Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

NCT04173988

ALL, Childhood B-Cell

ACTIVE_NOT_RECRUITING EARLY_PHASE1

A Phase II Study on Allogeneic Stem Cell Transplantation in Patients With Active Acute Leukemia

NCT01814488

Acute Leukemia

COMPLETED PHASE2

Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

NCT03207191

Acute Myeloid Leukemia (AML) Relapse

COMPLETED PHASE1

A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia

NCT01701375

Relapsed Acute Leukemia Refractory Acute Leukemia High-Risk Myelodysplasia

TERMINATED PHASE1

Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia

NCT00337519

Chronic Lymphocytic Leukemia

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia, in Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CARCIK-CD19

Group Type EXPERIMENTAL

CARCIK-CD19

Intervention Type BIOLOGICAL

Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CARCIK-CD19

Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children (1-17) and adults (18-75 years old);
* Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
* Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
* No evidence of overall aGVHD \> Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
* No longer taking immunosuppressive agents for at least 30 days prior to enrollment;