Banked C7R-modified allogeneic CD30-targeted CAR T cells for CD30-positive lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 dose-escalation trial uses partially HLA-matched, banked allogeneic T cells engineered with a CD30-directed CAR and a constitutively active IL7 receptor (C7R) to treat relapsed or refractory CD30-positive lymphomas. Participants are assigned to one of four escalating dose cohorts and may receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine before a single intravenous infusion of the product. A CLIA-certified pathology test for CD30 and HLA typing are required to select the best-matched banked product, and patients are closely monitored for toxicity and early signs of response. The primary focus is safety and determining a tolerable dose, with secondary collection of preliminary efficacy and biological activity data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis and clinical course falling into one of the following categories:

   1. Hodgkin lymphoma
   2. CD30+ aggressive B-cell lymphoma
   3. ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma
   4. ALK-positive anaplastic T cell lymphoma
2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
3. Age 12 to 75.
4. Bilirubin less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).
5. AST less than 3 times the upper limit of normal.
6. Estimated GFR \> 70 mL/min.
7. Pulse oximetry of \> 90% on room air
8. Karnofsky or Lansky score of \> 60%.
9. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
11. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.

Exclusion Criteria:

1. Received an investigational cell therapy or vaccine within the past 6 weeks.
2. Received an investigational small molecule drug within the past 2 weeks.
3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.
4. History of hypersensitivity reactions to murine protein-containing products.
5. Pregnant or lactating.
6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
7. Current use of systemic corticosteroids at a dose equivalent to or higher than 10 mg/day of prednisone.
8. Active significant, uncontrolled bacterial, viral or fungal infection.
9. Symptomatic cardiac disease (NYHA Class III or IV disease).

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Premal Lulla, MD — The Methodist Hospital Research Institute
• Study coordinator: Premal Lulla, MD
• Email: pdlulla@houstonmethodist.org
• Phone: 713-441-1450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.