CAR-T Cell Therapy for Hodgkin Lymphoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byHelen Heslop, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Tessa Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Helen Heslop, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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

My kidney function is good.

Signed Informed Consent Form

Hgb ≥ 8.0 g/dL

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Exclusion Criteria

I am currently taking drugs that suppress my immune system or long-term steroids.

I do not have active seizures, stroke, brain blood flow issues, severe memory loss, balance disorders, or autoimmune diseases affecting my brain.

Having received: Anti-CD30 antibody-based therapy within 4 weeks prior to CD30.CAR-T infusion, Prior investigational CD30.CAR-T, CD30 bispecific agent within 8 weeks prior to CD30.CAR-T infusion, Autologous HSCT within 90 days or allogeneic HSCT within 180 days prior to CD30.CAR-T infusion, Currently receiving any investigational agents within 4 weeks prior to study enrollment; or received any tumor vaccines within 6 weeks prior to CD30.CAR-T infusion, Active acute or chronic graft versus host disease (GVHD) requiring immune suppression regardless of grade, Evidence of human immunodeficiency virus (HIV) infection, Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments, History of hypersensitivity reactions to murine protein-containing products or other product excipients, Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification, Active second malignancy or history of another malignancy within the last 3 years, Women who are pregnant or intending to become pregnant; women who are breastfeeding; persons with procreative potential not using and not willing to use 2 highly effective methods of contraception, Any other serious, life-threatening, or unstable preexisting medical conditions

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Treatment Details

Interventions

CD30.CAR-T (CAR T-cell Therapy)

Trial OverviewThe CHARIOT study tests the safety and effectiveness of a personalized immune cell therapy called autologous CD30.CAR-T cells in patients with specific types of Hodgkin Lymphoma that haven't responded to previous treatments. It's an open-label trial where all participants receive the same experimental treatment without a comparison group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: CD30 positive r/r classical Hodgkin LymphomaExperimental Treatment3 Interventions

Patients with relapsed or refractory classical Hodgkin Lymphoma who have failed 3 prior lines of treatment, which may include a prior autologous and/or allogeneic stem cell transplant. Patients will be treated with autologous CD30.CAR-T cells.