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Cytokine

ALT803 for Rectal Cancer

Phase 1
Waitlist Available
Research Sponsored by David Wald
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologic confirmation of relapsed and or refractory hematologic malignancy, locally advanced or metastatic colon/rectal carcinoma, or refractory and/or relapsed soft tissue sarcomas and have failed at least one standard line of therapy.
Patients will be eligible if they have either declined standard treatment regimens or if there is no standard approach to curative salvage therapy per National Comprehensive Cancer Network (NCCN) guidelines in the setting of relapsed/refractory disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after beginning treatment
Awards & highlights

Study Summary

This trial is testing if it's safe to give cancer patients NK cells from donors who aren't a perfect match, and if it helps, they'll also get a drug to help the NK cells grow and fight cancer.

Eligible Conditions
  • Rectal Cancer
  • Rhabdomyosarcoma
  • Soft Tissue Sarcoma
  • Chronic Lymphocytic Leukemia
  • Hodgkin's Lymphoma
  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Colorectal Cancer
  • Myeloproliferative Syndrome
  • Non-Hodgkin's Lymphoma
  • Ewing Sarcoma
  • Myelodysplastic Syndrome
  • Multiple Myeloma
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after beginning treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after beginning treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alanine Transaminase
Number of participants without Graft Versus Host Disease (GVHD)
Secondary outcome measures
Average duration of Overall Survival
Average duration of relapse free survival
Average duration of response
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cytokine ArmExperimental Treatment2 Interventions
Two infusions of Natural Killer (NK) cells and ALT803
Group II: No Cytokine ArmActive Control1 Intervention
Two infusions of Natural Killer (NK) Cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natural Killer (NK) Cells
2018
Completed Phase 1
~20
ALT803
2018
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

David WaldLead Sponsor
Brenda Cooper, MDLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
David Wald, MD, PhDStudy DirectorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025