Clinical trial NCT03937544: Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
Official title: A Phase II/III Prospective, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed/ Refractory B-Acute Lymphoblastic Leukaemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Relapsed B Acute Lymphoblastic Leukaemia
Refractory B Acute Lymphoblastic Leukaemia
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Gaia Science
First posted: 2019-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Participants will be followed for the duration of the treatment, with an expected average of 3 months.
measure: Complete response (CR)
timeFrame: 12 Months
measure: CR with incomplete blood recovery (CRi).
timeFrame: 12 Months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 12 Months, 24 Months
measure: Progression free survival (PFS)
timeFrame: 12 Months, 24 Months
measure: Time to next treatment (TTNT)
timeFrame: 12 Months, 24 Months
measure: Percentage of adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Bandar Tun Razak
country: Malaysia
facility: UKM Medical Centre
state: Kuala Lumpur
Study officials:
References: