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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia and Lymphoma (SAGAN Trial)

Phase 1
Recruiting
Led By Carlos A Ramos, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PROCUREMENT: CD19-positive tumor.
TREATMENT: CD19-positive tumor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

SAGAN Trial Summary

This trial is testing a new cancer treatment combining two existing methods: T cells and antibodies. Researchers hope that the combination will be stronger than either method alone in fighting the cancer.

Who is the study for?
This trial is for people up to 75 years old with certain types of blood cancers like B-cell lymphoma, ALL, or CLL that have come back or didn't respond to treatment. They should be fit enough for the study and not have infections needing antibiotics, HIV/HTLV, or a history of severe reactions to mouse proteins.Check my eligibility
What is being tested?
The trial tests two modified T-cell therapies against aggressive blood cancers. One therapy includes CD19.CAR/28 T cells; the other adds CD137 to enhance effectiveness. The goal is to find the safest high dose, understand side effects, and see if these therapies can help patients.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to engineered T-cells targeting cancer cells but could also affect normal cells inadvertently. Specifics will be monitored closely given this is an investigational approach.

SAGAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is CD19 positive.
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My tumor is CD19 positive.
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My kidneys are functioning well.
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My oxygen level is above 90% without needing extra oxygen.
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I am mostly independent and can care for myself.
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My treatment involves T cells from my blood or an identical twin that target CD19.

SAGAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with dose limiting toxicity (DLT)
Secondary outcome measures
Frequency of the two distinct T cell products post infusion
Function of CD19.CAR-ATLs
Number of patients with tumor response
+2 more

SAGAN Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion: CD19 CAR T Cells for B-cell NHL/CLLExperimental Treatment1 Intervention
Each patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.
Group II: Dose Expansion: CD19 CAR T Cells for B-cell ALLExperimental Treatment1 Intervention
Each patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.
Group III: Dose Escalation: CD19 CAR T Cells for B-cell NHL/CLLExperimental Treatment1 Intervention
Each patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.
Group IV: Dose Escalation: CD19 CAR T Cells for B-cell ALLExperimental Treatment1 Intervention
Each patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,833 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,753 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,184 Total Patients Enrolled

Media Library

CD19.CAR/28 and CD19.CAR/28137 T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01853631 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Dose Escalation: CD19 CAR T Cells for B-cell ALL, Dose Expansion: CD19 CAR T Cells for B-cell ALL, Dose Escalation: CD19 CAR T Cells for B-cell NHL/CLL, Dose Expansion: CD19 CAR T Cells for B-cell NHL/CLL
Non-Hodgkin's Lymphoma Clinical Trial 2023: CD19.CAR/28 and CD19.CAR/28137 T cells Highlights & Side Effects. Trial Name: NCT01853631 — Phase 1
CD19.CAR/28 and CD19.CAR/28137 T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01853631 — Phase 1

Frequently Asked Questions

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

Is this research endeavor currently looking for participants?

"Clinicaltrials.gov reveals that this medical study is currently enrolling patients, with the initial listing being posted on February 1st 2014 and updated most recently on January 11th 2022."

Answered by AI

In what medical circumstances is Cyclophosphamide typically utilized?

"Primarily used to combat multiple sclerosis, cyclophosphamide has also been prescribed in cases of mixed-cell type lymphoma, leukemia, myelocytic, acute and retinoblastoma."

Answered by AI

Has the Federal Drug Administration sanctioned Cyclophosphamide?

"The safety of cyclophosphamide, which is being evaluated in a Phase 1 setting, has been assessed as low relative to other drugs with only limited evidence vouching for its efficacy and security."

Answered by AI

Could you elucidate on previous investigations involving Cyclophosphamide?

"Presently, 889 clinical trials are underway in an effort to further understand Cyclophosphamide. Of these studies, 161 have progressed as far as Phase 3 and boast 28443 locations of operation with Philadelphia, Pennsylvania being the most prevalent."

Answered by AI

How many participants are included in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is currently in the process of recruiting patients since it was posted on February 1st 2014 and recently updated on January 11th 2022. The goal is to secure 64 participants from two sites for the study."

Answered by AI
~4 spots leftby Dec 2024