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Chemotherapy

iC9/CAR.19/IL15-Transduced CB-NK Cells for B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Loretta Nastoupil, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days
Awards & highlights

Study Summary

This trial is for people with B-cell lymphoma or leukemia who have relapsed or are refractory to treatment. The study will test if giving CAR-NK cells after chemotherapy will improve the disease.

Eligible Conditions
  • B-Cell Lymphoma
  • Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Chimeric Antigen Receptors (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood Natural Killer (CB-NK) Cells in Patients with Relapsed/Refractory CD19+ B Lymphoid Malignancies
Optimal NK Cell Dose Level of Chimeric Antigen Receptors (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood Natural Killer (CB-NK) Cells in Patients with Relapsed/Refractory CD19+ B Lymphoid Malignancies
Toxicity of Chimeric Antigen Receptors (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood Natural Liller (CB-NK) Cells in Patients with Relapsed/Refractory CD19+ B Lymphoid Malignancies
Secondary outcome measures
Response of Chimeric Antigen Receptors (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood Natural Killer (CB-NK) Cells in Patients with Relapsed/Refractory CD19+ B Lymphoid Malignancies

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fludarabine + Cyclophosphamide + CAR-NK CellsExperimental Treatment5 Interventions
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose. On Day 0, participants receive genetically modified NK cells as a cell infusion. If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Mesna
2003
Completed Phase 2
~1380
Fludarabine
2012
Completed Phase 3
~1090
AP1903
2014
Completed Phase 2
~80
iC9/CAR.19/IL15-Transduced CB-NK Cells
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,405 Total Patients Enrolled
Loretta Nastoupil, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants actively being added to this investigation?

"Despite initial posting in June 21st 2017, the information on clinicaltrials.gov shows that this specific trial is no longer enlisting patients. Nevertheless, there are over 5000 other studies actively researching new recruits at present."

Answered by AI

In what ways is iC9/CAR.19/IL15-Transduced CB-NK Cells being utilized therapeutically?

"iC9/CAR.19/IL15-Transduced CB-NK Cells are a viable therapeutic option for multiple sclerosis, Acute Leukemia, Myelocytic Leukemia and Retinoblastoma."

Answered by AI

Does the age criterion for this research protocol include individuals under 45 years of age?

"To be included in this study, patients must meet the age requirement of between 7 to 80 years old. There are 1110 studies available for those younger than 18 and 4370 studies open to seniors 65 and over."

Answered by AI

To whom is this test protocol open?

"This clinical trial seeks 36 individuals with chronic B-cell leukemia, lymphocytic leukemia and other related conditions between the ages of 7 to 80. Applicants must be 3 weeks removed from their last cytotoxic chemotherapy session before beginning lymphodepleting chemotherapy, as well as maintain a Karnofsky/Lansky Performance Scale score higher than 70. Furthermore, all participants who are able to have children must practice adequate contraception for the duration of the study; males should use condoms with spermicide or abstain while females can opt for hormonal birth control methods such as intrauterine devices or diaphragms with spermicides."

Answered by AI

What is the uppermost limit for participation in this experiment?

"This clinical trial is not currently enrolling participants. It was first posted on June 21st 2017, and the last update was August 1st 2022. If you are searching for alternative studies, there are 4170 trials recruiting patients with leukemia, lymphocytic/chronic B-cell, as well as 924 trails seeking iC9/CAR 19/IL15 Transduced CB-NK Cells patient participation."

Answered by AI

Are there any previous reports of iC9/CAR.19/IL15-Transduced CB-NK Cells being used for research purposes?

"Currently, there are 161 Phase 3 clinical trials and 924 live studies for iC9/CAR.19/IL15-Transduced CB-NK Cells scattered across 28576 locations in the United States with Philadelphia being a major research hub."

Answered by AI
~6 spots leftby Mar 2025