CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
Launched by KK WOMEN'S AND CHILDREN'S HOSPITAL · Dec 4, 2022
Trial Information
Current as of February 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called CD19-directed CAR T-cell therapy for patients with certain types of blood cancers, specifically B-lineage leukaemia and lymphoma that have come back or did not respond to previous treatments. The goal is to see how feasible it is to create and give this therapy right at the point of care for patients. It is open to individuals of all ages, from children to adults, who have specific types of relapsed or refractory B-cell acute lymphoblastic leukaemia or large B-cell lymphoma.
To be eligible for this trial, patients must have a documented diagnosis that meets certain criteria, such as the presence of cancer cells in their bone marrow or blood and must have had multiple treatments already. They should also be in good overall health with a life expectancy of at least 12 weeks. Participants can expect to undergo a procedure called leukapheresis, where their blood is collected to extract immune cells that will be modified in the lab before being given back to them. It’s important to note that there are some conditions and health issues that would exclude a patient from participating, so discussing personal health history with the medical team is vital. This trial aims to offer hope for patients facing challenging forms of cancer by exploring innovative treatment options.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- 1. Eligible disease conditions:
- • 1. Relapsed or refractory B-cell ALL (all must be satisfied)
- • Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.
- • Relapsed or refractory or ineligible for HSCT
- • For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry
- • 2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
- 2. Age at screening:
- • 1. \< 18 years (paediatric group); or
- • 2. ≥ 18 years (adult group)
- 3. Adequate organ functions:
- • 4. Life expectancy more than 12 weeks.
- • 5. Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening.
- • 6. Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.
- Exclusion Criteria:
- Patients with any of the following will be excluded:
- • B-ALL with isolated extramedullary disease relapse
- • Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
- • Patients with Burkitt's lymphoma/leukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation)
- • Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- • Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening
- • Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)
- • Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.
- • Patient has an investigational medicinal product within the last 30 days prior to screening.
- • Pregnant or nursing women.
- • Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.
- The following are not strictly exclusion criteria but must be discussed with PI/Site-PI:
- • Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
- • Treatment with any prior gene therapy product
- • Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
Trial Officials
Shui Yen Soh, MD
Principal Investigator
KK Women's and Children's Hospital
Aloysius Ho, MD
Principal Investigator
Singapore General Hospital
About Kk Women's And Children's Hospital
KK Women’s and Children’s Hospital is a leading healthcare institution dedicated to providing comprehensive medical services for women and children. As a prominent clinical trial sponsor, the hospital is committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on maternal and child health, KK Women’s and Children’s Hospital collaborates with multidisciplinary teams of experts to conduct rigorous clinical trials that adhere to the highest ethical standards. Their mission is to enhance the quality of care through evidence-based practices, fostering a healthier future for families in the community and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Singapore, , Singapore
Singapore, , Singapore
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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