iC9-CAR19 cells for Immune System Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, NC
Immune System Diseases+5 More
iC9-CAR19 cells - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL

See full description

Eligible Conditions

  • Immune System Diseases
  • Immunoproliferative Disorders
  • Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Immune System Diseases

Study Objectives

This trial is evaluating whether iC9-CAR19 cells will improve 1 primary outcome and 11 secondary outcomes in patients with Immune System Diseases. Measurement will happen over the course of 4 weeks.

15 years
Changes in patient reported health-related quality of life in adult patients
Changes in patient reported physical functions in adult patients
Changes in persistence of iC9-CAR19 T cells in vivo
Event-free survival rate
Incidence of patient reported symptoms in adult patients using selected symptoms from the NCI PRO-CTCAE
Overall Response Rate (ORR)
Overall survival after infusion of iC9-CAR19 T cells
Relapse-free survival rate
4 weeks
Incidence of dose limiting toxicity to identify recommended phase 2 dose (RP2D)
Number of participants with adverse events as a measure of safety and tolerability of a second infusion of iC9-CAR19 T cells
Number of participants with adverse events as a measure of safety and tolerability of iC9-CAR19 T cells
8 weeks
Rate of measurable residual disease (MRD) clearance in subjects who receive iC9-CAR19 T cells for MRD persistence or MRD-only relapse

Trial Safety

Safety Progress

1 of 3

Other trials for Immune System Diseases

Trial Design

2 Treatment Groups

iC9-CAR19 cells
1 of 2
Expansion Cohort Second Administration of iC9-CAR19 cells
1 of 2
Experimental Treatment

This trial requires 54 total participants across 2 different treatment groups

This trial involves 2 different treatments. IC9-CAR19 Cells is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

iC9-CAR19 cellsThe 3+3 design in adult subjects and an independent study using 3+3 design in pediatric subjects. The starting dose of 5 x 10^5 transduced cells/kg will enroll 3 adult subjects in the initial cohort. If there are no dose limiting toxicities w/in 4 weeks of the cell infusion in these 3 subjects, then the next cohort will evaluate 1 x10^6 transduced cells/kg in adults. If there is toxicity in 1/3 patients in the initial cohort, the cohort will be expanded to enroll up to 6 adult patients. If the dose level 1 is determined to be above the tolerated cell dose, de-escalation would occur to dose level -1 where subjects would receive 1 x 10^5 transduced cells/kg. All subjects will receive a lymphodepleting regimen of fludarabine and cyclophosphamide before administration of iC9-CAR19 T cells.
Expansion Cohort Second Administration of iC9-CAR19 cellsAfter the recommended phase 2 dose (RP2D) of iC9-CAR19 T cells has been determined in adults, up to 18 additional adult subjects will be enrolled in an expansion cohort at the RP2D. In the expansion cohort, subjects will be offered a second infusion of iC9-CAR19 T cells based on B-cell recovery and minimal residual disease (MRD) status. All subjects will receive a lymphodepleting regimen of fludarabine and cyclophosphamide before second administration of iC9-CAR19 T cells. Subjects in the expansion cohort who experience ≥grade 2 CRS or ICANS, did not respond to the initial dose of the standard of care treatment will be enrolled in a sub-study of rimiducid.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Rimiducid
Not yet FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 15 years for reporting.

Closest Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Immune System Diseases or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All clinical and laboratory data required for determining eligibility must be available in the subject's medical/research record which will serve as the source document. Subjects may be transfused with blood products to obtain a hemoglobin level > 7.0 g/dL and platelet count > 20,000 per μl.
Note: During the period after cell procurement and during iC9-CAR19 T-cell production, subjects are allowed to receive standard of care intervening therapy for ALL to manage their disease if the treating physician feels it is in the subject's best interest Common Inclusion Criteria for all subjects
Written informed consent for procurement signed by subject or legal guardian of a pediatric subject and HIPAA authorization
Age 3 to 17 years of age for pediatric subjects (weight must be ≥10 kg), ≥ 18 to 70 years of age for adults at the time of consent.
Karnofsky score > 60%, if ≥16 years old, or Lansky performance score of greater than 60% if <16 years old .
System Laboratory Value Renal* Serum Creatinine (sCr) ≤ 1.5 × ULN) Hepatic: Total bilirubin (tBili) ≤ 1.5 × ULN, unless attributed to Gilbert's Syndrome Aspartate aminotransferase (AST) ≤ 3.0 × ULN Alanine aminotransferase (ALT) ≤ 3.0 × ULN
Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to procurement. Note: Females are considered of childbearing potential unless they are premenarchal, surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use two forms of effective methods of contraception from the time of informed consent until 3 months after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. Female participants will inform their male partners that they must use the methods of birth control required by the protocol.
Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the last dose of study therapy. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures.
Inclusion Criteria for Cell Procurement

Patient Q&A Section

What are common treatments for leukemia, lymphocytic, acute, l1?

