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Diffuse Large B-Cell Lymphoma (DLBCL)Phase 1ANCILE-30NCT07729397

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

A Phase 1 study testing Autologous C7R.CD30-CAR-EBVSTs in people with Diffuse Large B-Cell Lymphoma (DLBCL) and Hodgkin Lymphoma, run by The Methodist Hospital Research Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 16 to 75 years
What is being tested?
Autologous C7R.CD30-CAR-EBVSTs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
15 Jan 2027to 28 Feb 2044
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Procurement Inclusion Criteria:

Participants must meet the protocol-defined procurement eligibility criteria before collection of peripheral blood mononuclear cells for manufacture of the investigational product, including:

  1. Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.
  2. CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory.
  3. Age 16 to 75 years.
  4. Hemoglobin ≥7.0(may be transfused value).
  5. Karnofsky or Lansky score of > 60%
  6. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent.

Procurement Exclusion Criteria:

  1. Active HIV or HTLV infection (testing may be pending at procurement).
  2. Active bacterial, fungal, or viral infection. ____________________________________________________________________________

Treatment Inclusion Criteria:

Participants with a successfully manufactured product must continue to satisfy the protocol-defined treatment eligibility criteria before receiving study treatment, including:

  1. 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
  1. CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy
  2. Age 16 to 75 years.
  3. 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).
  4. AST ˂ 3 times the upper limit of normal
  5. Estimated GFR > 50 mL/min
  6. Pulse oximetry of > 90% on room air
  7. Karnofsky or Lansky score of > 60%
  8. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after study is concluded. Male partner should use a condom
  9. Informed consent explained to, understood by and signed by patient/guardian. Patient/Guardian given copy of informed consent.

Treatment Exclusion Criteria:

  1. Received an investigational cell therapy or vaccine within the past 6 weeks.
  2. Received an investigational small molecule 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. Pregnancy or breastfeeding.
  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 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Premal Lulla, MD contact

713-441-1450

lulla@bcm.edu

United States1 site

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Premal Lulla, MD, 713-441-1450, lulla@bcm.edu

Other trials in United States

About this study

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.

Read the detailed description

This is a Phase I study to evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes (EBVSTs) genetically modified to express a constitutively active interleukin-7 receptor (C7R) and a CD30-specific chimeric antigen receptor (CAR) (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas. The study will also evaluate the antitumor effect of C7R.CD30-CAR-EBVSTs, the expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.

Autologous CD30 CAR T cells have demonstrated clinical activity in patients with relapsed or refractory CD30-positive lymphomas but have shown limited persistence. Epstein-Barr virus-specific T lymphocytes (EBVSTs) have demonstrated long-term persistence following adoptive transfer. In this study, EBVSTs are used as the cellular platform to express both a CD30 CAR and a constitutively active IL7 receptor (C7R). The investigational cell product also provides a mechanism for rapid elimination of transduced cells if clinically indicated.

Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of an autologous C7R.CD30-CAR-EBVST product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by intravenous infusion of C7R.CD30-CAR-EBVSTs. Participants who meet retreatment criteria, as defined in the protocol, may receive additional treatment cycles. Following treatment, participants will undergo scheduled follow-up evaluations including physical examinations, laboratory testing, and imaging studies to assess safety and disease status.

Blood samples are collected at multiple time points after infusion to evaluate persistence of the infused cells. Tumor assessments are performed using imaging and, when clinically indicated, biopsy.

Participants are followed longitudinally for up to 15 years after the most recent infusion.

Being tested
Autologous C7R.CD30-CAR-EBVSTs
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
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Lymphoma, T-Cell, Peripheral, Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous C7R.CD30-CAR-EBVSTsBiological

    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.

Study groups in NCT07729397
Study groupRoleWhat they receive
Autologous C7R.CD30-CAR-EBVSTsExperimentalParticipants 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.
Receives: Biological: Autologous C7R.CD30-CAR-EBVSTs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. Antitumor Effect

    Antitumor effect will be assessed by investigator evaluation of objective response (complete response and partial response) using Lugano criteria.[

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start15 Jan 2027 (estimated)
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion28 Feb 2044 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07729397
Sponsor's protocol ID
ANCILE-30
Acronym
ANCILE-30
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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