Active — Not RecruitingPhase 1

Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

United States21 participantsStarted 2021-09-08

Plain-language summary

This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed Informed Consent Form
✓. Male or female patients who are 18-75 years of age
✓. Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
✓. Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor
✓. At least 1 measurable lesion according to the Lugano Classification
✓. ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy \>12 weeks

Exclusion criteria

✕. CNS involvement by malignancy
✕. Inadequate laboratory abnormalities at screening:
✕. Active uncontrolled bleeding or a known bleeding diathesis
✕. Inadequate pulmonary function defined as pulse oximetry \< 90% on room air
✕. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (\>10 mg/day prednisone or equivalent for \>48 hours)
✕. Received prior therapy of:
✕. Active GVHD requiring immune suppression regardless of grade

What they're measuring

To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose

Timeframe: Day 0 to 28 for DLT

Trial details

NCT IDNCT04526834

SponsorTessa Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-22

View on ClinicalTrials.gov More Anaplastic Large Cell Lymphoma trials