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CAR T-cell Therapy

CAR T-Cells + CMV Vaccine for Non-Hodgkin's Lymphoma

Phase 1
Recruiting
Led By Alex Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
Absolute neutrophil count >= 1000/uL (Transfusions and growth factors must not be used to meet this requirement at initial screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing the safety of CMV-specific CD19-CAR T-cells in combination with the CMV-MVA triplex vaccine following a stem cell transplant in people with high grade B-cell non-Hodgkin lymphoma.

Who is the study for?
Adults over 18 with certain types of B-cell non-Hodgkin lymphoma, who are in first relapse or didn't respond to initial treatment. They must be CMV positive, have a good performance status (able to carry out daily activities), and proper organ function. Pregnant women, those with prior stem cell transplants, autoimmune diseases needing steroids, other active cancers or infections can't join.Check my eligibility
What is being tested?
The trial is testing genetically modified T-cells targeting CD19 on cancer cells plus a CMV vaccine after stem cell transplantation. The aim is to see if this combination helps prevent the return of high-grade B-cell non-Hodgkin lymphoma after transplant.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, flu-like symptoms from the vaccine, increased risk of infection due to immune system modification and potential complications from stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and my pregnancy test is negative.
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My white blood cell count is healthy without medical help.
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My hemoglobin level is at least 8 g/dl without transfusions or growth factors.
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My kidney function is within the required range and I am not on dialysis.
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I have B cell NHL and am in my first relapse or didn't achieve complete remission after first treatment.
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My platelet count is high enough without transfusions or growth factors.
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My white blood cell count is high enough without medical help.
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I am capable of having children and have not been surgically sterilized.
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My hemoglobin level is at least 8 g/dl without transfusions or growth factors.
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My kidney function is within the required range and I am not on dialysis.
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I am 18 years old or older.
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I have B cell NHL in first relapse and may need a stem cell transplant.
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I am able to care for myself but may not be able to do active work.
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My cancer is confirmed to be a type of CD19+ malignancy.
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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My cancer is confirmed to be a type of CD19+ with intermediate or high severity.
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I have no allergies or adverse reactions to specific cancer treatments, steroids, or certain vaccines.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Achievement of proposed 10×10^6 cytomegalovirus (CMV)-specific CD19-chimeric antigen receptor (CAR) T cells per product and meeting product release requirements for enrolled participants
Clinically significant CMV reactivation
Overall survival (OS)
+2 more

Side effects data

From 2022 Phase 3 trial • 665 Patients • NCT00567567
84%
58300-Neutrophil count decreased
70%
65800-Platelet count decreased
20%
43100-Hypokalemia
18%
44800-Infections and infestations - Other specify
18%
33300-Febrile neutropenia
17%
88500-White blood cell decreased
13%
13200-Anemia
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
57600-Nausea
3%
65900-Pleural effusion
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
23000-Confusion
1%
34000-Fibrinogen decreased
1%
73900-Serum amylase increased
1%
26600-Duodenal obstruction
1%
71500-Respiratory failure
1%
42600-Hypoalbuminemia
1%
45800-INR increased
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
66300-Pneumonitis
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
69700-Rash maculo-papular
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CMV-specific CD19-CAR T cells, triplex vaccine)Experimental Treatment4 Interventions
CONDITIONING REGIMEN: Patients receive standard conditioning regimen (typically carmustine, etoposide, cytarabine, melphalan) beginning approximately on day -9 in the absence of disease progression or unacceptable toxicity. TRANSPLANTATION: Patients undergo autoHSCT on day -2. CAR T-CELLS AND VACCINATION: Patients receive CMV-specific CD19-CAR T cells IV on day 0 and CMV-MVA triplex vaccine IM on days 28 and 56 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,237 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,332 Total Patients Enrolled
Alex HerreraPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
101 Total Patients Enrolled

Media Library

Anti-CD19-CAR CMV-specific T-lymphocytes (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05432635 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (CMV-specific CD19-CAR T cells, triplex vaccine)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Anti-CD19-CAR CMV-specific T-lymphocytes Highlights & Side Effects. Trial Name: NCT05432635 — Phase 1
Anti-CD19-CAR CMV-specific T-lymphocytes (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05432635 — Phase 1

Frequently Asked Questions

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

Are there any vacant spots left in this trial?

"Per the clinicaltrials.gov listing, this research study is actively recruiting patients; it was first announced on November 2nd 2022 and has recently been updated as of October 7th 2022."

Answered by AI

Has Autologous Hematopoietic Stem Cell Transplantation been officially sanctioned by the U.S. Food and Drug Administration?

"Due to the limited evidence of safety and efficacy, Autologous Hematopoietic Stem Cell Transplantation was assigned a score of 1 on our team's scale from one to three."

Answered by AI

How many individuals have joined the clinical trial thus far?

"Indeed, the data found on clinicaltrials.gov reveals that this medical study is still recruiting participants. This trial was initially posted in November 2nd 2022 and most recently amended on October 7th 2022; 15 patients are needed from a single site."

Answered by AI
~10 spots leftby Mar 2028