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Monoclonal Antibodies
TTI-621/TTI-622 + Pembrolizumab for Lymphoma
Phase 2
Recruiting
Led By Stephen M, Ansell, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing two fusion proteins, TTI-621 and TTI-622, in combination with pembrolizumab to treat patients with relapsed diffuse large B-Cell lymphoma. The fusion proteins work by binding to proteins on the surface of immune cells and blocking a protein called CD47, which is present on cancer cells. Pembrolizumab is an antibody that helps the body's immune system attack the cancer. The combination of these three drugs may kill more cancer cells in patients with relapsed or refractory diffuse large B-cell lymphoma.
Who is the study for?
Adults with relapsed or refractory diffuse large B-cell lymphoma can join this trial. They must have had prior treatment with an anti-CD20 monoclonal antibody and chemotherapy, be in good physical condition, and not have other current cancers or severe diseases. Women of childbearing age need to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and optimal doses of TTI-621 or TTI-622 combined with pembrolizumab. These fusion proteins may help the immune system detect and destroy cancer cells by blocking a protein called CD47 that cancer cells use to avoid immune detection.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's increased activity against cancer cells, which could potentially affect normal organs as well. Specific side effects are not listed but generally align with those typical of immunotherapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response (Phase 2)
Recommended phase 2 dose of TTI-621 and TTI-622 when given in combination with pembrolizumab (Safety run-in)
Secondary outcome measures
Duration of response (DOR) (Phase 2)
Incidence of adverse events (AEs) (Phase 2)
Overall survival (OS) (Phase 2)
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (pembrolizumab, TTI-622)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle and TTI-622 IV over 60-90 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT scans or CT scans of the chest, abdomen, and pelvis prior to cycle 3 and every 4 cycles thereafter. If no disease progression after cycle 12, patients then receive pembrolizumab IV over 30 minutes on days 1 of each cycle and TTI-622 IV over 60-90 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (pembrolizumab, TTI-621)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle and TTI-621 IV over 60-120 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT scans or CT scans of the chest, abdomen, and pelvis prior to cycle 3 and every 4 cycles thereafter. If no disease progression after cycle 12, patients then receive pembrolizumab IV over 30 minutes on days 1 of each cycle and TTI-621 IV over 60-120 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,944 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,767,095 Total Patients Enrolled
Stephen M, Ansell, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I am 18 years old or older.I have or had cancer types other than the one I am seeking treatment for.I have a long-term infection.I had radiation therapy less than 2 weeks ago.It has been over 4 weeks since my last anti-CD20 therapy dose.I have previously received anti CD47 therapy.I am on medication for my seizure disorder.I do not have any uncontrolled illnesses.I am currently taking blood thinners like warfarin.My cancer is a type of B-cell neoplasm that is CD20 positive.I am fully active or can carry out light work.I've had less than 2 cancer treatments in the last 4 weeks or 5 half-lives.I am taking no more than 10 mg of glucocorticoids daily for the last 14 days.It has been over 12 weeks since my last CAR T-cell therapy.My side effects from previous treatments have mostly gone away.I have not had major surgery in the last 4 weeks.I have an autoimmune disease or a condition causing permanent immunosuppression.I have a known heart condition.I have a history of hepatitis B or currently have hepatitis C.I had my own stem cell transplant less than 100 days ago or have never had a transplant from a donor.My lymphoma affects my brain or spinal cord.I have not received a live vaccine in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (pembrolizumab, TTI-621)
- Group 2: Arm B (pembrolizumab, TTI-622)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the U.S. Food and Drug Administration authorized Pembrolizumab?
"Our team at Power judged the safety of Pembrolizumab to be a 2 due to there being only limited data available regarding its efficacy. However, we had access to multiple rounds of evidence that backed up its security."
Answered by AI
Is recruitment still open for participants in this trial?
"As indicated on clinicaltrials.gov, the study is no longer recruiting new participants as it was first published in November 1st 2022 and lastly updated on August 17th 2022. However, there are presently 3015 other trials actively seeking volunteers."
Answered by AI
What is the primary objective of this medical experiment?
"This clinical trial seeks to measure the overall response of patients over a 6-week period. Secondary outcomes are based on the patient's overall survival, duration of response and incidence rate for adverse events. The Kaplan-Meier method is used to estimate the distribution of OS with median estimates and two-sided 95% confidence intervals presented alongside. Additionally, frequency tables will be reviewed to determine any patterns in regards to AEs present within participants who have initiated treatment, factoring in its relation with study treatments too."
Answered by AI
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