Trials / Unknown
UnknownNCT04653493
CD19 Targeted CAR T Cell Therapy in Patients With Relapsed/ Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
Phase I Clinical Trial Evaluating Safety of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- Sponsor
- Sabz Biomedicals · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm, open-label, phase I study (safety and dose escalation) of autologous Chimeric Antigen Receptor (CAR) T-cells targeting CD19 in patients with relapsed/refractory B cell acute lymphoblastic leukemia (ALL).
Detailed description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, pediatric or adolescent/young adult patients with CD19+ relapsed or refractory B cell acute lymphoblastic leukemia (R/R B-ALL) will be enrolled. Eligible patients will receive CAR T product intravenously as a single or split dose following pre-conditioning by a lymphodepleting chemotherapeutic regimen and will then enter a 30-day follow-up period to monitor adverse events using the NCI CTCAE (version 5.0).
Conditions
- Relapsed B Cell Acute Lymphoblastic Leukemia (ALL)
- Refractory B Cell Acute Lymphoblastic Leukemia (ALL)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 CAR engineered autologous T-cells | Given IV Following preconditioning with lymphodepleting chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) T cells as a single or split dose (day 0, 1 and 2, CAR cells will be intravenously infused at the 10%, 30% and 60% ratio respectively). Dosing of CD19 CAR-T cells will follow a dose-escalation schema, with dose changes based on dose-limiting toxicities. |
| DRUG | Cyclophosphamide | Given IV |
| DRUG | Fludarabine | Given IV |
| DRUG | Mesna | Given IV |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2024-08-01
- Completion
- 2024-08-01
- First posted
- 2020-12-04
- Last updated
- 2021-03-19
Locations
2 sites across 1 country: Iran
Source: ClinicalTrials.gov record NCT04653493. Inclusion in this directory is not an endorsement.