Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies

NCT06462248 | Recruiting Phase 2

• 1 other identifier: CU2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.

Conditions

Lymphoma, Nonhodgkin; Leukemia, Lymphocytic

Keywords

relapsed leukemia; relapsed B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Production efficiency of CAR-T cell manufacturing

  At least 90% of patients enrolled should be able to achieve successful production of CAR T cells as deomonstrated by CAR-T cell proliferation and persisteance of CAR-T cells in recipients for at least one month after infusion

  18 months

Secondary Outcomes (1)

• survival outcome

  24 months

Study Arms (1)

single arm

EXPERIMENTAL

Single arm open labelled phase 2 study

Drug: CUCART19

Interventions

CUCART19 DRUG

anti-CD19 chimeric antigen receptor modified T-cell (CAR-T)

Also known as: anti-CD19 CAR-T

single arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Lymphoblastic Leukaemia
• Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or relapse after prior stem cell transplant, or persistent Minimal Residual Disease (MRD) positive disease
• ECOG performance score of ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening
• Post allogeneic stem cell transplant patients with B cell ALL will be eligible \> 3 months after transplant and off immunosuppression for at least 1 month.
• Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,
• For women of childbearing potential, a negative pregnancy test prior to apheresis
• B-cell lymphoma
• Patients with histologically confirmed refractory Diffuse Large B-cell Lymphoma, primary mediastinal B cell lymphoma or transformed follicular lymphoma or other B-cell lymphoma according to WHO classification
• Confirmed CD19 positivity status in tissue sample obtained at diagnosis or relapse
• Received at least two prior treatment which must include at least one intensive systemic therapy.
• Disease progression or relapsed disease within 12 months after autologous stem cell transplant
• ECOG performance score of ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening
• Has sufficient organ function to tolerate treatment with CAR-T cell therapy
• For women of childbearing potential, a negative pregnancy test prior to apheresis

You may not qualify if:

• Patients with active infection
• Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression
• Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion
• Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
• Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage, dementia, paralysis)
• Patients who are positive for HBsAg, HCV RNA positive or with HIV infection
• Pulmonary function: Grade 1 dyspnea and pulse oxygenation \> 91% on room air
• Cardiac function: Fractional shortening \<28% or left ventricular ejection fraction \<45% by echocardiography.
• Renal function: Creatinine clearance \<50 mL/min/1.73 m2
• Liver function: Patients with a serum bilirubin \>3 times upper limit of normal or an AST or ALT \> 5 times upper limit of normal, unless due to leukaemic liver infiltration in the estimation of the investigator
• Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy.

Sponsors & Collaborators

• Chi Kong Li: lead
• Hong Kong Children's Hospital: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Chi Kong Li, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Kong Li, MD

CONTACT

852-35051019; ckli@cuhk.edu.hk

Yvonne Chu, MD

CONTACT

852-35051019; yvonnechu@cuhk.edu.hk

Study Design

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

Model Details: single arm prospective study

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 17, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)