Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

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Results 1 - 10 of 55

A Phase 1/2a, Open-Label Dose Escalation and Cohort Expansion Study of Orally Administered CA-4948 (IRAK4i) as a Monotherapy in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Objective:

Phase 1 Dose Escalation

Primary Objectives:

To evaluate the safety and tolerability of CA-4948 in patients with R/R AML and
hrMDS

To identify the MTD and RP2D

Secondary Objectives:

To characterize the PK parameters of CA-4948 using non-compartmental analysis
and appropriate PK modelling

To assess anti-cancer activity

Phase 2a Dose Expansion

Primary Objective:

To assess anti-cancer activity of CA-4948 at RP2D in patients with R/R AML with
FLT-3 mutations, and patients with R/R hrMDS or R/R AML with spliceosome
mutations of SF3B1 or U2AF1

Secondary Objectives:

To assess tolerability and long-term safety

To further assess anti-cancer activity of CA-4948 at RP2D
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
2023-095
Age Group:
Adult
Phase:
Phase I/II
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A Phase III Randomized Trial of Steroids +Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Objective:

Primary Objectives:

To compare the overall survival (OS) following induction with steroids + TKI + blinatumomab versus induction with steroids + TKI + chemotherapy.

Secondary Objectives:

To compare the rate of MRD negativity for patients treated with chemotherapy vs blinatumomab at the end of first induction (week 15).

To evaluate the rate of the MRD negativity by treatment arm for those patients MRD positive after the first induction and administered of second induction.

To compare event free survival (EFS) for patients initially randomized for chemotherapy vs blinatumomab. (Events include failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission).

To assess the toxicities of blinatumomab+TKI and steroids + TKI + chemotherapy in this patient population.

To assess the toxicities of the chemotherapy regimen in this patient population.

To describe the outcome of patients who proceed to allogeneic stem cell transplant after treatment with blinatumomab+TKI only.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
EA9181
Age Group:
Adult
Phase:
Phase III
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A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission
Objective:

Primary Objective:

To compare overall survival in MCL patients in MRD-negative first complete remission (CR) who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone (without auto- HCT).

Secondary Objectives:

To compare progression-free survival in MCL patients in MRDnegative CR who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone.

To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT.

To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive (including MRD-positive CR and MRD-positive PR) prior to auto-HCT.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
EA4151/BMTCTN1601
Age Group:
Adult
Phase:
Phase III
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Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Objective:
Primary Objective:

To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.

Secondary Objectives of First Randomization:

To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.

To compare progression-free survival (PFS) between the study arms in this patient population.

To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.

To compare toxicities and tolerability of long term therapy between the study arms.

Objectives of Second Randomization:

To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.

To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Kin, Andrew
Karmanos Trial ID:
S1803
Age Group:
Adult
Phase:
Phase III
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A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors
Objective:

Primary Objectives:

To investigate the safety of monotherapy and T- Plex combination TCR-Ts

To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

Secondary Objectives:

To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts

To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
Cancer Categories:
Gynecologic,Hematologic (Blood Cancers),Lung,Skin
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2023-086
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Study of FT522 in Combination with Rituximab in Participants with Relapsed/Refractory B-Cell Lymphoma
Objective:

Primary Objectives:

To evaluate the safety and tolerability of FT522 in combination with rituximab, with or without conditioning chemotherapy

To determine the RP2D for FT522 in combination with rituximab, with or without conditioning chemotherapy

Secondary Objectives:

To evaluate the anti-tumor activity of FT522 in combination with rituximab, with or without conditioning chemotherapy

To characterize the PK of FT522 in combination with rituximab, with or without conditioning chemotherapy
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Deol, Abhinav
Karmanos Trial ID:
2023-042
Age Group:
Adult
Phase:
Phase I
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A Phase 1/2, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Patients with Relapsed/Refractory Multiple Myeloma
Objective:

Primary Objectives

Phase 1:

Assess safety and tolerability of ISB 1442

Determine maximum tolerated dose (MTD) and/or RP2D

Phase 2

Evaluate efficacy of ISB 1442

Secondary Objectives

Characterize the PK profile of ISB 1442

Characterize immunogenicity of ISB 1442

Phase 1:

