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

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas

This will try a donated (banked) C7R.CD30.CAR-EBVST cell infusion to treat people aged 12–75 whose CD30-positive lymphoma has returned or not responded to prior treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Baylor College of Medicine (other)
• Drugs / interventions: chemotherapy, prednisone, CAR T, cyclophosphamide, fludarabine
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT06176690 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12–75 with relapsed or refractory CD30-positive Hodgkin lymphoma or aggressive CD30-positive non-Hodgkin lymphomas who meet organ function and performance status requirements.

Not a fit: Patients whose tumors lack CD30 expression, who have poor organ function or active uncontrolled infection, or who cannot remain close to the treatment center for intensive post-infusion monitoring are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide an off-the-shelf CAR-T option that produces durable remissions for patients with relapsed or refractory CD30-positive lymphomas.

How similar studies have performed: Autologous CD30 CAR-T studies have shown encouraging responses and early allogeneic CD30 CAR efforts report activity, but the banked C7R-modified product represents a largely novel, unproven strategy.

Eligibility criteria

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 this trial is running

Houston, Texas and 1 other locations

• 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 — Baylor College of Medicine
• Study coordinator: Premal Lulla, MD

Conditions: CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, Anaplastic Large Cell Lymphoma, ALK-Positive, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, CD30-Positive Lymphoma