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Autologous Stem Cell Transplant + CAR T-Cell Therapy for B-Cell Lymphoma

Phase 1
Waitlist Available
Led By Craig Sauter, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation.
- Adequate pulmonary function as assessed by DLCO of ≥ 45% adjusted for hemoglobin
Must not have
- Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible
- Karnofsky performance status ≤ 70 (see appendix VI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing whether it's safe to give patients their own immune cells after high-dose chemotherapy and autologous stem cell transplantation.

Who is the study for?
This trial is for adults over 18 with aggressive B-cell non-Hodgkin lymphoma who've relapsed or are not responding to treatment. They should have a life expectancy of more than 3 months, good kidney and liver function, no severe heart or lung issues, and no other cancers that could interfere with the study. Those previously treated with bone marrow or stem cell transplants, or those with uncontrolled infections including HIV and hepatitis B/C can't participate.
What is being tested?
The trial tests high-dose chemotherapy followed by returning patients' own stem cells (ASCT) and then infusing their T-cells modified to target CD19+ B-cells (CAR-T therapy). It aims to see if this combination is safe for treating refractory/relapsed aggressive B-cell non-Hodgkin lymphoma.
What are the potential side effects?
Potential side effects include reactions related to immune cell infusion such as fever, fatigue, blood pressure changes; complications from high-dose chemotherapy like nausea, hair loss; risks associated with stem cell transplant including infection risk due to low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has returned or is not responding to treatment, and I can't have a bone marrow transplant.
Select...
My lung function is good, as shown by a specific breathing test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had a bone marrow or stem cell transplant.
Select...
I need assistance with my daily activities.
Select...
I do not have any ongoing serious infections.
Select...
I have an aggressive B-cell cancer not listed in the main criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
maximum tolerated dose (MTD)
safety

Side effects data

From 2020 Phase 1 & 2 trial • 34 Patients • NCT02059239
6%
Febrile Neutropenia
3%
Fever
3%
Tumor Lysis Syndrome
3%
Paroxysmal Atrial Tachycardia
3%
Syncope
3%
Heart Failure
3%
Pulmonary Hypertension
3%
Diarrhea
3%
Hypocalcemia
3%
Hypoxia
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine
Bendamustine Plus Autologous Transplantation
Bendamustine Plus Allogeneic Transplantation

Trial Design

1Treatment groups
Experimental Treatment
Group I: HIGH DOSE CHEMOTHERAPY AND ASCTExperimental Treatment7 Interventions
This is a phase 1 dose escalation study designed to determine the maximum tolerated dose (MTD) of CAR modified T cells in patients with relapsed and refractory aggressive B-NHL. Three dose levels (5 x 106 19-28z T cells/kg, 1 x 107 19-28z T cells/kg, and 2 x 107 19-28z T cells/kg) are considered for the MTD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegfilgrastim
2013
Completed Phase 3
~4440
Carmustine
1990
Completed Phase 3
~1820
Etoposide
2010
Completed Phase 3
~2960
Cytarabine
2016
Completed Phase 3
~3330
Melphalan
2008
Completed Phase 3
~1500
Autologous Stem Cell Transplantation
2012
Completed Phase 3
~1000

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,539 Total Patients Enrolled
Craig Sauter, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
59 Total Patients Enrolled
Mark Geyer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Autologous Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT01840566 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: HIGH DOSE CHEMOTHERAPY AND ASCT
Non-Hodgkin's Lymphoma Clinical Trial 2023: Autologous Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT01840566 — Phase 1
Autologous Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT01840566 — Phase 1
~1 spots leftby Apr 2025
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