Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)

NCT07729397 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ANCILE-30
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30 (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas. Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of the investigational product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by infusion of autologous C7R.CD30-CAR-EBVSTs. The primary objective is to evaluate safety. Secondary and exploratory objectives include evaluation of antitumor effect, expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL); Hodgkin Lymphoma; Peripheral T-cell Lymphoma (PTCL); Anaplastic Large Cell Lymphoma, ALK-Positive; Anaplastic Large Cell Lymphoma, ALK-Negative

Keywords

CD30; Chimeric Antigen Receptor; CAR T Cells; Epstein-Barr Virus-Specific T Lymphocytes; EBVST; Constitutive IL7 Receptor; C7R; Gene Therapy; Cell Therapy; iC9; Inducible Caspase 9

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicities (DLTs)

  Dose-limiting toxicity (DLT) is defined as any of the following considered possibly, probably, or definitely related to study cellular products: (1) Grade 5 event without disease progression; (2) CRS: Grade 4, or Grade 3 not improving to ≤Grade 2 within 72 hours despite therapy; (3) ICANS: Grade 4, or Grade 3 not improving within 72 hours despite therapy; (4) Grade ≥3 IEC-HS; (5) Grade 4 neutropenia or thrombocytopenia not attributable to underlying disease or lymphodepleting chemotherapy and not improving to ≤Grade 2 within 42 days, or Grade 3 thrombocytopenia with clinically significant major bleeding; (6) Grade ≥3 vital organ toxicity (except transient hepatic or renal abnormalities improving to ≤Grade 2 within 7 days); (7) other Grade 3 toxicities not attributable to underlying disease or lymphodepleting chemotherapy and not resolving to ≤Grade 2 within 72 hours; (8) Grade ≥2 allergic reaction to T-cell infusion.

  From initiation of lymphodepleting chemotherapy through 28 days following the initial investigational T-cell infusion.

Secondary Outcomes (1)

• Antitumor Effect

  4 to 6 weeks after the initial C7R.CD30-CAR-EBVST infusion.

Study Arms (1)

Autologous C7R.CD30-CAR-EBVSTs

EXPERIMENTAL

Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of autologous C7R.CD30-CAR-EBVSTs. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by intravenous infusion of autologous C7R.CD30-CAR-EBVSTs. Participants who meet protocol-defined retreatment criteria may receive additional treatment cycles.

Biological: Autologous C7R.CD30-CAR-EBVSTs

Interventions

Autologous C7R.CD30-CAR-EBVSTs BIOLOGICAL

Autologous Epstein-Barr virus-specific T lymphocytes genetically modified to express a constitutively active interleukin-7 receptor (C7R), a CD30-specific chimeric antigen receptor (CAR), and an inducible caspase 9 (iC9) safety switch. The investigational product is manufactured from autologous peripheral blood mononuclear cells and administered by intravenous infusion following lymphodepleting chemotherapy.

Autologous C7R.CD30-CAR-EBVSTs

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the protocol-defined procurement eligibility criteria before collection of peripheral blood mononuclear cells for manufacture of the investigational product, including:
• Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.
• CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory.
• Age 16 to 75 years.
• Hemoglobin ≥7.0(may be transfused value).
• Karnofsky or Lansky score of \> 60%
• Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent.

You may not qualify if:

• Active HIV or HTLV infection (testing may be pending at procurement).
• Active bacterial, fungal, or viral infection.
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• Participants with a successfully manufactured product must continue to satisfy the protocol-defined treatment eligibility criteria before receiving study treatment, including:
• Diagnosis and clinical course falling into one of the following categories:
• Hodgkin lymphoma
• CD30+ aggressive B-cell lymphoma
• ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma
• ALK-positive anaplastic T cell lymphoma
• CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy
• Age 16 to 75 years.
• Bilirubin ≤ 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin ≤ 3 times the upper limit of normal).
• AST ˂ 3 times the upper limit of normal
• Estimated GFR \> 50 mL/min
• Pulse oximetry of \> 90% on room air

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Hodgkin Disease; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Study Officials

• Helen Heslop, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Premal Lulla, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Premal Lulla, MD

CONTACT

713-441-1450; lulla@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label, Phase I dose-escalation study evaluating autologous C7R.CD30-CAR-EBVSTs administered following lymphodepleting chemotherapy in patients with relapsed or refractory CD30-positive lymphomas. Participants meeting retreatment criteria may receive additional treatment cycles.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): February 28, 2044
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)