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Hodgkin Lymphoma, AdultPhase 2NCT04268706

Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)

A Phase 2 study testing CD30.CAR-T, Fludarabine and Bendamustine in people with Hodgkin Lymphoma, Adult and Hodgkin Disease Recurrent, run by Tessa Therapeutics at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma. Read more about this study

Who is it for?
Ages 12 to 75 years
What is being tested?
CD30.CAR-T, Fludarabine and Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
5 sitesUnited States
Study dates
1 Feb 2021to Mar 2037
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Eligibility is determined prior to blood collection . Patients must satisfy the following criteria to be enrolled in the study:
  • Signed Informed Consent Form
  • Male or female patients who are 12 - 75 years of age
  • Histologically confirmed classical Hodgkin Lymphoma
  • Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including:
  • chemotherapy
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  • BV and/or
  • PD-1 inhibitor Patients may have previously received an autologous and/or allogeneic stem cell transplant
  • CD30-positive tumor
  • At least 1 measurable lesion according to The Lugano Classification
  • Laboratory parameters: Hematological, renal and hepatic functions, and coagulation parameters
  • Hgb ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 × ULN
  • AST and ALT ≤ 5 × the ULN
  • CrCl > 45 mL/min
  • ANC >1,000/µL
  • Platelets >75,000/µL
  • PT or INR ≤ 1.5 × ULN; PTT or aPTT ≤ 1.5 × ULN
  • ECOG PS of 0 to 1 or equivalent [either Karnofsky PS (for patients ≥ 16 year of age) or Lansky PS (for patients < 16 years of age)]
  • Anticipated life expectancy > 12 weeks

Who cannot join

  • Evidence of lymphomatous involvement of central nervous system (CNS)
  • Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
  • Active uncontrolled bleeding or a known bleeding diathesis
  • Inadequate pulmonary function defined as pulse oximetry < 90% on room air
  • ECHO or MUGA with LVEF < 45%
  • On-going treatment with immunosuppressive drugs or chronic systemic corticosteroids
Show all 21Show fewer
  • Having received:
  • Anti-CD30 antibody-based therapy within 4 weeks prior to CD30.CAR-T infusion
  • Prior investigational CD30.CAR-T
  • CD30 bispecific agent within 8 weeks prior to CD30.CAR-T infusion
  • Autologous HSCT within 90 days or allogeneic HSCT within 180 days prior to CD30.CAR-T infusion
  • Currently receiving any investigational agents within 4 weeks prior to study enrollment; or received any tumor vaccines within 6 weeks prior to CD30.CAR-T infusion
  • Active acute or chronic graft versus host disease (GVHD) requiring immune suppression regardless of grade
  • Evidence of human immunodeficiency virus (HIV) infection
  • Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments
  • History of hypersensitivity reactions to murine protein-containing products or other product excipients
  • Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification
  • Active second malignancy or history of another malignancy within the last 3 years
  • Women who are pregnant or intending to become pregnant; women who are breastfeeding; persons with procreative potential not using and not willing to use 2 highly effective methods of contraception
  • Any other serious, life-threatening, or unstable preexisting medical conditions

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase 2 Multi-Center Study Evaluating the Safety and Efficacy of CD30-Directed Genetically Modified Autologous T Cells (CD30.CAR-T) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.

Read the detailed description

The Pilot part of the study will evaluate the safety, tolerability, and preliminary antitumor efficacy of CD30.CAR-T. The Pivotal part of the study will evaluate antitumor efficacy and further evaluate safety and tolerability. All study eligibility requirements, assessments, procedures, and follow-up are the same for patients in both Pilot and Pivotal parts of the study.

