Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

National University of Malaysia

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Refractory B Acute Lymphoblastic Leukaemia; Relapsed B Acute Lymphoblastic Leukaemia

Treatments: Biological: CD19 CAR-T CELLS; Drug: Fludarabine; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03937544

FF-2019-138 (Other Identifier)

JEP-2019-003

Details and patient eligibility

About

This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia

Enrollment: 10 estimated patients

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics
• Age between ≥13 to ≤ 65 years
• No detectable leukaemia in the CSF (CNS-1)
• CNS leukaemia without clinically evident neurological symptoms (CNS-2; with <5 WBC per μL and cytology positive for blasts)
• Adequate organ function as defined by a creatinine clearance > 50 ml/min, serum total bilirubin < 5 times the normal value, left ventricular ejection fraction > 40%
• ECOG performance status ≤ 2
• Life expectancy > 3 months
• Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression
• Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods
• Male patients must use highly effective contraception methods

Exclusion criteria

• Patients with CNS-3 leukaemia.
• Active cancer (other than B-ALL).
• Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder.
• Presence of active autoimmune disease or atopic allergy.
• HIV serology positivity.
• Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.
• Uncontrolled sepsis
• Pregnant / nursing female.
• Ongoing prednisolone > 1mg/kg daily or equivalent.
• Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CD19 CAR-T CELLS

Experimental group

Description:

A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.

Treatment:

Drug: Cyclophosphamide

Drug: Fludarabine

Biological: CD19 CAR-T CELLS