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Clinical Trials/NCT06698484
NCT06698484RecruitingPhase 2

A Phase II Open Label Single-arm Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T Cells in Patients With Relapsed/Refractory B- Non-Hodgkin Lymphoma

National University of Malaysia1 site in 1 country20 target enrollmentStarted: June 3, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Overall response rate (ORR)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification
  • •Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT
  • •At least one measurable lesion according to revised IWG response criteria
  • •Age between ≥13to ≤75 years
  • •Adequate organ function as defined by a creatinine clearance >40 ml/min, serum alanine transaminase (ALT) < 5 times the normal value, serum bilirubin < 3 times the normal value, left ventricular ejection fraction> 45%
  • •Absolute neutrophil count ≥ 1500/μl, haemoglobin level ≥ 7 g/dl, platelets ≥ 50000/μl.
  • •Life expectancy >12 weeks
  • •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • •Female of childbearing age must have a negative pregnancy test and is on two effective contraception methods
  • •Male patients must use two effective contraception methods

Exclusion Criteria

  • •Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis)
  • •Active cancer(other than NHL) or receiving cancer treatment
  • •Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder
  • •Presence of active autoimmune disease requiring immunosuppressive therapy
  • •Human Immunodeficiency Virus (HIV) positivity
  • •Active Hepatitis B, and Hepatitis C infection
  • •Uncontrolled infection
  • •Pregnant/nursing female.
  • •Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrolment

Arms & Interventions

Patient will infuse with autologous CD19 CAR-T cells

Experimental

CD19 CAR-T cells

Intervention: CAR-T cells (Drug)

Outcomes

Primary Outcomes

Overall response rate (ORR)

Time Frame: From day 30, then 3 monthly until 24 months after infusion of CAR-T cells

The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL). Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study.

Secondary Outcomes

  • overall survival(OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion)
  • Incidence of adverse events(From the time of infusion up to 24 months after infusion of CAR-T cells)

Investigators

Sponsor
National University of Malaysia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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