CAR T Cells for Lymphoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Houston Methodist Hospital, Houston, TX
Lymphoma+2 More
CAR T Cells - Genetic
Eligibility
Any Age
All Sexes
Eligible conditions
Lymphoma

Study Summary

CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)

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Eligible Conditions

  • Lymphoma
  • Lymphoma, Hodgkins
  • Non-Hodgkin's Lymphoma (NHL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CAR T Cells will improve 1 primary outcome and 3 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 6 weeks.

15 years
Mean Number of T cells transduced with the vector
Median Number of T cells transduced with the vector
6 weeks
Number of Patients with Dose-Limiting Toxicities (DLT)
8 weeks
Overall Response Rate

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
CD30.CAR T Cells

This trial requires 66 total participants across 2 different treatment groups

This trial involves 2 different treatments. CAR T Cells is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

CD30.CAR T CellsEach patient will receive one infusion of CAR modified T cells. Unless post autologous transplant, patients will receive Cyclophosphamide and Fludarabine to induce lymphopenia. Patients post autologous stem cell transplantation will receive T cell infusion starting at least 14 days after the date of transplant, unless there is clear evidence of relapse, then T-cell infusion can occur at any time after transplant. No lymphodepleting chemotherapy will be given to these patients.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 15 years for reporting.

Who is running the study

Principal Investigator
C. R.
Prof. Carlos Ramos, Associate Professor
Baylor College of Medicine

Closest Location

Houston Methodist Hospital - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Lymphoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of relapsed/refractory HL or NHL.
CD30-positive tumor as assayed in a CLIA certified pathology laboratory.
Age 16 to 75 for the first three patients on a dose level; thereafter, if no DLT, patients aged 12 to 75 can be treated on that dose level.
Bilirubin 1.5 times or less than the upper limit of normal.
AST 3 times or less than the upper limit of normal.
CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time)
Hgb ≥ 7.0 (may be a transfused value)
Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Karnofsky or Lansky score of > 60%
Estimated GFR > 70 mL/min.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes lymphoma?

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Immune system issues and lifestyle factors have been linked to non-Hodgkin's lymphoma. More work is needed to evaluate the relationship between lifestyle factors and B-cell lymphoma.

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Has car t cells proven to be more effective than a placebo?

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Recent findings indicate that Car T cell-based immunotherapies as a first-line treatment may be the most important achievement obtained in the field of T cell treatments.

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What are common treatments for lymphoma?

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Common chemotherapeutic agents found to be effective included Cyclophosphamide, CHOP, VB and AC, the latter two by far the most common. The most commonly reported combinations included Cyclophosphamide and VB, Cyclophosphamide with VB, VBT and VB plus AC, VBT+CHOP+VAC, VBT plus CHOP, CHP with VB and the less common combinations of CHOP+VAC, CHOP+ABC, VB, CHOP+AB and VBT.

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What is lymphoma?

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Lymphoma is one of the fastest growing cancers in the UK and one of the top five cancer killers. Lymphoma has 3 distinct categories, Hodgkin's Lymphoma, non-Hodgkin's Lymphoma and [mantle cell lymphoma](https://www.withpower.com/clinical-trials/mantle-cell-lymphoma). The most common sites of lymphoma are the lymph nodes (15%), blood and gastrointestinal tissues (8%), bone/muscle (8%) and mucosal tissues (5%).\n

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What are the signs of lymphoma?

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A significant majority of patients have an indicator of lymphoma. The most common symptom is persistent weight loss, but any gastrointestinal or weight change should be evaluated. Imaging often reveals a wide systemic dissemination, including the lungs and bone marrow. Testicular enlargement raises suspicion of non-Hodgkin's lymphoma.

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Can lymphoma be cured?

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Currently, there is no cure for lymphoma. However, significant gains have been made in cancer treatment, and the prognosis for cancer patients now is very good. For patients with lymphoma, cure is not possible.

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How many people get lymphoma a year in the United States?

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One in 200 men will develop non-Hodgkin's Lymphoma. The relative risk of developing non-Hodgkin's Lymphoma increases as men age; men who develop non-Hodgkin's Lymphoma are almost three and a half times more likely than men who never develop lymphoma to have an exposed male first degree relative with lymphoma. Risk factors for non-Hodgkin's lymphoma are more broadly defined than risk factors for Hodgkin's lymphoma.

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Have there been any new discoveries for treating lymphoma?

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Since the 1990s, there has been a dramatic decrease in long- term survival of patients with non-Hodgkin's lymphoma, and recent research has yielded significant advances in understanding the mechanisms of this disease and developing new techniques for treating non-Hodgkin's lymphoma, particularly in the areas of immune function, oncogene therapies, and cellular immunity. Patients with non-Hodgkin's lymphoma have demonstrated excellent responses to chemotherapy. However, there is still a need for effective treatments for other B-cell lymphomas. Further clinical research remains required for the identification of effective treatments for patients with multiple disparate types of lymphoma and the development of novel agents or chemotherapy regimens for improving OS.

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Have there been other clinical trials involving car t cells?

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We found that CAR-T and CAR-T + cyclophosphamide are not promising candidates for clinical investigation, and the role of CAR-T in treatment of aggressive lymphomas remains unfound. However, we believe that these results and the literature herein will be helpful when looking at the potential clinical benefit of CAR-T in other lymphoma subtypes in the near future.

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How serious can lymphoma be?

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Patients with low-intermediate-grade (I-I) NHL have a shorter remission time, a higher relapse risk and a lower survival time than patients with high-grade (H) NHL, particularly if they're of B cell origin; therefore high-grade B cell lymphomas should be addressed as the most harmful. Nevertheless, the treatment with standard chemotherapy (CTX) alone or with combined therapy (RTX) has proven to be efficacious in several types of NHL, particularly in patients with low-intermediate-grade (I-I) NHL and in those in partial remissions after chemotherapy.

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What are the common side effects of car t cells?

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A variety of common and common uncommon side effects have been described. Common side effects were fatigue, nausea, diarrhea, pain in extremities that often subsided in less than a day, headache and insomnia in 2 or 3% of the patients. Pain in the extremities was the most common very uncommon side effect. It is most frequently present in women, starts in the upper extremities and fades after 24 hours. While we rarely saw itchiness nor pain in the nose or throat when using the car t cell infusion our patients have been mostly female with breast cancer. This pain is probably due to high concentrations of MDA2.

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What are the latest developments in car t cells for therapeutic use?

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This novel approach of car and cT cells from CAR adoptive cell transfer has promising therapeutic implications for the treatment of hematological malignancies or tumors that are non-responsive to therapy, particularly relapsed disease.

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