Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
Recruiting
Phase 2
Phase 3
Interventional Study
Relapsed B Acute Lymphoblastic Leukaemia
Refractory B Acute Lymphoblastic Leukaemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 13 – 65
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- National University of Malaysia · Other
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About This Trial
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
Trial Locations
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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 leukaemi…
Contacts