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Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma

ConditionsLarge B-cell LymphomaHodgkin Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorM.D. Anderson Cancer Center

About this trial

This clinical research study is to learn if CD70.CAR NK cell therapy can help to control early relapsed or primary refractory DLBCL and cHL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years of age.

Primary refractory, defined as not having achieved a CR with frontline therapy or having relapsed within 3 months.

Early relapsed (≤ 12 months) after achieving a CR to frontline therapy.

Tumor biopsy positive for CD70 >/= 10% by immunohistochemistry or flow cytometry.

Disqualifiers

Lymphoma in CR with no measurable sites of disease.

Major surgery <4 weeks prior to first dose of study drug.

Any other severe or uncontrolled disease or condition which might increase the risk associated with study participation.

Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fludarabine

    Drug

    Given by IV

  • Cyclophosphamide

    Drug

    Given by IV

  • CD70.CAR NK Cells

    Drug

    Given by IV Infusion

  • Rimiducid (AP1903)

    Drug

    Given by IV Infusion

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 1st Dose: Treatment with Rimiducid + CD70.CAR NK Cells for Patients with DLBCL and HLExperimental treatment 4 interventions
Group B: 2nd Dose: Treatment with Rimiducid + CD70.CAR NK Cells for Patients with DLBCL and HLExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Bellicum Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: