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CAR T-cell Therapy

CD22 CAR T-Cell Therapy for B-Cell Cancers

Phase 1

Waitlist Available

Led By Lori Muffly, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2; or Karnofsky ≥ 60%

Age greater than or equal to 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days after infusion of cd22 car t cells

Awards & highlights

Study Summary

This trial is testing whether a new immunotherapy treatment, using a patient's own immune cells, can be successful in treating adults with leukemia or lymphoma that has returned or does not respond to treatment.

Who is the study for?

Adults over 18 with certain B-cell blood cancers that have come back or didn't respond to treatment. They must be able to consent, not pregnant, willing to use birth control, and meet specific health criteria like a minimum number of white blood cells and proper organ function. Can't join if they're pregnant/breastfeeding, have other cancers within 3 years, severe infections needing IV drugs, significant heart issues in the past year or conditions affecting study participation.Check my eligibility

What is being tested?

The trial is testing CD22-CAR T cells made from patients' own immune cells against relapsed/refractory B-cell malignancies. It includes pre-treatment with Fludarabine and Cyclophosphamide which are chemotherapy drugs used to prepare the body for CAR T cell therapy.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever and fatigue (cytokine release syndrome), neurological events like confusion or seizures (neurotoxicity), low blood cell counts leading to increased infection risk, bleeding or anemia, and potential damage to organs where cancerous cells may accumulate.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but may not be able to do heavy physical work.

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I am 18 years old or older.

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My blood, kidney, liver, lung, and heart functions are normal.

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I have specific types of lymphoma and haven't had chemotherapy before it changed.

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My ALL hasn't responded to two treatments or has come back after a complete response.

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My cancer returned to the brain or spinal cord after it was previously gone.

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I have had a bone marrow or stem cell transplant.

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My condition is an aggressive type of B-cell Non-Hodgkin's Lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days after infusion of cd22 car t cells

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days after infusion of cd22 car t cells

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days after infusion of cd22 car t cells for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

T-Lymphocyte

Rate of successful manufacture of CD22 CAR T cells

Safe dose of CD22-CAR T cells in subjects with ALL

Secondary outcome measures

Clinical activity of CD22-CAR T cells in adults with relapsed/refractory CD22-expressing B-cell ALL at target dose

Clinical activity of CD22-CAR T cells in adults with relapsed/refractory aggressive B-cell NHL at MTD/RP2D

Trial Design

2Treatment groups

Experimental Treatment

Group I: R/R aggressive B-cell NHLExperimental Treatment3 Interventions

Relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Lymphodepletion prior to CD22 CAR T cell infusion (Day 0) will occur as follows: Fludarabine 30 mg/m2 per day IV for days 5, 4, 3 Cyclophosphamide 500 mg/m2 per day IV for days 5, 4, 3 Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) to determine MTD/RP2D. Dose1: 1 x 10^6 cells/kg (± 20%) Dose2: 3 x 10^6 cells/kg (± 20%) Dose3: 1 x 10^7 cells/kg (± 20%)

Group II: R/R ALLExperimental Treatment3 Interventions

Relapsed/refractory ALL Lymphodepletion prior to CD22 CAR T cell infusion (Day 0) will occur as follows: Fludarabine 30 mg/m2 per day IV for days 5, 4, 3 Cyclophosphamide 500 mg/m2 per day IV for days 5, 4, 3 Autologous CD22 CAR T cells will be administered intravenously at Dose1: 3 x 10^5cells/kg (± 20%) 10

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,333,998 Total Patients Enrolled

Lori Muffly, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

126 Total Patients Enrolled

Matthew Frank, MD, PhDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

120 Total Patients Enrolled

Media Library

CD22 CAR (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04088890 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: R/R ALL, R/R aggressive B-cell NHL

Acute Lymphoblastic Leukemia Clinical Trial 2023: CD22 CAR Highlights & Side Effects. Trial Name: NCT04088890 — Phase 1

CD22 CAR (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04088890 — Phase 1

Frequently Asked Questions

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

What is the primary purpose of administering CD22 CAR treatments?

"CAR-CD22 has been proven to work as an efficacious treatment for multiple sclerosis. Additionally, it is beneficial in managing cases of mixed-cell type lymphoma, leukemia, myelocytic and acute types of retinoblastoma."

Answered by AI

What prior experiments have been conducted involving CD22 CAR technology?

"889 clinical trials relating to CD22 CAR are currently operational with 161 of these studies being conducted in phase 3. The majority of the research is concentrated around Philadelphia, Pennsylvania but there are 28443 sites worldwide conducting similar experiments."

Answered by AI

Are there vacancies available to prospective participants of this clinical trial?

"According to clinicaltrials.gov, the research is in its recruitment stage. This trial was initially posted on September 12th 2019 and has been updated most recently on January 14th 2022."

Answered by AI

How many individuals are currently participating in this research initiative?

"Affirmative. According to the clinicaltrials.gov database, this particular research is actively seeking participants; first posted on September 12th 2019 and last updated January 14th 2022. The study requires enrolment of 92 patients from a single medical centre."

Answered by AI

Has the application for CD22 chimeric antigen receptor therapy been sanctioned by the Food and Drug Administration?

"Due to the experimental nature of this medical research, CD22 CAR has been rated a 1 on our safety scale. This is because Phase 1 trials provide limited evidence for efficacy and safety."

Answered by AI

Recent research and studies

BloodJournal

Cd22-directed CAR T-cell Therapy Induces Complete Remissions in Cd19-directed Car–refractory Large B-cell Lymphoma

Baird, John H., Matthew J. Frank, Juliana Craig, Shabnum Patel, Jay Y. Spiegel, Bita Sahaf, Jean S. Oak, et al.. 2021. “Cd22-directed CAR T-cell Therapy Induces Complete Remissions in Cd19-directed Car–refractory Large B-cell Lymphoma”. Blood. American Society of Hematology. doi:10.1182/blood.2020009432.

clinicaltrials.govStudy

Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies

2019. "Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04088890.