CAR-T Cell Therapy for Hodgkin Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on immunosuppressive drugs or chronic systemic corticosteroids, and you must not have received certain treatments like anti-CD30 antibody-based therapy or investigational agents within specific time frames before the trial.
Is CD30 CAR-T cell therapy safe for humans?
CD30 CAR-T cell therapy has shown a favorable safety profile in clinical trials, with low rates of side effects like cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly) and no observed neurotoxicity (damage to the nervous system). Most patients' physical function and symptom burden returned to baseline levels within a month after treatment.12345
How is the CD30.CAR-T treatment different from other treatments for Hodgkin Lymphoma?
CD30.CAR-T treatment is unique because it uses specially modified immune cells (T cells) to target and attack cancer cells that express the CD30 protein, which is common in Hodgkin Lymphoma. This approach is different from traditional chemotherapy or radiation, as it specifically harnesses the body's immune system to fight the cancer.16789
What data supports the effectiveness of the treatment CD30.CAR-T for Hodgkin Lymphoma?
Research shows that CD30.CAR-T cell therapy can be effective for Hodgkin Lymphoma, with some patients experiencing partial remission or stable disease. The treatment is generally well-tolerated, with low toxicity, and patients often return to their baseline health within a month after treatment.12568
Who Is on the Research Team?
Helen Heslop, MD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals aged 12-75 with relapsed or refractory classical Hodgkin Lymphoma, who have tried at least three prior therapies. They must have CD30-positive tumors, measurable lesions, adequate organ function and no severe heart or lung issues. Excluded are those with CNS lymphoma involvement, recent other cancer treatments, active infections like HIV/HBV/HCV, ongoing immunosuppression therapy, certain cardiovascular diseases or pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and Bridging Chemotherapy
Blood is drawn for CD30.CAR-T cell manufacturing; bridging chemotherapy may be administered
Lymphodepletion and CD30.CAR-T Infusion
Lymphodepletion with fludarabine and bendamustine followed by CD30.CAR-T infusion
Treatment Monitoring
Participants are closely monitored for safety and efficacy until the end of study visit at Month 24
Long-term Follow-up
Participants enter long-term follow-up for survival, safety, efficacy, and biomarker assessments
What Are the Treatments Tested in This Trial?
Interventions
- CD30.CAR-T
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tessa Therapeutics
Lead Sponsor