Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05398614
Other study ID # SENL101 for CD7+
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 1, 2022
Est. completion date June 30, 2024

Study information

Verified date April 2022
Source Hebei Senlang Biotechnology Inc., Ltd.
Contact Liang Huang
Phone 027-83691785
Email tongjilunli@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.


Description:

Main research purposes: To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies. Secondary research purposes: To preliminarily evaluate the efficacy, pharmacokinetics and pharmacodynamics of SENL101 in the treatment of patients with relapsed or refractory CD7+ hemolymphoid malignancies. Exploratory research purpose: 1. To explore the immunogenicity of SENL101; 2. T cell NK cell recovery time after treatment; 3. Other indicators of interest to researchers。


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility The subjects of this study were patients with recurrent or refractory hematocratic malignancies of CD7+. Inclusion Criteria: 1. Subjects diagnosed with refractory/relapsing T-cell leukaemia/lymphoma met one of the following criteria: relapse: disease recurrence after complete remission with at least two prior regiments or complete remission with stem cell transplantation; Refractory: patients who have received at least two previous treatment regimens and failed to achieve a complete or partial response after the last treatment (leukemia patients), or failed to achieve a response after stem cell transplantation or develop disease progression; 2. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening; 3. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry. If the surface phenotype of peripheral blood tumor cells was not CD4 and CD8 double negative, the proportion of tumor cells in peripheral blood was =1%; 4. Life expectancy greater than 12 weeks; 5. ECOG 0-2; 6. Age 18-65 (upper and lower limits included); 7. HGB at least 70g/L,PLT 20x109/L, can be transfused; 8. Liver and kidney functions The cardiopulmonary functions meet the following requirements: Oxygen saturation under air = 92%; LVEF=45%; Total bilirubin <3×ULN; ALT/AST<5×ULN; Creatinine <1.5×ULN; 9. Informed consent explained to, understood by and signed by patient/ guardian. Exclusion Criteria: Those who meet any of the following criteria are not eligible to join the group: 1. New York Heart Association (NYHA) classification = grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval >480ms at screening (QTc interval calculated by Fridericia formula); 2. If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation; 3. Those with active GvHD or those who require immunosuppressive therapy; 4. Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ; 5. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections); 6. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating medication within the past 2 years; 7. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded; 8. Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer); 9. History of severe allergy to biological products; 10. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy; 11. Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion; 12. Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening; 13. Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
SENL101
Patients will be treated with CD7 CAR-T cells

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Cytokine release Changes from baseline in IFN-?, TNF-a, IL-2, IL-6, IL-10 12 months post CAR-T cells infusion
Other CD7 positive cells in peripheral blood at each time point Absolute value and ratio of CD7 positive cells (T cells NK cells) at each time point in peripheral blood 12 months post CAR-T cells infusion
Other T cell subsets T cell subsets monitoring at each time point (CD4+ CD8+ CD4+/ CD8+ ratio) 12 months post CAR-T cells infusion
Other Immunogenicity endpoint Detectable antibody concentration in serum at each time point 12 months post CAR-T cells infusion
Other T cell NK cell recovery time after treatment Absolute value of T cells NK cells at each time point 12 months post CAR-T cells infusion
Primary Safety: Incidence and severity of adverse events The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period 24 months post CAR-T cells infusion
See also
  Status Clinical Trial Phase
Recruiting NCT05540340 - A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant Phase 1
Completed NCT02158975 - Open-label, Phase II Study of MLN9708 in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas Phase 2
Completed NCT00043368 - PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909) Phase 2
Completed NCT00069238 - Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas Phase 2
Recruiting NCT04104776 - A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas Phase 1/Phase 2
Active, not recruiting NCT03703375 - Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma Phase 3
Recruiting NCT05476770 - Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies Phase 1
Completed NCT00038376 - Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies Phase 2
Recruiting NCT03161223 - Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma Phase 1/Phase 2
Active, not recruiting NCT03902184 - IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma Phase 2
Not yet recruiting NCT03910283 - Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer N/A
Completed NCT04121507 - ASTRAL- a Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy Phase 2
Completed NCT04136275 - CAR-37 T Cells In Hematologic Malignancies Phase 1
Recruiting NCT03921879 - Safety and Efficacy of OT-82 in Participants With Relapsed or Refractory Lymphoma Phase 1
Terminated NCT03154710 - Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response N/A
Recruiting NCT05466318 - ChiCGB vs BEAM in High-risk or R/R Lymphomas Phase 3
Recruiting NCT04928105 - Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma N/A
Withdrawn NCT04233697 - Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma Phase 1
Completed NCT01309789 - A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms Phase 1
Recruiting NCT05557903 - Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL Phase 1