CAR T-cells for Hodgkin's Lymphoma

Overseen By Lauren Harrison, MSN

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: New York Medical College

Disqualifiers: Age, Performance score, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for Hodgkin's Lymphoma using specially modified immune cells, called CD30 CAR T-cells, a type of immunotherapy. These cells aim to fight the cancer after a patient receives a stem cell transplant. Researchers aim to determine if these CAR T-cells can assist patients whose cancer has not responded to other treatments or has returned. Suitable candidates for this trial have Hodgkin's Lymphoma that is persistent or recurrent and have already undergone specific cancer treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that CD30 CAR T-cells are likely to be safe for humans?

Research has shown that CD30 CAR T-cells, a treatment tested for Hodgkin's Lymphoma, have produced mixed safety results. Some studies report side effects such as skin rashes and prolonged low blood cell counts, which can be severe for some individuals. However, other research suggests that using these cells after stem cell transplants is generally safe, with few serious side effects.

CAR T-cell treatments are still under study to fully understand their safety. While promising, it is crucial to consider the possible side effects. Prospective participants should consult their healthcare provider to understand the risks and benefits before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Hodgkin's Lymphoma, which often involve chemotherapy and radiation, CD30 CAR T-cells offer a targeted approach by reprogramming the body's own immune cells to attack cancer cells that express the CD30 protein. This treatment works by engineering T-cells to specifically recognize and eliminate these cancerous cells, potentially reducing the collateral damage to healthy cells. Researchers are excited about this treatment because it harnesses the power of the immune system and could lead to fewer side effects and improved outcomes for patients who have not responded well to traditional therapies.

What evidence suggests that CD30 CAR T-cells might be an effective treatment for Hodgkin's Lymphoma?

Research has shown that CD30 CAR T-cells, which participants in this trial will receive, could benefit people with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Studies have found that 62% of patients responded well to this treatment. Patients who received CD30 CAR T-cells often experienced good results and few side effects, even after trying many other treatments. This therapy is considered both effective and safe. With these positive outcomes, CD30 CAR T-cells offer hope for those with challenging cases of Hodgkin lymphoma. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with a high-risk form of Hodgkin Lymphoma who have undergone intense chemotherapy and stem cell transplant. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.

Inclusion Criteria

I am between 6 and 29 years old.

I can do most activities but may need help.

I meet at least two risk factors for my condition based on specific health scores and cancer characteristics.

Exclusion Criteria

Not meeting the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cell Procurement

Collection of peripheral blood mononuclear cells (PBMC) for CD30+ CAR T-cell manufacturing and autologous stem cells (PBSC) for future AutoHSCT

2-4 weeks

Myeloablative Conditioning and AutoHSCT

Patients receive BEAM conditioning followed by autologous stem cell transplantation (AutoHSCT)

3-6 weeks

CAR T-cell Infusion

Patients receive autologous CD30+ CAR T-cell infusion between days 21-42 post AutoHSCT

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and toxicities

2 years

What Are the Treatments Tested in This Trial?

Interventions

• CD30 CAR T-cell

Trial Overview The study tests the use of CD30 CAR T-cells in patients after they've received myeloablative chemotherapy followed by an autologous stem cell transplant to treat poor-risk classical Hodgkin Lymphoma.

How Is the Trial Designed?

Group I: CD30 CAR T-cells Experimental Treatment 1 Intervention

Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42.

Who Is Running the Clinical Trial?

New York Medical College

Lead Sponsor

Trials

73

Recruited

8,700+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Published Research Related to This Trial

CD30-targeting CAR T cell therapy was found to be safe and feasible for patients with relapsed or refractory Hodgkin lymphoma, with only two out of 18 patients experiencing severe toxicities.

Of the 18 patients treated, 7 achieved partial remission and 6 had stable disease, indicating that while the therapy shows promise, responses varied, particularly with lymph nodes responding better than lung lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous T Cells Expressing CD30 Chimeric Antigen Receptors for Relapsed or Refractory Hodgkin Lymphoma: An Open-Label Phase I Trial. Wang, CM., Wu, ZQ., Wang, Y., et al.[2022]

In a study involving 41 heavily pretreated patients with relapsed or refractory Hodgkin lymphoma, CD30-targeted CAR T-cell therapy demonstrated a high overall response rate of 72%, with 59% achieving complete responses after fludarabine-based lymphodepletion.

The therapy showed a favorable safety profile, with most adverse events being grade 3 or higher hematologic issues and only mild cytokine release syndrome observed, indicating that CAR T-cell therapy can be safely extended to treat Hodgkin lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-CD30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma. Ramos, CA., Grover, NS., Beaven, AW., et al.[2022]

Third-generation anti-CD30 CAR T-cells (CD28BBz) show long-term persistence and strong anti-tumor activity in models of Hodgkin lymphoma and anaplastic large cell lymphoma, outperforming second-generation CAR T-cells (CD28z).

