Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01626495 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT01626495: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT01626495 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01626495, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
This is a study for children who have been previously treated for Leukemia/Lymphoma. In particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B cells (a type of white cell), which contain the cancer. This is a new approach for treatment of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's white blood cells (T cells) and modify them in order to target the cancer. The subject's T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells the T cells to go to the B cells (tumor cells) and turn "on" and potentially kill the B cells (tumor cells). The modification is a genetic change to the T cells, or gene transfer, in order to allow the modified T cells to recognize your tumor cells but not other normal cells in the subject's body. These modified cells are called chimeric antigen receptor 19 (CART19) T-cells.
Primary Outcome
Inclusive of any events that are "possibly", "likely", or "definitely" related to study treatment any time from the first day of study treatment until week 24.
Interventions
- BIOLOGICAL CART-19
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2011-08-17 |
| Est. Completion | 2019-07-11 |
| Phase | Phase 1 |
What the finished NCT01626495 record still lists
NCT01626495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 1 intervention - of which CART-19 is the first listed.
NCT01626495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01626495 about?
NCT01626495 is a clinical study titled "Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma". This is a study for children who have been previously treated for Leukemia/Lymphoma. In particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B cells (a type of white cell), which contain the cancer. This is a new approach for treatment of Leukemia/Lymphoma that inv...
What is the current status of trial NCT01626495?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2011-08-17. Estimated completion is 2019-07-11.
What interventions are being tested in trial NCT01626495?
The interventions under investigation include: CART-19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01626495?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01626495's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03661307 · 73 participants · Phase 1
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
- NCT05386108 · 73 participants · Phase 1
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
- NCT05961592 · 73 participants · Phase 1
R-2487 in Patients With Rheumatoid Arthritis
- NCT06150664 · 73 participants · Phase 1
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI