Clinical Studies

The 4 clinical trials currently active include the following studies (trial sites include MD Anderson Cancer Center and Oncology San Antonio):

  1. Treatment of patients with Progressive and/or Refractory Solid Malignancies
  2. Treatment of patients with Progressive and/or Refractory Hematologic Malignancies
  3. Consolidation therapy in patients with Metastatic Solid Malignancies
  4. Consolidation therapy in patients with Hematologic Malignancies

These protocols evaluate the effectiveness of Tumor Associated Peptide Antigens (TAPA) pulsed dendritic cell injections as a potential therapy for 4 different clinical scenarios for both solid and hematologic malignancies (most solid and hematologic indications are included such as prostate, breast, colon, pancreas, AML, etc). The investigators hypothesize that treatment of patients whose tumor cells and/or blood express at least one (1) TAPA of a defined panel of TAPAs will result in TAPA-specific T-cell responses without significant toxicities. The investigators also hypothesize CD4+ and CD8+ T-cell responses generated against specific TAPAs may translate into clinical antitumor activity.

To obtain more information about Kiromic’s clinical trials, please go to clinicaltrials.gov, and under Terms, search for BSK01. After reviewing the inclusion and exclusion criteria, if you are interested in possible enrollment, please contact the clinical study coordinator.

Oncology San Antonio: Rosie Ferniz, Clinical Trial Coordinator rferniz@kiromic.com
MD Anderson Cancer Center: Cecilia Brion, Research Nurse Coordinator cvvbrion@mdanderson.org

In order to enable the most accurate targeting of solid and hematologic malignancies Kiromic is conducting FOUR clinical trials to effectively reprogram a patient’s immune system into specifically targeting cancer cels thereby translating into a potent and unique clinical antitumor activity.

Consolidation Therapy in Patients With Hematologic Malignancies

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Description

Patients diagnosed with hematologic malignancies (as defined) who have responded to conventional therapy, and without any potentially curative therapeutic intervention, will be candidates for this Phase I/II study. Following confirmation of disease response to conventional antineoplastic therapy, eligible patients who agree to participate and sign a consent form will have their tumor cells and/or blood analyzed for the expression of a specific panel of Tumor Associated Peptide Antigens (TAPAs), including SP17, Ropporin, AKAP4, PTTG1 and Span-xb. Patients whose tumors express one (1) or more of these TAPAs will receive three (3) days of subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to increase bone marrow production of monocytes and dendritic cell (DC) precursors, and peripheral blood mononuclear cells will be obtained by phlebotomy and/or leukapheresis for generation of autologous DCs. Patient’s DCs will be generated at Kiromic’s Cell Processing Good Manufacturing Process (GMP) facility, according to established Standard Operating Procedures, and activated by pulsing/loading them with the TAPA(s) relevant for each particular patient. Patients will receive five (5) days of low-dose cyclophosphamide prior to each vaccination with TAPA-pulsed DCs to decrease Treg activity. TAPA-pulsed DCs will be administered at a fixed dose of up to 1 x 107 DCs at least two (2) days following cyclophosphamide administration. DC vaccination schedule will be once every fourteen (14) days via subcutaneous (SC) and intradermal (ID) injections for a total of 6 vaccinations. Low dose GM-CSF will also be administered SC for five (5) consecutive days, starting three (3) to six (6) hours after each TAPA-pulsed DC treatment, to optimize immune response and DC viability in vivo. Patients will be followed on a weekly basis (or more frequently if required) to evaluate treatment-related toxicity. Immune responses and anti-tumor responses will be evaluated per protocol specifications. Continuation and stopping rules for the study will be defined based on toxicity/tolerability (Phase I) and/or immune responses (Phase II).

