Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2036-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas

NCT04288726

Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type Classical Hodgkin Lymphoma

RECRUITING PHASE1

Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas

NCT04952584

Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type Classical Hodgkin Lymphoma

WITHDRAWN PHASE1

Administration of T Lymphocytes for Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma (CART CD30)

NCT01316146

Non-Hodgkin's Lymphoma Hodgkin's Lymphoma

WITHDRAWN PHASE1

Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL

NCT02690545

Lymphoma Lymphoma, Non-Hodgkin Immune System Diseases +5 more

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells

NCT06090864

Hodgkin Lymphoma Relapse Refractory

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells.

CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine.

Subjects will be closely monitored for DLT and safety.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anaplastic Large Cell Lymphoma Peripheral T Cell Lymphoma Extranodal NK/T-cell Lymphoma Diffuse Large B Cell Lymphoma Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CD30 positive NHL subtypes

(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL)

Dose Level 1

Dose Level 2

Dose Level 3

Group Type EXPERIMENTAL

CD30.CAR-T

Intervention Type DRUG

Bendamustine and Fludarabine (3 days)

Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0)

Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0)

Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CD30.CAR-T

Bendamustine and Fludarabine (3 days)

Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0)

Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0)

Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CD30-directed genetically modified autologous T cells

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:

1. Signed Informed Consent Form
2. Male or female patients who are 18-75 years of age
3. Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
4. Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor
5. At least 1 measurable lesion according to the Lugano Classification
6. ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy \>12 weeks

Exclusion Criteria

1. CNS involvement by malignancy
2. Inadequate laboratory abnormalities at screening:

Hgb ≤ 8.0 g/dL Total bilirubin \> 1.5 x ULN (\>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR \>1.5 x ULN aPTT\> 1.5 x ULN
3. Active uncontrolled bleeding or a known bleeding diathesis
4. Inadequate pulmonary function defined as pulse oximetry \< 90% on room air
5. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (\>10 mg/day prednisone or equivalent for \>48 hours)
6. Received prior therapy of:

Anti-CD30 Ab based therapy within the previous 8 weeks Previous CD30.CAR-T investigational product Bi-specific CD30 Ab within the previous 8 weeks Allogenic HSCT in the last 180 days Autologous HSCT within 90 days
7. Active GVHD requiring immune suppression regardless of grade
8. HIV positive
9. Active HBV and/or HCV

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No