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CAR T-cell Therapy
CAR-NK Cell Therapy for Blood Cancers
Phase 1 & 2
Recruiting
Led By chitra hosing
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
B. Chronic lymphocytic leukemia (CLL) Chronic lymphocytic leukemia (CLL) small lymphocytic lymphoma (SLL), Richter's transformation of CLL or SLL who have received at least 2 lines of standard chemoimmunotherapy or targeted therapy and have persistent disease C. Mantle cell lymphoma Relapsed or refractory mantle cell lymphoma after 2 lines of standard chemoimmunotherapy including a BTKi
- Cardiac: Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment using CAR-NK cells to see if it is safe and effective, as well as finding the best dose for different diseases.
Who is the study for?
This trial is for adults aged 18-80 with relapsed/refractory blood cancers like T-cell malignancies, mantle cell lymphoma, and chronic lymphocytic leukemia. They must have tried at least two treatments before, be in good physical condition (Karnofsky score >50%), not pregnant or breastfeeding, and willing to use birth control. Patients should not have severe ongoing side effects from past treatments or active infections.Check my eligibility
What is being tested?
The study tests CAR 5/IL15-transduced CB-NK cells combined with Fludarabine Phosphate and Cyclophosphamide chemotherapy to find the safest and most effective dose for treating certain blood cancers that haven't responded well to other therapies.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever or fatigue, complications from chemotherapy like nausea or low blood counts, and risks associated with new gene therapy techniques which will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart functions well, with no serious fluid around it or uncontrolled heart rhythm problems.
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My kidney function is normal, with creatinine ≤ 1.5 or eGFR ≥ 60.
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My blood cancer cells show high levels of CD5.
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I will use effective birth control during and up to 3 months after the study.
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My T-lymphoid cancer came back after standard treatment or a stem cell transplant.
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I can do most of my daily activities by myself.
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My condition is either T-cell non-Hodgkin's lymphoma or T-cell acute lymphoblastic leukemia.
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I am between 18 and 80 years old.
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I have a type of T-cell cancer and it's still detectable after at least 2 treatments.
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I weigh at least 40 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2 Dose LevelExperimental Treatment3 Interventions
Patients will be randomized between the 2 optimal doses of CAR.5/IL15-transduced CB-NK cells determined by Phase 1.
All patients will receive Lymphodepleting Chemotherapy of Cyclophosphamide and Fludarabine.
Group II: Phase 1 Dose LevelExperimental Treatment3 Interventions
CAR.5/IL15-transduced CB-NK cells Dose level 1, 1e7 cryopreserved cells flat dose Dose level 2, 1e8 cryopreserved cells flat dose Dose level 3, 1e9 cryopreserved cells flat dose Dose level 4, 1e10 cryopreserved cells flat dose
All patients will receive Lymphodepleting Chemotherapy of Cyclophosphamide and Fludarabine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,298 Total Patients Enrolled
chitra hosingPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart functions well, with no serious fluid around it or uncontrolled heart rhythm problems.I am not on high-dose steroids or recent strong immune treatments.I have active hepatitis B or C.My kidney function is normal, with creatinine ≤ 1.5 or eGFR ≥ 60.My blood cancer cells show high levels of CD5.You have another serious medical condition that could put your health at risk, as determined by the doctor in charge of the study.I have not had a stem cell transplant or donor lymphocyte infusion in the last 12 weeks.I haven't had chemotherapy for at least 3 weeks and can stop targeted therapies 3 days before starting new treatment.My organs are working well.My T-lymphoid cancer came back after standard treatment or a stem cell transplant.I am currently on immunosuppressive therapy.My cancer has spread to my brain or its coverings.I have no active cancer except for treated cervical pre-cancer or non-melanoma skin cancer.I can do most of my daily activities by myself.My liver function tests are within the required range and I don't have liver cirrhosis or ascites.I have an infection that isn't getting better with treatment.I am between 18 and 80 years old.My condition is either T-cell non-Hodgkin's lymphoma or T-cell acute lymphoblastic leukemia.I have not had an active autoimmune disease in the last year.My lungs function well, with oxygen levels above 92% without assistance.I will use effective birth control during and up to 3 months after the study.I am currently receiving treatment for active graft-versus-host disease.I have a type of T-cell cancer and it's still detectable after at least 2 treatments.I've had radiotherapy on some cancer sites, but others haven't been treated.I am a woman capable of becoming pregnant and have not been menopausal for 24 months, nor have I been surgically sterilized.I have an active neurological disorder.I have HIV with a detectable viral load.You are not allowed to use other experimental drugs at the same time.I have not had major surgery within the last 4 weeks.I weigh at least 40 kg.I have severe side effects from past treatments.I am not using other cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Level
- Group 2: Phase 2 Dose Level
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are allowed to enroll in this research project?
"Unfortunately, this study is no longer admitting new participants. It was originally posted on June 30th 20222 and last updated on May 5th, 2022. However, there are currently 278 other trials for hematologic neoplasms and 948 CAR-5/IL15 transduced CB-NK cell clinical trials that patients can sign up for."
Answered by AI
Are people with the qualifying condition able to enroll in this trial right now?
"According to information found on clinicaltrials.gov, this particular study is no longer looking for patients to enroll. Although the trial was last updated on May 5th, 2022, it is not currently recruiting any candidates. There are 1226 other trials that might be of interest and are actively searching for volunteers."
Answered by AI
What are CAR.5/IL15-transduced CB-NK cells most often utilized for?
"CAR.5/IL15-transduced CB-NK cells are commonly used to treat multiple sclerosis, as well as leukemia, myelocytic, acute, retinoblastoma, and histiocytic lymphoma."
Answered by AI
What are the most recent findings on CAR.5/IL15-transduced CB-NK cells in relation to clinical trials?
"In total, there are 948 ongoing clinical trials studying the efficacy of CAR.5/IL15-transduced CB-NK cells. Of these studies, 165 are in Phase 3 and the majority of them are based in Philadelphia, Pennsylvania; though, there are 28673 locations running Phase 3 trials for this treatment globally."
Answered by AI
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