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

NCT06698484 | Recruiting Phase 2 DMC

• 2 other identifiers: CAR-T NHL PTS Plutonet 2021JEP-2021-224
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma

Keywords

RR B- NHL; CD19 CAR-T cells; malaysia

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  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.

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

Secondary Outcomes (2)

• 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

Study Arms (1)

Patient will infuse with autologous CD19 CAR-T cells

EXPERIMENTAL

CD19 CAR-T cells

Drug: CAR-T cells

Interventions

CAR-T cells DRUG

2×10\^6 CAR T cells/kg

Patient will infuse with autologous CD19 CAR-T cells

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead
• Plutonet Sdn Bhd: collaborator

Study Sites (1)

Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, Malaysia

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

S Fadilah Abdul Wahid Dr.

CONTACT

+60391456450; sfadilah@hctm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 21, 2024
• Study Start: June 3, 2021
• Primary Completion: June 2, 2025
• Study Completion (Estimated): June 2, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)