidence and severity of adverse events for 28 days after infusion. Additional assessments include blood tests, organ function evaluations, and immunological monitoring to understand the therapy's effects and recovery times. The study will continue to follow participants until August 2038, with ongoing evaluations as indicated by the protocol.
CONDITIONS
Brief Title
CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with refractory or relapsing T-lymphoblastic lymphoma or T-cell acute lymphoblastic leukemia as per WHO classification
- Experienced relapse or refractory disease after standard treatments or stem cell transplantation
- Tumor cells are CD7-positive by bone marrow flow cytometry or immunohistochemistry
- If tumor cells are in peripheral blood, they are CD4 and CD8 double negative
- Life expectancy greater than 12 weeks
- ECOG performance status between 0 and 2
- Age between 18 and 75 years inclusive
- Hemoglobin at least 70 g/L and platelet count at least 50 x 10^9/L (can be transfused)
- Adequate liver, kidney, and cardiopulmonary functions meeting specified limits
- Provided informed consent understood and signed by patient or guardian
You will not qualify if you...
- NYHA class III or higher heart failure or recent major cardiac events within one year
- Less than 6 months since allogeneic hematopoietic stem cell transplantation
- Active graft-versus-host disease or need for immunosuppressive therapy
- Other malignancies within 5 years except certain treated cancers
- History of serious central nervous system diseases
- Active or uncontrolled infections requiring systemic treatment within 7 days
- Autoimmune diseases requiring systemic immunosuppressive treatment within past 2 years
- Positive active infections for hepatitis B, hepatitis C, HIV, CMV, or syphilis
- Participation in other clinical trials within 4 weeks or recent drug use within 5 half-lives
- Severe allergy to biological products
- Unstable severe liver, kidney, or metabolic disease
- Pregnant or breastfeeding women or planning pregnancy within 2 years
- Prior CAR-T or gene-modified cell therapy
- Any condition increasing risk or interfering with trial results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after infusion
Participants receive SENL101 CAR-T immunotherapy targeting CD7+ cells.
1 infusion visit and multiple follow-up visits within 28 days
Trial Site Locations
Total: 1 location
1
Shanghai Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
W
Weili Zhao, Dr
L
Liang Huang, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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