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Recruiting

NCT Number: NCT06698484

To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)

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)

Recruiting

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Key information

Age range

13 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, Malaysia

Location status: Recruiting

Location contact

S Fadilah Abdul Wahid Dr

PRINCIPAL_INVESTIGATOR

S Fadilah Abdul Wahid Dr.

CONTACT

[email protected]

+60391456450

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAR-T cells

Drug

2×10^6 CAR T cells/kg

Primary outcomes

  1. 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

  1. overall survival

    Time frame: OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion

    Overall survival (OS) is defined as the time from the date of CAR-T cell infusion to the date of death from any cause. Patients who are still alive will be censored at the date of last contact.

  2. Incidence of adverse events

    Time frame: From the time of infusion up to 24 months after infusion of CAR-T cells

    Cumulative incidence of CAR-T cell treatment-related adverse events (AEs) graded by ASCT consensus grading criteria for cytokine release syndrome (CRS) and Immune Effector cell-associated Neurotoxicity Syndrome (ICANS) and by common terminology criteria adverse events (CTCAE) versions 5.0 for other AEs in p[articular hematotoxicity and infection.

Study contacts

Contact information is provided by the study sponsor or research team.

S Fadilah Abdul Wahid Dr.

CONTACT

[email protected]

+60391456450

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Collaborators

  • Plutonet Sdn Bhd

Registry information

Official study title

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

Acronym: CAR-T for NHL

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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