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Contact Info

Scott Dahlbeck, MD  |  713-689-4450  |  sdahlbeck@kiromic.com

Consolidation Therapy in Patients With Metastatic Solid Malignancies

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Description

Patients diagnosed with metastatic solid malignancies (SM), who have responded or whose disease remains stable following first line systemic therapy, and without available, potential curative therapeutic options, will be candidates for this Phase I/II study. Potentially eligible patients who agree to participate and sign a consent form will have their neoplastic cells and/or blood analyzed for the expression of a specific panel of Tumor Associated Peptide Antigens (TAPAs), including Sp17, ropporin, AKAP-4, PTTG1, Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1. Patients whose tumors express one (1) or more of these TAPAs will receive three (3) days of subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to increase bone marrow production of monocytes and dendritic cell (DC) precursors, and whole blood will be obtained by phlebotomy and/or leukapheresis for generation of autologous DCs. Patient’s DCs will be generated in Kiromic’s Cell Processing Good Manufacturing Process (GMP) facility, according to established Standard Operating Procedures, and activated by pulsing/loading them with the TAPA(s) relevant for each particular patient. Patients will receive five (5) days of low-dose cyclophosphamide prior to each vaccination with TAPA-pulsed DCs to decrease Treg activity. TAPA-pulsed DCs will be administered at a fixed dose of up to 1 X 107 DCs at least two (2) days following cyclophosphamide administration. DC vaccination schedule will be once every fourteen (14) days via subcutaneous (SC) and intradermal (ID) injections for a total of 6 vaccinations. Low dose GM-CSF will also be administered SC for five (5) consecutive days, starting three (3) to six (6) hours after each TAPA-pulsed DC treatment, to optimize immune responses. Patients will be followed on a weekly basis (or more frequently if required) to evaluate treatment-related toxicity. Immune responses and anti-tumor responses will be evaluated per protocol specifications. Continuation and stopping rules for the study will be defined based on toxicity/tolerability (Phase I) and/or immune responses (Phase II).

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Contact Info

Scott Dahlbeck, MD  |  713-689-4450  |  sdahlbeck@kiromic.com

Treatment of Patients With Progressive and/or Refractory Solid Malignancies

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Description

Patients whose tumors express one (1) or more of these TAPAs will receive three (3) days of subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to increase bone marrow production of monocytes and dendritic cell (DC) precursors, and whole blood will be obtained by phlebotomy and/or leukapheresis performed for generation of autologous DCs. Patient’s DCs will be generated in Kiromic’s Cell Processing GMP facility, according to established Standard Operating Procedures, and activated by pulsing/loading them with the TAPA(s) relevant for each particular patient. Patients will receive five (5) days of low-dose cyclophosphamide prior to each vaccination with TAPA-pulsed DCs to decrease Treg activity. TAPA-pulsed DCs will be administered at a fixed dose of up to 1 X 107 DCs at least two (2) days following cyclophosphamide administration. DC vaccination schedule will be once every fourteen (14) days via subcutaneous (SC) and intradermal (ID) injections for a total of 6 vaccinations. Low dose GM-CSF will also be administered SC for five (5) consecutive days, starting three (3) to six (6) hours after each TAPA-pulsed DC treatment, to optimize immune responses. Patients will be followed on a weekly basis (or more frequently if required) to evaluate treatment-related toxicity. Immune efficacy and anti-tumor responses will be evaluated per protocol specifications. Continuation and stopping rules for the study will be defined based on toxicity/tolerability (Phase I) and immune efficacy (Phase II).

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Contact Info

Scott Dahlbeck, MD  |  713-689-4450  |  sdahlbeck@kiromic.com

Therapy for Progressive and/or Refractory Hematologic Malignancies

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Description

Patients diagnosed with progressive and/or refractory hematologic malignancies, who have failed conventional therapy and have no potentially curative therapeutic options available, will be candidates for this Phase I/II study. Following confirmation of disease progression and/or refractoriness, eligible patients who agree to participate and sign a consent form will have their neoplastic cells and/or blood analyzed for the expression of a specific panel of Tumor Associated Peptide Antigens (TAPAs), including SP17, Ropporin, AKAP4, PTTG1 and Span-xb. Patients whose tumors express one (1) or more of these TAPAs will receive three (3) days of subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to increase bone marrow production of monocytes and dendritic cell (DC) precursors, and peripheral blood mononuclear cells will be obtained by phlebotomy and/or leukapheresis for generation of autologous DCs. Patient’s DCs will be generated at Kiromic’s Cell Processing GMP facility, according to established Standard Operating Procedures, and activated by pulsing/loading them with the TAPA(s) relevant for each particular patient. Patients will receive five (5) days of low-dose cyclophosphamide prior to each vaccination with TAPA-pulsed DCs to decrease Treg activity. TAPA-pulsed DCs will be administered at a fixed dose of up to 1 x 107 DCs at least two (2) days following cyclophosphamide administration. DC vaccination schedule will be once every fourteen (14) days via subcutaneous (SC) and intradermal (ID) injections for a total of 6 vaccinations. Low dose GM-CSF will also be administered SC for five (5) consecutive days, starting three (3) to six (6) hours after each TAPA-pulsed DC treatment, to optimize immune response and DC viability in vivo. Patients will be followed on a weekly basis (or more frequently if required) to evaluate treatment-related toxicity. Immune responses and anti-tumor responses will be evaluated per protocol specifications. Continuation and stopping rules for the study will be defined based on toxicity/tolerability (Phase I) and/or immune efficacy (Phase II).

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Contact Info

Scott Dahlbeck, MD  |  713-689-4450  |  sdahlbeck@kiromic.com
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