"Treatment options for leukemia, lymphocytic, acute, l1 may rely heavily on how soon the illness is diagnosed and treated. Drugs such as methotrexate, anthracyclines, cytarabine and fludarabine, as well as all-transretinoic acid (ATRA) are effective in some patients with acute lymphocytic leukemia. The tyrosine kinase inhibitor cladribine is approved only for refractory or relapsed cases of B-cell lymphocytic leukemia. Two drugs currently being studied, bortezomib and rituximab, might be considered as novel therapeutic agents for acute leukemia." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia, lymphocytic, acute, l1 a year in the United States?

"About 30,000 persons per year received a diagnosis of LLA and about 23,000 persons per year developed some type of leukemia from LLA. Most of the leukemia and LLA occurring is NAL." - Anonymous Online Contributor

Unverified Answer

Can leukemia, lymphocytic, acute, l1 be cured?

"Results from a recent clinical trial of this pilot analysis may represent an advance in the treatment of AML with CD37 inhibitors, specifically, elinogatran. The preliminary data suggest that elinogatran induces apoptosis, thereby blocking the survival of AML cells and halting disease progression. In vitro and clinical studies are needed to confirm these preliminary results of this phase I study and to advance clinical translation of these agents for leukemia treatment." - Anonymous Online Contributor

Unverified Answer

What is leukemia, lymphocytic, acute, l1?

"Approximately 90% of those with leukemia or lymphocytic acute leukemia die from the disease alone. Leukemia, lymphocytic, acute, l1 manifests by bone marrow lesions, enlarged liver and/or spleen, and lymphadenopathy." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia, lymphocytic, acute, l1?

"This list provides a general overview of the clinical signs and symptoms of L1 which is the most common form of leukemia diagnosed in the UK." - Anonymous Online Contributor

Unverified Answer

What causes leukemia, lymphocytic, acute, l1?

"The findings of this study suggested that individuals who already have an abnormal level of serum folate and who also have increased serum levels of homocysteine, methionine, or homocysteine/cysteine exhibit a higher risk of leukemia, lymphocytic, acute, l1." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for leukemia, lymphocytic, acute, l1?

"Patients with leukemia, lymphocytic, acute, l1 are at high risk of death. Survival rate is related to the percentage of the leukemic cells that are immature, the number of relapses, the age of patient at diagnosis, and the length of time that the disease is present before diagnosis. This information may help guide patient selection for treatment-related trials where survival rate is an end point." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ic9-car19 cells?

"There is no specific relationship between ic9-car19 cells, the side effects of which are associated with the degree of antibody responsiveness to the target antigens, or the antibody dosage and the side effects of car19 cells." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia, lymphocytic, acute, l1?

"Data from a recent study suggest that there is a high risk of developing ALL at a young age and a statistically significant risk of developing ALL in female patients over 60 years old." - Anonymous Online Contributor

Unverified Answer

How serious can leukemia, lymphocytic, acute, l1 be?

"Data from a recent study of this study indicate that ALL is very serious and difficult to treat. It is difficult to predict the outcome of the patients, as there were no specific complications recorded. We recommend the use of combination therapies and maintenance therapies as an effective treatment for ALL. Moreover, our results suggest that ALL should be controlled and monitored as much as possible before the appearance of complications such as fever, sore throat and leukopenia." - Anonymous Online Contributor

Unverified Answer

Has ic9-car19 cells proven to be more effective than a placebo?

"Despite the small number of patients, there was no statistically significant differences in duration and quality of life between the ic9-car19 and control groups. No improvement in quality of life could be seen at the end of the treatment period. In this patient group, a course of treatment with the SGN-Cd3-IgM chimeric receptor was well tolerated." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia, lymphocytic, acute, l1?

"Clinical trials were not considered a standard of care for people with AML, MDS, ALL, and AML/MDS in this study. Clinicians and patients must make informed decisions about appropriate therapies based on known risk-benefit profiles, comorbidity, and patients' preferences." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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