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CAR T-cell Therapy

CAR T-Cell Therapy for Blood Cancer (CARPASCIO Trial)

Phase 1
Waitlist Available
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: Group A - CD19+ B-ALL undergoing allogeneic HSCT or Group B - CD19+ B cell CLL or NHL undergoing allogeneic HSCT
TREATMENT: Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A) OR any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B)
Must not have
Evidence of GVHD > grade II
Severe intercurrent infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with Non-Hodgkin Lymphoma (NHL), acute lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) who have relapsed or are refractory to treatment. Patients must have undergone a stem cell transplant from a donor and be in remission or have minimal residual disease.

Who is the study for?
This trial is for patients with certain blood cancers (NHL, ALL, CLL) that have returned or persisted despite treatment. Participants must be undergoing or have undergone a stem cell transplant and have an identified donor. They should not be on other investigational antitumor therapies, must meet specific health criteria like organ function, and agree to effective birth control use.
What is being tested?
The study tests the safety and effectiveness of CD19.CAR-CD28Z T Cells at escalating doses in fighting lymphoma/leukemia post-stem cell transplantation from a donor. It aims to determine the maximum safe dose, how long these modified T cells last in the body, side effects they may cause, and their potential benefits.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever or fatigue; risk of infection; possible allergic responses due to murine (mouse) protein components; and complications from infused T cells affecting normal tissues/organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in Group A with B-ALL or Group B with CLL/NHL and am getting a stem cell transplant.
Select...
I have CD19+ B-ALL, B-CLL, or NHL and am undergoing or will undergo a stem cell transplant.
Select...
My leukemia has returned or remains after my transplant, as shown by specific tests.
Select...
I am able to perform most of my daily activities.
Select...
My treatment involves T cells with a specific marker.
Select...
I have a suitable donor for a stem cell transplant.
Select...
My kidney function is good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My graft-versus-host disease is more severe than grade II.
Select...
I am currently suffering from a severe infection.
Select...
I am currently on a high dose of steroids for graft-versus-host disease.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with dose limiting toxicity
Secondary study objectives
Frequency of T cell products
Number of patients with tumor response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Subgroup B2Experimental Treatment1 Intervention
Patients with other B cell malignancies and with an unrelated or HLA-mismatched donor will receive CD19.CAR-CD28Z T Cells - dose escalation 2
Group II: Subgroup B1Experimental Treatment1 Intervention
Patients with other B-cell malignancies and with an HLA-matched related donor will receive CD19.CAR-CD28Z T Cells - dose escalation 1
Group III: Subgroup A2Experimental Treatment1 Intervention
Patients with residual or relapsed B-cell ALL and with an unrelated or HLA-mismatched donor will receive CD19.CAR-CD28Z T Cells - dose escalation 2
Group IV: Subgroup A1Experimental Treatment1 Intervention
Patients with residual or relapsed B-cell ALL and with an HLA-matched related donor will receive CD19.CAR-CD28Z T Cells - dose escalation 1

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,025 Previous Clinical Trials
6,029,772 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
286 Previous Clinical Trials
81,741 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,848 Total Patients Enrolled
Carlos A Ramos, MDPrincipal InvestigatorBaylor College of Medicine
5 Previous Clinical Trials
229 Total Patients Enrolled

Media Library

CD19.CAR-CD28Z T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02050347 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Subgroup B2, Subgroup A1, Subgroup A2, Subgroup B1
Acute Lymphoblastic Leukemia Clinical Trial 2023: CD19.CAR-CD28Z T Cells Highlights & Side Effects. Trial Name: NCT02050347 — Phase 1
CD19.CAR-CD28Z T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02050347 — Phase 1
~1 spots leftby Dec 2025
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