Assess preliminary efficacy of ISB 1442

Phase 2:

Assess safety and tolerability of ISB 1442

Further characterize efficacy of ISB 1442
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Zonder, Jeffrey
Karmanos Trial ID:
2023-019
Age Group:
Adult
Phase:
Phase I/II
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A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies
Objective:

BGB-16673 Monotherapy Dose Finding (Phase 1)

Primary Objectives:

To evaluate the safety and tolerability of BGB-16673 monotherapy

To define the maximum tolerated dose (or maximum assessed dose) and the
recommended Phase 2 dose (RP2D) of BGB-16673

Secondary Objectives:

To characterize the pharmacokinetic profile of BGB-16673 as monotherapy

To characterize the pharmacodynamic profile of BGB-16673 in peripheral blood

To characterize the preliminary antitumor activity of BGB-16673 monotherapy

BGB-16673 Monotherapy (Phase 2)

Primary Objectives:

To evaluate the antitumor activity of BGB-16673 monotherapy in patients with
relapsed/refractory (R/R) mantle cell lymphoma (MCL) based on overall response
rate (ORR) as assessed by an Independent Review Committee (IRC)

To evaluate the antitumor activity of BGB-16673 monotherapy in patients with R/R
CLL/SLL based on ORR as assessed by investigators

Secondary Objectives:

To evaluate the safety and tolerability of BGB-16673 monotherapy

To further characterize the pharmacokinetic profile of BGB-16673

To further characterize the pharmacodynamic profile of BGB-16673 in peripheral
blood

Patients with R/R MCL:

To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR as
assessed by investigators

To evaluate the antitumor activity of BGB-16673 monotherapy based on best
overall response (BOR), time to response (TTR), duration of response (DOR), and
progression-free survival (PFS) as assessed by the IRC and investigators

To characterize overall survival

To measure patient-reported outcomes (PRO) in R/R MCL patients via National
Comprehensive Cancer Network Functional Assessment of Cancer Therapy –
Lymphoma System Index-18 (NFLymSI-18)

Patients with R/R CLL/SLL:

To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR,
DOR, TTR, and PFS as assessed by investigators

To characterize overall survival
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
2023-094
Age Group:
Adult
Phase:
Phase I/II
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A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a fenretinide phospholipid suspension (12.5 mg/mL) for Intravenous Infusion
Objective:

Primary Objective:

To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ST-001 12.5 mg/mL for IV infusion (ST-001) in patients with Relapsed/Refractory T-cell non-Hodgkin’s lymphoma when ST-001 is administered via 4-hour IV infusion daily for five consecutive days, q3weeks.

Secondary Objectives:

To describe the toxicity profile of ST-001 in patients with CTCL and other T-cell NHL.

To observe and record anti-tumor activity. The previous activity seen with an earlier formulation of fenretinide in the same patient population suggests a likelihood of therapeutic benefit. Thus, patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.

To investigate the clinical pharmacology of ST-001 12.5 mg/mL for IV infusion.

To describe the pharmacokinetics of fenretinide when ST-001 is administered by daily infusion for 5 consecutive days every 3 weeks.

To evaluate potential mechanisms of action of ST-001 with pharmacodynamic biomarkers:

ST-001 increases CTCL cell surface expression of NKG2D receptor ligands, while reducing expression of immunosuppressive cytokines, thereby increasing cytolysis by both CD8+ CTLs and NK cells

ST-001 reduces expression of cytokine ligands for IL-2, -15, -21 receptors, thereby reducing CTCL proliferation driven by constitutive over-expression of the IL2RA subunit
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
2023-056
Age Group:
Adult
Phase:
Phase I
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A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Subjects with Recurrent or Refractory Hodgkin Lymphoma and CD30-Positive Peripheral T-Cell Lymphoma (LuminICE-203)
Objective:

Primary Objective:

Assess the antitumor activity of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCLs by ORR.

Secondary Objectives:

To assess efficacy of AFM13 in combination with AB-101

To assess the incidence of post-treatment transplant

To assess the safety and tolerability of AFM13 in combination with AB-101

To assess the immunogenicity of AFM13 in combination with AB-101
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
2023-062
Age Group:
Adult
Phase:
Phase II
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