Actively Recruiting
CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
Led by KK Women's and Children's Hospital · Updated on 2023-03-09
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
KK Women's and Children's Hospital
Lead Sponsor
S
Singapore General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed or refractory B-lineage leukemia and lymphoma. This phase II, open-label, single-arm, multi-center study focuses on patients who have these specific blood cancers that have either returned or not responded to previous treatments. The study includes several phases: screening for eligibility and enrollment; preparatory steps such as bridging therapy if needed, collection of immune cells through leukapheresis, manufacturing of CAR T-cells, and lymphodepletion treatment; followed by a single infusion of the anti-CD19 CAR T-cells. After treatment, participants will have follow-up visits for up to 24 months to monitor efficacy and safety. Participants will undergo evaluations including disease assessments, safety monitoring, and response measurements over the 24-month follow-up phase. Researchers will track how well the protocol can be followed, the overall response rate within six months, and any treatment-related toxicities. The total study duration includes all phases from screening through extended follow-up, providing detailed monitoring of treatment effects and patient health.
CONDITIONS
Brief Title
CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) with lymphoblasts present or positive minimal residual disease at screening
- Relapsed or refractory B-cell ALL ineligible for hematopoietic stem cell transplantation
- For relapsed B-ALL, documented CD19 tumor expression within 3 months before study entry
- Relapsed or refractory large B-cell lymphoma after at least two lines of systemic therapy, including certain lymphoma subtypes
- Age less than 18 years (pediatric group) or 18 years and older (adult group)
- Adequate organ function
- Life expectancy greater than 12 weeks
- Karnofsky (age ≥16) or Lansky (age <16) performance status of 50 or higher
- Must meet institutional criteria for leukapheresis or have an accepted leukapheresis product
You will not qualify if you...
- B-ALL with isolated extramedullary disease relapse
- Concomitant genetic syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes (Down syndrome allowed)
- Burkitt's lymphoma/leukemia or mature B-cell ALL with specific markers
- Active or latent hepatitis B, active hepatitis C, or uncontrolled infection at screening
- HIV positive within 8 weeks of screening
- Grade 2 to 4 acute or extensive chronic graft-versus-host disease
- Active central nervous system malignancy involvement (CNS-3); treated CNS-2 or history allowed
- Use of investigational medicinal product within 30 days before screening
- Pregnancy or nursing
- Women of childbearing potential and all male participants not using effective contraception for 1 year post-infusion or without negative pregnancy test before infusion
- Prior malignancy except certain treated carcinomas
- Previous gene therapy or anti-CD19/anti-CD3 therapy use (to be discussed with investigator)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Variable duration depending on individual participant's treatment needs
Participants may receive bridging therapy if required, undergo leukapheresis, and have CAR T-cell manufacturing and lymphodepletion before treatment.
Multiple visits for procedures including leukapheresis and lymphodepletion
Duration - Single day for infusion
Participants receive a single infusion of anti-CD19 CAR T-cells as the active treatment.
1 visit (in-person) for infusion
Duration - Up to 24 months
Participants are monitored for efficacy and safety for up to 24 months after treatment.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 2 locations
1
Singapore General Hospital
Singapore, Singapore, 169608
Actively Recruiting
2
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
Research Team
S
Shui Yen Soh, MD
G
Germaine Liew, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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