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

• Status: Recruiting
• Trial end date: 2024-03-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University of Malaysia
• Collaborators: Gaia Science; GAIA Sdn Bhd
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

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.