Subjects who meet eligibility criteria will have their blood drawn by leukapheresis for manufacture the CD30.CAR-T cells. Subjects are allowed bridging chemotherapy, as per Investigator choice, while waiting for production of CD30.CAR-T. Lymphodepletion (LD) with fludarabine and bendamustine will be administered for 3 consecutive days starting on Day -5 to Day -3, prior to CD30.CAR-T infusion, which will be administered on Day 0 as a single IV infusion. Depending on disease status, eligible subjects may receive up to a total of two CD30.CAR-T infusions at the same dose, each with preceding LD chemotherapy.

Subjects will be closely monitored for safety and efficacy throughout the Treatment Period until the end of study (EOS) visit at Month 24. Subjects will be followed for survival, withdrawal of consent or study closure, whichever occurs first. Health Related Quality of Life assessments will also be collected throughout the study. After the EOS visit, subjects will enter the long-term follow-up phase (LTFU) which will include survival follow-up, additional safety, efficacy and biomarker assessments, as clinically indicated.

Being tested
CD30.CAR-T, Fludarabine, Bendamustine
Keywords
r/r Hodgkin Lymphoma, CD30, adult, pediatrics
Medical subject headings
Hodgkin Disease

What participants receive

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

  • CD30.CAR-TDrug

    Autologous CD30.CAR-T cells infused on Day 0 after the completion of lymphodepleting chemotherapy.

  • FludarabineDrug

    Also called Fludara

    Lymphodepletion chemotherapy (30 mg/m2/day) for 3 consecutive days

  • BendamustineDrug

    Also called Bendeka

    Lymphodepletion chemotherapy (70 mg/m2/day) for 3 consecutive days

Study groups in NCT04268706
Study groupRoleWhat they receive
CD30 positive r/r classical Hodgkin LymphomaExperimentalPatients with relapsed or refractory classical Hodgkin Lymphoma who have failed 3 prior lines of treatment, which may include a prior autologous and/or allogeneic stem cell transplant. Patients will be treated with autologous CD30.CAR-T cells.
Receives: Drug: CD30.CAR-T; Drug: Fludarabine; Drug: Bendamustine

What is being measured

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

  1. Pilot: Safety of autologous CD30.CAR-T

    Adverse events

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  2. Pivotal: Anti-tumor effect of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014)

    ORR

    Measured: As early as 6 weeks after CD30.CAR-T treatment

Secondary outcomes (11)

  1. Pilot: Antitumor efficacy of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson et al., 2014)

    ORR

    Measured: As early as 6 weeks after CD30.CAR-T treatment

  2. Pilot: Duration of Response

    DOR

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  3. Pilot: Progression Free Survival

    PFS

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  4. Pilot: Overall Survival

    OS

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  5. Pilot: Health Related quality of life (HRQoL) questionnaire

    QoL

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  6. Pivotal: Number of patients with adverse events as a measure of safety and tolerability of CD30.CART cells

    Adverse events

    Measured: As early as 6 weeks after CD30.CAR-T treatment

  7. Pivotal: Objective response rate (ORR as assessed by IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014)

    ORR

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  8. Pivotal: Progression Free Survival (PFS)

    PFS

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  9. Pivotal: Duration of Response (DOR)

    DOR

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  10. Pivotal: Overall Survival

    OS

    Measured: Minimum 24 months post-CD30.CAR-T infusion

  11. Pivotal: Health Related quality of life (HRQoL) questionnaire

    HRQoL

    Measured: Minimum 24 months post-CD30.CAR-T infusion

Timeline

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

  1. First posted13 Feb 2020
  2. Study start1 Feb 2021
  3. Primary completionMay 2025 (estimated)
  4. Study completionMar 2037 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
97 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268706
Sponsor's protocol ID
TESSCAR001
Status last verified
Apr 2023
First submitted
11 Feb 2020
Last updated
5 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD30.CAR-T, Fludarabine and Bendamustine in people with Hodgkin Lymphoma, Adult and Hodgkin Disease Recurrent, run by Tessa Therapeutics at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pilot: Safety of autologous CD30.CAR-T (time frame: Minimum 24 months post-CD30.CAR-T infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04268706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.

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