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CAR T-cell Therapy

CAR T-Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Led By Nirali N Shah, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment

Participant must have evidence of at least minimal residual disease or PET-avid disease at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly until 3 months post infusion and then at 6 months and every 6 months after that, for 2 years post-infusion for each participant, for up to two years from the entry date of the last participant

Awards & highlights

Study Summary

This trial is testing CAR therapy, which is a treatment for acute lymphoblastic leukemia (ALL) that uses genetically modified cells created from the patient's own blood cells.

Who is the study for?

This trial is for children and young adults aged 3 to 35 with B-cell malignancies like ALL or lymphoma that's come back or didn't respond to treatment. They must have tried at least one standard chemo and one additional therapy, may have had a stem cell transplant, and can't be pregnant or breastfeeding. Participants need decent heart and lung function, no severe infections (HIV/HBV/HCV), no other cancers unless cured over two years ago, and must agree to birth control measures.Check my eligibility

What is being tested?

The study tests a new CAR T-cell therapy targeting both CD19/CD22 proteins on cancer cells. It involves modifying the patient's own T cells in the lab after chemotherapy preparation. Patients will receive their modified T cells back into their body in hospital settings followed by regular clinic visits for monitoring over an extended period of up to 15 years.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever, fatigue, headache, drops in blood pressure; organ inflammation; complications from low blood cell counts; possible neurological events like confusion or seizures; allergic reactions during infusion of the modified T cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer did not respond to initial chemotherapy and a follow-up treatment.

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My tests show some remaining cancer cells or active cancer.

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I cannot have, refused, or had cancer return after a stem cell transplant.

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My cancer is a type of blood cancer like ALL, CML in ALL phase, or high-grade lymphoma.

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I have ALL and my previous treatment with a specific drug type didn't work.

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My cancer cells test positive for CD22.

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I am between 3 and 35 years old.

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I am 16 or older with a Karnofsky score of 50% or higher, or under 16 with a Lansky score of 50% or higher.

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My cancer cells are mostly CD19 positive.

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I can't get, didn't qualify for, or didn't improve with a specific cancer treatment (CD19 CAR T-cell).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly until 3 months post car t infusion and then at 6 months and every 6 months after that, for 2 years post-infusion for each participant, up to 2 years after the entry date of the last participant.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly until 3 months post car t infusion and then at 6 months and every 6 months after that, for 2 years post-infusion for each participant, up to 2 years after the entry date of the last participant.

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly until 3 months post car t infusion and then at 6 months and every 6 months after that, for 2 years post-infusion for each participant, up to 2 years after the entry date of the last participant. 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

Safety

Secondary outcome measures

Adverse Events

Assess response and toxicity (CRS grade)

Feasibility

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: 4/Phase II Dose Expansion- with high disease burdenExperimental Treatment3 Interventions

CD19/CD22-CAR-transduced T cells at MTD/or highest dose administered with LD regimen #2

Group II: 3/Phase II Dose Expansion- with low disease burdenExperimental Treatment3 Interventions

CD19/CD22-CAR-transduced T cells at MTD/or highest dose administered with LD

Group III: 2b/Phase 1 Dose Escalation - high disease burdenExperimental Treatment3 Interventions

CD19/CD22-CAR-transduced T cells

Group IV: 2/Phase I Dose Escalation- with intensified LD - CLOSEDExperimental Treatment3 Interventions

CD19/CD22-CAR-transduced T cells + standard LD

Group V: 1b/Phase 1 Dose Escalation - low disease burdenExperimental Treatment3 Interventions

CD19/CD22-CAR-transduced T cells

Group VI: 1/Phase I Dose Escalation-with standard LD - CLOSEDExperimental Treatment3 Interventions

CD19/CD22-CAR-transduced T cells at escalating dose + standard LD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fludarabine

2012

Completed Phase 3

~6760

cyclophosphamide

1994

Completed Phase 3

~8140

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,664 Previous Clinical Trials

40,925,890 Total Patients Enrolled

Nirali N Shah, M.D.Principal InvestigatorNational Cancer Institute (NCI)

13 Previous Clinical Trials

2,413 Total Patients Enrolled

Media Library

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05442515 — Phase 1 & 2

B-Cell Leukemia Research Study Groups: 2b/Phase 1 Dose Escalation - high disease burden, 1/Phase I Dose Escalation-with standard LD - CLOSED, 2/Phase I Dose Escalation- with intensified LD - CLOSED, 1b/Phase 1 Dose Escalation - low disease burden, 4/Phase II Dose Expansion- with high disease burden, 3/Phase II Dose Expansion- with low disease burden

B-Cell Leukemia Clinical Trial 2023: CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells Highlights & Side Effects. Trial Name: NCT05442515 — Phase 1 & 2

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05442515 — Phase 1 & 2

Frequently Asked Questions

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

If a patient is octogenarian, can they still participate in this research?

"The target age group for recruitment in this trial are people who fall between 3 to 35 years old."

Answered by AI

Are we currently looking for participants in this trial?

"This study is no longer testing for new patients, however this information was last updated on 11/17/2022. As of now, there are 2999 other medical trials that are still looking for participants."

Answered by AI

How can I become involved in this research project?

"The age limit for this study is 3-35 years old and the total number of participants that will be enrolled is 146. To be accepted, patients must have a diffuse form of lymphoma."

Answered by AI

What are the aims of this research?

"The purpose of this study, as CAR T cells will be monitored for approximately 30 days post-infusion, is to assess efficacy. Additionally, researchers will secondary measure overall response rate (ORR), persistence and expansion of CD19/CD22-CAR T cells, and progression free survival (PFS) and overall survival (OS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

2022. "CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442515.