These CAR T-cells are well tolerated with minimal side effects, indicating they are a safe and effective treatment option for patients with Hodgkin lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The third-generation anti-CD30 CAR T-cells specifically homing to the tumor and mediating powerful antitumor activity. Zhang, S., Gu, C., Huang, L., et al.[2022]

Chimeric antigen receptor (CAR)-transduced T cells targeting CD30 have shown to be safe and effective in treating Hodgkin lymphoma (HL).

The review also highlights the challenges and ongoing trials of using CAR-T cells targeting CD5 and CD7 in T-cell lymphomas (TCL), indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric Antigen Receptor T Cells in Hodgkin and T-Cell Lymphomas. Muhsen, IN., Hill, LC., Ramos, CA.[2023]

In a study of 38 classical Hodgkin's Lymphoma (cHL) specimens, only 5.2% of Reed-Sternberg cells expressed both CD19 and CD30, indicating a limited population eligible for combined CAR T-cell therapy.

A patient treated with low doses of anti-CD19 and CD30 CAR T-cells did not experience severe adverse events and achieved long-term progression-free survival, suggesting that this approach may be safe and effective for high-risk relapsing/refractory cHL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD19 and CD30 CAR T-Cell Immunotherapy for High-Risk Classical Hodgkin's Lymphoma. Xue, Y., Lai, X., Li, R., et al.[2022]

The study developed a novel CD30-chimeric antigen receptor (CAR) T cell therapy using memory stem T cells (TSCM), which showed improved persistence and antitumor activity against Hodgkin lymphoma in mouse models.

CD30-CAR TSCM-like cells effectively eradicated Hodgkin lymphoma tumors in vivo, demonstrating a survival advantage and enhanced tumor infiltration compared to more differentiated CAR T cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory stem T cells modified with a redesigned CD30-chimeric antigen receptor show an enhanced antitumor effect in Hodgkin lymphoma. Alvarez-Fernández, C., Escribà-Garcia, L., Caballero, AC., et al.[2022]

In a multi-center phase II clinical trial involving 12 patients with relapsed/refractory CD30+ lymphoma, the combination of anti-CD30 CAR-T therapy and PD-1 inhibitors resulted in a high overall response rate of 91.7%, with 50% of patients achieving complete remission.

The treatment demonstrated minimal toxicity, with only 4 patients experiencing cytokine release syndrome, and no cases of CAR-T-related encephalopathy syndrome, indicating a favorable safety profile alongside its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-PD-1 Therapy Enhances the Efficacy of CD30-Directed Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed/Refractory CD30+ Lymphoma. Sang, W., Wang, X., Geng, H., et al.[2022]

Citations

1. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13400-5

Anti-CD30 CAR-T Therapy for Hodgkin Lymphoma: Review Current evidence suggests that anti-CD30 CAR-T cell therapy is effective and safe in treating R/R cHL and is worth considering as a viable therapeutic option.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10394544/

Patient-reported outcomes in CD30-directed CAR-T cells ... We found an overall response rate of 62% in all evaluable patients. With a median follow-up of 533 days, the 1-year progression-free survival ...

3. ashpublications.org ashpublications.org/bloodadvances/article/8/3/799/514908/CARs-for-Hodgkin-engine-fine-tuning-is-in-order

CARs for Hodgkin: engine fine-tuning is in order This is a commentary to: Transient responses and significant toxicities of anti-CD30 CAR T cells for CD30 lymphomas: results of a phase 1 trial.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352302624000644

Anti-CD30 CAR T cells for high-risk CD30+ lymphoma We and others have shown high response rates with minimal toxicity in heavily pre-treated patients with relapsed or refractory Hodgkin lymphoma who received ...

5. nature.com nature.com/articles/s41408-025-01257-1

Outcomes in patients with classic Hodgkin lymphoma ... We demonstrated excellent survival outcomes with patients proceeding to AlloSCT and/or CD30.CAR-T cell therapy after developing DR/INT cHL.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11731380/

Safety and efficacy of anti-CD30 CAR-T cell therapy in ... With the median follow-up range from 9.5 to 71.5 months, the 1-year PFS was 39% (95% CI 0.30–0.49, P = 0.04), and the 1-year OS was 89% (95% CI ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13400-5/tables/3

Table 3 Safety outcomes of anti-CD30 CAR-T cell therapy in R ... Table 3 Safety outcomes of anti-CD30 CAR-T cell therapy in R/R cHL ; CRS. 0.43. 0.14–0.76 ; Anemia. 0.23. 0.08–0.49 ; Thrombocytopenia. 0.23. 0.09–0.47 ; Leukopenia.

8. ashpublications.org ashpublications.org/bloodadvances/article/8/3/802/498655/Transient-responses-and-significant-toxicities-of

Transient responses and significant toxicities of anti-CD30 ... Anti-CD30 CAR T cells had low efficacy in patients with CD30-expressing lymphoma. Rashes and prolonged cytopenias were frequent and severe in some cases, ...

9. jitc.bmj.com jitc.bmj.com/content/11/8/e006959

Patient-reported outcomes in CD30-directed CAR-T cells ... We found an overall response rate of 62% in all evaluable patients. With a median follow-up of 533 days, the 1-year progression-free survival ...