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CAR T-cell Therapy
CAR-37 T Cells for Blood Cancers
Phase 1
Waitlist Available
Led By Matthew J. Frigault, MD
Research Sponsored by Marcela V. Maus, M.D.,Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of relapsed/refractory (R/R) CD37+ hematologic malignancy as defined as one of the following:
----- Subjects with standard-risk features must have failed at least 2 lines of prior therapy, including a BTKi OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying how well it works in treating people with relapsed or refractory CD37+ hematologic malignancies.
Who is the study for?
This trial is for adults over 18 with certain blood cancers like B-cell lymphoma, leukemia, and T-cell lymphoma that have come back or didn't respond to treatment. They must be in decent physical shape (ECOG 0-2), have tried specific previous treatments including anti-CD20 therapy and possibly a BTK inhibitor, and not be pregnant or breastfeeding. People can't join if they've had recent heart problems, other cancer treatments within the last week (except low-dose steroids), or active infections.Check my eligibility
What is being tested?
The study tests CAR-37 T Cells as an experimental therapy for patients with CD37+ hematologic malignancies that are relapsed/refractory. It aims to evaluate the effectiveness of this treatment and understand its side effects.See study design
What are the potential side effects?
Potential side effects of CAR-37 T Cell therapy may include immune system reactions, infusion-related symptoms such as fever or chills, fatigue, organ inflammation due to immune response, infection risk increase due to weakened immunity from the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned or didn't respond to treatment and tests positive for CD37.
Select...
I have standard-risk cancer and failed at least 2 treatments, including a BTK inhibitor.
Select...
My condition is Follicular Lymphoma grade 1, 2, or 3a.
Select...
I have tried at least one or two treatments for my condition without success.
Select...
I have received chemotherapy that included anthracycline or bendamustine.
Select...
I have high-risk features in my condition and have tried at least one treatment that didn't work.
Select...
I can care for myself and am up more than 50% of my waking hours.
Select...
My condition relapsed after 2 treatments, one being an anti-CD20 antibody.
Select...
My condition didn't improve after 2 treatments, including one with an anti-CD20 antibody.
Select...
I have a mature B cell cancer.
Select...
I have received anti-CD20 monoclonal antibody therapy.
Select...
I have high-risk features and failed at least one treatment, including a BTK inhibitor.
Select...
My diagnosis is a type of aggressive lymphoma.
Select...
My kidneys work well enough, with a creatinine clearance over 30 ml/min.
Select...
I have CLL and need treatment as per guidelines, with signs like high lymphocyte count or enlarged liver/spleen.
Select...
My liver tests are within the normal range.
Select...
My tumor shows CD37 presence.
Select...
My condition is a type of mature T cell cancer.
Select...
I cannot take BTK inhibitors and have tried at least one high-risk or two standard-risk treatments without success.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity
The occurrence of study related adverse events
Secondary outcome measures
Disease Specific Response
Overall Survival
Progression Free Survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: CAR-37 T cells Dose EscalationExperimental Treatment1 Intervention
CAR-37 will be administered intravenously on day 0
Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume.
CAR-37 will undergo dose escalation
Group II: CAR-37 T cellsExperimental Treatment1 Intervention
CAR-37 will be administered intravenously on day 0
Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume.
Subjects will receive 3 days of lymphodepleting chemotherapy starting Day -5, before the infusion of CAR-37 T cells on Day 0
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAR-37 T cells
2020
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Marcela V. Maus, M.D.,Ph.D.Lead Sponsor
4 Previous Clinical Trials
78 Total Patients Enrolled
Matthew J. Frigault, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received treatments targeting CD37 before.I am currently on long-term immune system suppressing drugs.I am currently on or have been treated with BTK inhibitor therapy.I do not have any ongoing serious infections.I am 18 years old or older.My cancer has returned or didn't respond to treatment and tests positive for CD37.I have standard-risk cancer and failed at least 2 treatments, including a BTK inhibitor.My condition is Follicular Lymphoma grade 1, 2, or 3a.I have tried at least one or two treatments for my condition without success.I can't tolerate BTK inhibitors and have tried other treatments without success.I have received chemotherapy that included anthracycline or bendamustine.I am on immunosuppressants due to GVH from a bone marrow transplant over 12 weeks ago.My blood tests show enough neutrophils and platelets without needing growth factors or transfusions.I have high-risk features in my condition and have tried at least one treatment that didn't work.I have a history of severe heart failure or non-ischemic cardiomyopathy.I can care for myself and am up more than 50% of my waking hours.My condition is Marginal Zone Lymphoma, either nodal or extranodal.I have chronic lymphocytic leukemia.My cancer returned after 2 treatments or after a stem cell transplant, or I have TPLL.I can follow the study's schedule and all its requirements.I had a blood clot in my lung less than 6 months ago.My condition relapsed after 2 treatments, one being an anti-CD20 antibody.My previous treatments include specific therapies.My condition didn't improve after 2 treatments, including one with an anti-CD20 antibody.I have a mature B cell cancer.I have received anti-CD20 monoclonal antibody therapy.I have high-risk features and failed at least one treatment, including a BTK inhibitor.I have received previous treatment.I have received previous treatments as required.I have another cancer besides my current one, but it's either in remission, was a skin cancer treated successfully, or is a prostate cancer treated only with hormones.My condition relapsed after 2 treatments or a stem cell transplant, or I can't have a stem cell transplant.I have been diagnosed with small lymphocytic lymphoma.I have a history of stroke or blood vessel disease and need blood thinners.I have SLL with specific symptoms and blood cell counts.My diagnosis is a type of aggressive lymphoma.I have been diagnosed with PTCL or CTCL.My kidneys work well enough, with a creatinine clearance over 30 ml/min.You have received any experimental cellular therapy within the past 8 weeks.I have CLL and need treatment as per guidelines, with signs like high lymphocyte count or enlarged liver/spleen.My liver tests are within the normal range.My tumor shows CD37 presence.I haven't had cancer treatment except for low-dose steroids in the last week.I can't tolerate BTK inhibitors and have tried other treatments without success.My condition is a type of mature T cell cancer.I cannot take BTK inhibitors and have tried at least one high-risk or two standard-risk treatments without success.I haven't had recent serious heart issues like unstable angina or heart attacks.
Research Study Groups:
This trial has the following groups:- Group 1: CAR-37 T cells Dose Escalation
- Group 2: CAR-37 T cells
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.
Did the FDA give their okay to CAR-37 T cells?
"CAR-37 T cells are in Phase 1 of clinical trials, meaning that there is only preliminary evidence to support its safety and efficacy."
Answered by AI
How many test subjects are included in this research?
"The answer is affirmative, according to clinicaltrials.gov this study requires new participants and is currently recruiting patients. This research was first advertised on June 19th 2020 with the latest update being October 28th 2021. 18 individuals are needed to take part at 1 location."
Answered by AI
Are investigators currently enrolling participants for this research?
"Indeed, the listing on clinicaltrials.gov reveals that this trial is currently seeking volunteers. This research project was originally posted on June 19th 2020 with the most recent update occurring on October 28th 2021. Only 18 individuals are needed for this study taking place at a single site."
Answered by AI
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