NCT03937544RecruitingPhase 2/3
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
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
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 22 Apr 2019
- Start date
- 19 Mar 2019
- Primary completion date
- 18 Jan 2027
- Lead sponsor
- National University of Malaysia
- NCT number
- NCT03937544
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 10
- From 19 Mar 2019 to the primary completion date, 18 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.
Other illness
- 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.
Other
- Patients with CNS-3 leukaemia.
- Uncontrolled sepsis
- Pregnant / nursing female.
- Ongoing prednisolone > 1mg/kg daily or equivalent.
Who the study is looking for
- 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
Age in the registry: 13 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UKM Medical Centre Coordinator of this site? Confirm its status | Bandar Tun Razak | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.