NCT06635330RecruitingPhase 1/2
Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
A Phase I/II Single Arm Study, Safety and Efficacy Assessment of the CD19 CAR T Cell on Pediatric Patients with Relapsing or Refractory B Cell Acute Lymphoblastic Leukemia (r/r B-ALL)
Source: ClinicalTrials.gov · Last updated 10 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following: 1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)? 2. What is the rate of Event-free survival at first month and 2-3 months after intervention? 3. What is the rate of Overall survival at first month and at 3 months after the intervention?
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 1 Oct 2024
- Start date
- 20 May 2024
- Primary completion date
- 22 Sept 2026
- Lead sponsor
- Kara Yakhteh Tajhiz Azma Company
- NCT number
- NCT06635330
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 5
- From 20 May 2024 to the primary completion date, 22 Sept 2026
- 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiation therapy within last 14 days
Other illness
- Presence of active malignancy other than the disease under study
- Any CNS disorder
- History of Anti-CD19 or Anti-CD20 therapy
- Presence of severe active infection
Lab values
- Donor lymphocyte injection or other cell therapy methods within the last 30 days
Other
- Chloroma and leukemic infiltration on MRI or significant neurological symptoms
- Presence of active GVHD
- Organ dysfunction
Who the study is looking for
- Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL
- Presence of disease in the bone marrow
- Able to tolerate the apheresis process
- Life expectancy \> 12 weeks
- Lansky or Karnofsky score \> 50%
- At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids
- Informed consent
- Having potential donor for stem cell transplantation
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pediatric cell and gene therapy research center, Children medical center Coordinator of this site? Confirm its status | Tehran | Iran | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.